Smoking Cessation, Tobacco Use Disorder
Conditions
Keywords
Pharmacogenetics, Emotional Reactivity, Smoking Cessation Counseling, Smoking, Bupropion, Wellbutrin, Wellbutrin SR, Zyban, Varenicline, Chantix, Placebo
Brief summary
The goals of this placebo-controlled randomized clinical trial were to evaluate the differences in emotional reactivity (peak startle response to affective stimuli) during a cessation attempt among smokers treated with bupropion, varenicline, or placebo, and to determine if these differences were moderated by genotype.
Detailed description
Bupropion and Varenicline are smoking cessation aids that may help people to quit smoking. During the orientation visit, the study will be explained to you and you will be given an opportunity to ask, and have answered, any questions you may have. You will also be asked to give a buccal (cheek cell) sample for genetic analysis. This session will last about 1.5 hours. During the screening visit, you will be asked questions about your health, medication use, smoking history, and tobacco use. You will be asked about any current or past feelings of depression. Also, a small blood sample will be drawn (about 2 tablespoons) from your upper arm for a liver and kidney function test and a saliva sample will be collected to measure whether you are smoking. Women who are able to have children must have a negative urine pregnancy test. This session will last about 2.5 hours. If you are eligible to take part in the study, you will be randomly assigned (as in the toss of a coin) to one of three treatment groups. Participants in the first group will receive Bupropion. Participants in the second group will receive Varenicline. Participants in the third group will receive a placebo. A placebo is a substance that looks like the study drug but which has no active ingredients. You will have an equal chance of being assigned to the Bupropion, Varenicline, or placebo treatment group. Neither you nor your counselor will know to which group you were assigned. All participants will take study pills (either Bupropion, Varenicline, or placebo) by mouth for 12 weeks. The dose of study medication may or may not change during the study. You will be responsible for returning any unused, used, or partly used study medication bottles to a study staff member. All participants will receive smoking cessation counseling to help them quit smoking, in the form of both in-person and telephone counseling sessions. Some of the counseling sessions may be videotaped or audio-taped. The videotapes will be used to help the investigators make sure that the counselors are following the correct procedures and will be erased within one year following your completion of the study. No one but the study investigators or those delegated by the study investigators will be allowed to view the tapes and the identity of the participants will be kept strictly confidential. Staff that may be given permission to view the tapes include project staff, consultants that review and rate how well the study counselors follow guidelines, and/or consultants that review how well the assessments are given. You will need to come to the Behavioral Science Research Clinic at M. D. Anderson for 9 clinic visits over an 8-month period. You will receive 5 telephone calls from the study staff (while in treatment and during follow-up) to check on your progress in quitting smoking. You will complete your first lab evaluation session (baseline) before any treatment begins (while you are still smoking). Immediately after the baseline lab session (on the same day), you will begin to receive counseling to quit smoking. You will begin taking one of the 3 study medications (Bupropion, Varenicline, or placebo) the next morning. There will be 3 lab sessions, during which you will be asked to complete questionnaires about your mood and feelings (about 30 minutes total). Also, you will give a breath sample by blowing air into a small tube. This sample shows how much you have smoked. In each session you will be asked to watch slides and listen to a series of tones through earphones. The slides will include pictures of people, nature scenes, and artwork. Slides showing victims of car crashes, medical procedures, and nude people will also be shown. You will be shown examples of these slides before beginning the procedure and given the opportunity to withdraw from the study. During the lab sessions, your heart rate, brain electrical activity (EEG), skin sweating, and muscle tension will be monitored. To do this, small sensors will be placed on the fingers, arms, scalp and face. You should not drink more than 2 cups of coffee or other caffeine drinks at least 2.5 hours before each session. During the first counseling visit, you will set a quit date for stopping smoking about 2 weeks after starting your study medication. You are asked not to quit smoking before the set quit date. After your quit date, you are asked to stay smoke free. You are asked to attend all your sessions whether you are smoking or not. All participants will receive smoking cessation counseling in the form of both in-person and telephone counseling sessions. The purpose of these visits will be to prepare you for quitting and to check the effects of the study medication on your attempt to stop smoking. At each of your clinic visits, your blood pressure will be taken and you will be asked to blow air through a carbon monoxide (CO) measuring device. CO is a gas that is found in higher levels among cigarette smokers. At several visits you will be asked to provide a saliva sample to check for cotinine, a chemical produced by the breakdown of nicotine during smoking. You will be asked to give a saliva sample in a collection tube. Like the CO test, this test will help researchers measure how much you are smoking. At your visits you will be asked questions about your smoking behavior. You will also be asked questions about your health and medical condition, and about any medications you are taking. You will be asked to complete a daily diary on cigarette smoking and drug dosing. You will also be asked to mail saliva samples back to the clinic at least two times after stopping the medication. This will allow researchers to check on your smoking status. Your total participation in this study will last about 8 months. This will include a 3-month and 6-month follow-up visit after your scheduled quit date. If the study staff is not able to reach you by phone, mail, or the information provided by your contacts, they may try to locate you through telephone directory assistance (411) or internet search sources (for example, Google or Yahoo!), which use information from the public domain (meaning everyone has access to it). If the study staff is still unable to find you, they may use a locator service such as Transunion or the National Change of Address (NCOA) database maintained by the United States Postal Service, as a last resort. Transunion uses magazine subscriptions and credit applications to find new addresses, and the NCOA uses the Change of Address cards filed with the post office when a person moves and requests their mail be forwarded to a new address. If the study staff has to use either of these services, they would only disclose your name and last known address. At the end of the study, you will be able to ask additional questions about the results of the study and about procedures you have experienced during the study. Additionally, you will be able to sign up to receive a copy of the paper that will be written at the completion of the study. This is an investigational study. Up to 375 smokers will take part in this study. All will be enrolled at MD Anderson.
Interventions
DRUGVarenicline
Starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter)
DRUGBupropion
Starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter)
DRUGPlacebo
Placebo by mouth for 12 weeks.
BEHAVIORALSmoking Cessation Counseling
Counseling over 8 months and telephone support calls.
Sponsors
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age: 18-65 years old 2. Smoking: \>/= 5 cigarettes per day within the 2 months preceding the screening visit and expired CO greater than or equal to 6 ppm. 3. Able to follow verbal and written instructions in English and complete all aspects of the study 4. Have an address and home telephone number where they may be reached 5. Provide informed consent and agree to all assessments and study procedures 6. Be the only participant in their household
Exclusion criteria
1. Within the month immediately preceding the screening visit; use of any form of tobacco product other than cigarettes on 3 or more days within a week only if the individual refuses to refrain from non-cigarette tobacco use during the course of this study 2. Within the month immediately preceding the screening visit; use of marijuana in any form on 3 or more days within a week 3. Within the two weeks immediately preceding the screening visit, involvement on more than 3 days in any formal smoking cessation activities 4. Current visual or auditory problems that in the opinion of the investigator would interfere with the completion of study assessments 5. Treatment on a continuous basis within 2 weeks before the screening visit: any contraindicated medication for Varenicline or Bupropion. 6. Uncontrolled hypertension or other major contraindications for Bupropion or Varenicline. 7. Severe renal impairment (CR Clearance \<30 ml/min/1.73 m2). 8. Laboratory evaluations outside normal limits and of potential clinical significance in the opinion of the investigator 9. Meet current criteria for psychiatric disorders or substance abuse as assessed by the MINI for items A, B, D, I, J, K, L, M and N, including a past manic or hypomanic episode as well as a lifetime psychotic disorder. 10. Subject rated as moderate to high on suicidality as assessed by the MINI. 11. Psychiatric hospitalization within 1 year of screening date. 12. A positive urine pregnancy test during the screening period. Women who are two years post menopausal, one year post-tubal ligation, or who have had a partial or full hysterectomy will not be subject to a urine pregnancy test. 13. Pregnant, breast-feeding, or of childbearing potential who is not protected by a medically acceptable, effective method of birth control while enrolled in the study 14. Use of Varenicline or Bupropion within two weeks before the screening visit. 15. History of hypersensitivity or allergic reaction to Varenicline, tricyclic antidepressant, Bupropion (Wellbutrin, Zyban) or similar chemical classes or any component of these formulations. 16. Subject considered by the investigator as unsuitable candidate for receipt of an investigational drug, or unstable to be followed up throughout the entire duration of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Emotional Reactivity By Pharmacotherapy | Baseline to 1 month | Emotional reactivity measured by the peak eye blink electromyography (EMG) of the orbicularis oculi (ORB) muscle responses to acoustic startle probe delivered during the presentation of emotionally valent stimuli (pleasant, unpleasant, neutral, and smoking-related pictures). A single value was estimated by averaging within the specific time interval. |
| Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele | Baseline to 1 month | The emotional reactivity (ORB EMG) of smokers during cessation will be moderated by genotype. A single value was estimated by averaging within the specific time interval. During a quit attempt, smokers were evaluated on how they react to smoking related cues. An interaction term was then formed by the reactivity to smoking stimulus and genotype. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Smoking Abstinence at 6 Months | Abstinence at 6 Months ( the effects shown are the increase/decrease in probability of abstinence for 1 unit increase in the predictor) | Values represent change in probability of abstinence for unit change in emotional reactivity. Abstinence data collected using a timeline follow-back (TLFB) procedure. Continuous Abstinence was defined as no smoking within the last 4 weeks of treatment. It is scored as 0 if the participant smoked during the specific interval, and 1 if the participant abstained from smoking. |
| Abstinence at 6 Months by DRD2 A1 Allele | Baseline to 6 Month ( the effects shown are the increase/decrease in probability of abstinence for 1 unit increase in the predictor) | Values represent change in probability of abstinence for unit change in emotional reactivity. Abstinence data collected using a timeline follow-back (TLFB) procedure. Continuous Abstinence was defined as no smoking within the last 4 weeks of treatment. It is scored as 0 if the participant smoked during the specific interval, and 1 if the participant abstained from smoking. |
| Symptoms of Nicotine Withdrawal Using the Wisconsin Smoking Withdrawal Scale (WSWS) | Baseline to 8 months | Symptoms of nicotine withdrawal measured using Wisconsin Smoking Withdrawal Scale (WSWS). The Wisconsin Withdrawal Scale (WSWS) contains 7 factors: Anger, Anxiety, Sadness, Concentration, Craving, Sleep, and Hunger. WSWS consists of 28 items that are scored on a 5-point Likert type scale (0 = strongly disagree, 4 = strongly agree). A single value was estimated by averaging within the specific time interval. Higher values represent worse outcome. The average value was estimated from Baseline to 8 months |
| Symptoms of Nicotine Withdrawal and Negative Affect Using Positive and Negative Affect Scale (PANAS) | Baseline to 8 months | Symptoms of nicotine withdrawal and negative affect were measured using the Positive and Negative Affect Scale (PANAS). The Positive and Negative Affect Schedule (PANAS) is a self-report questionnaire to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much). Scores can range from 10-50 for both the Positive and Negative Affect with the lower scores representing lower levels of Positive/Negative Affect and higher scores representing higher levels of Positive/Negative Affect. The average value was estimated from Baseline to 8 months |
| Smoking Abstinence at 3 Months | Baseline to 3 months | Values represent change in probability of abstinence for unit change in emotional reactivity. Abstinence data collected using a timeline follow-back (TLFB) procedure. Continuous Abstinence was defined as no smoking within the last 4 weeks of treatment. It is scored as 0 if the participant smoked during the specific interval, and 1 if the participant abstained from smoking. |
| Measures of Smoking Satisfaction and Psychological Reward Using the Modified Cigarette Evaluation Questionnaire (mCEQ) Subscales | Baseline to 8 months | Modified Cigarette Evaluation Questionnaire (mCEQ). mCEQ Smoking satisfaction: range (1-21); mCEQ Psychological Reward: range(1-35); mCEQ Aversion: range (1-14); mCEQ Enjoyment of Resp.Tract Sens: range (1-7); mCEQ Craving Reduction: range (1-7). For all scales of mCEQ higher scores indicate worse outcomes (greater intensity of smoking effect). Scores of mCEQ Smoking satisfaction, mCEQ psychological reward and mCEQ aversion were summed to create the subscales. mCEQ Enjoyment of Resp Tract Sens and mCEQ Craving Reduction were single items. |
| Skin Conductance Response | Baseline to 1 month | Skin conductance response (SCR) amplitude measured by placing an electrodermal response transducer on the fore and ring fingers of the participants non-dominant hand, and heart rate (HR) was collected by placing a photoelectric pulse plethysmogram transducer on the middle finger of the participants non-dominant hand, during the presentation of emotionally valent stimuli (positive, negative, neutral, and smoking-related pictures). A single value was estimated by averaging within the specific time interval. |
| Heart Rate Response | Baseline to 1 month | Heart Rate Response. A single value was estimated by averaging within the specific time interval. During a quit attempt, smokers were evaluated on how they react to smoking related cues. An interaction term was then formed by the reactivity to smoking stimulus and genotype. |
| Symptoms of Depression Using the Center for Epidemiologic Studies Depression Scale (CES-D) | Baseline to 8 months | Symptoms of nicotine withdrawal measured using Center for Epidemiologic Studies Depression Scale (CES-D). Center of Epidemiologic Studies Depression Scale (CESD) a 20-item measure that asks caregivers to rate how often over the past week they experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms. The average value was estimated from Baseline to 8 months |
| Smoking Abstinence at 3 Months by DRD2 A1 Allele | Baseline to 3 Month | Values represent change in probability of abstinence for unit change in emotional reactivity. Abstinence data collected using a timeline follow-back (TLFB) procedure. Continuous Abstinence was defined as no smoking within the last 4 weeks of treatment. It is scored as 0 if the participant smoked during the specific interval, and 1 if the participant abstained from smoking. |
Countries
United States
Participant flow
Recruitment details
A total of 254 subjects were randomized (varenicline: 75; bupropion: 89; placebo: 90 between December 2005 through October 2010. All subjects were residing in the Greater Houston Area and the study was completed at UT MD Anderson Cancer Center.
Pre-assignment details
646 participants signed consent, 392 were screen failures
Participants by arm
| Arm | Count |
|---|---|
| Varenicline Varenicline starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter).
Varenicline: Starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter) | 75 |
| Bupropion Bupropion starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter).
Bupropion: Starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter) | 89 |
| Placebo Placebo by mouth for 12 weeks.
Placebo: Placebo by mouth for 12 weeks. | 90 |
| Total | 254 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| From 3 Months to 6 Months | Lost to Follow-up | 6 | 10 | 9 |
| Randomization to Month 3 | Lost to Follow-up | 15 | 14 | 20 |
Baseline characteristics
| Characteristic | Total | Placebo | Bupropion | Varenicline |
|---|---|---|---|---|
| Age, Continuous | 44.6 Years STANDARD_DEVIATION 10.35 | 45.7 Years STANDARD_DEVIATION 10.9 | 44.5 Years STANDARD_DEVIATION 9.3 | 43.5 Years STANDARD_DEVIATION 10.8 |
| Demographic and individual-level characteristics - (CESD) | 7.3 Score on a scale STANDARD_DEVIATION 6.5 | 8.1 Score on a scale STANDARD_DEVIATION 7.1 | 6.9 Score on a scale STANDARD_DEVIATION 6.1 | 6.7 Score on a scale STANDARD_DEVIATION 6.1 |
| Demographic and individual-level characteristics -Modified Cigarette Evaluation Questionnaire (mCEQ) mCEQ Aversion | 1.5 scores on a scale STANDARD_DEVIATION 0.8 | 1.5 scores on a scale STANDARD_DEVIATION 0.8 | 1.6 scores on a scale STANDARD_DEVIATION 0.7 | 1.6 scores on a scale STANDARD_DEVIATION 0.8 |
| Demographic and individual-level characteristics -Modified Cigarette Evaluation Questionnaire (mCEQ) mCEQ Craving Reduction | 5 scores on a scale STANDARD_DEVIATION 1.5 | 4.9 scores on a scale STANDARD_DEVIATION 1.6 | 5.1 scores on a scale STANDARD_DEVIATION 1.4 | 5.1 scores on a scale STANDARD_DEVIATION 1.5 |
| Demographic and individual-level characteristics -Modified Cigarette Evaluation Questionnaire (mCEQ) mCEQ Enjoyment of Respiratory Tract Sensation | 2.9 scores on a scale STANDARD_DEVIATION 1.5 | 2.9 scores on a scale STANDARD_DEVIATION 1.4 | 2.9 scores on a scale STANDARD_DEVIATION 1.4 | 2.9 scores on a scale STANDARD_DEVIATION 1.5 |
| Demographic and individual-level characteristics -Modified Cigarette Evaluation Questionnaire (mCEQ) mCEQ Psychological Reward | 3.8 scores on a scale STANDARD_DEVIATION 3.1 | 3.6 scores on a scale STANDARD_DEVIATION 1.3 | 3.7 scores on a scale STANDARD_DEVIATION 1.1 | 4.1 scores on a scale STANDARD_DEVIATION 4.9 |
| Demographic and individual-level characteristics -Modified Cigarette Evaluation Questionnaire (mCEQ) mCEQ Smoking Satisfaction | 4.2 scores on a scale STANDARD_DEVIATION 1.2 | 4.2 scores on a scale STANDARD_DEVIATION 1.2 | 3.9 scores on a scale STANDARD_DEVIATION 1.2 | 4.3 scores on a scale STANDARD_DEVIATION 1.1 |
| Demographic and individual-level characteristics -Positive and Negative Affect Scales (PANAS) PANAS Negative Affect | 15.6 Score on a scale STANDARD_DEVIATION 5.3 | 16.4 Score on a scale STANDARD_DEVIATION 5.9 | 15.6 Score on a scale STANDARD_DEVIATION 6.9 | 14.8 Score on a scale STANDARD_DEVIATION 5.1 |
| Demographic and individual-level characteristics -Positive and Negative Affect Scales (PANAS) PANAS Positive Affect | 35.9 Score on a scale STANDARD_DEVIATION 6.3 | 35.8 Score on a scale STANDARD_DEVIATION 6.2 | 36.1 Score on a scale STANDARD_DEVIATION 5.7 | 35.8 Score on a scale STANDARD_DEVIATION 7.1 |
| Demographic and individual-level characteristics Wisconsin Smoking Withdrawal Scale (WSWS) WSWS Anger Subscale | 4.1 Score on a scale STANDARD_DEVIATION 2.6 | 4.2 Score on a scale STANDARD_DEVIATION 7.9 | 4.2 Score on a scale STANDARD_DEVIATION 2.7 | 3.8 Score on a scale STANDARD_DEVIATION 2.6 |
| Demographic and individual-level characteristics Wisconsin Smoking Withdrawal Scale (WSWS) WSWS Anxiety Subscale | 7.5 Score on a scale STANDARD_DEVIATION 3.1 | 7.9 Score on a scale STANDARD_DEVIATION 3.3 | 7.3 Score on a scale STANDARD_DEVIATION 3.2 | 7.3 Score on a scale STANDARD_DEVIATION 2.7 |
| Demographic and individual-level characteristics Wisconsin Smoking Withdrawal Scale (WSWS) WSWS Concentration Subscale | 3.9 Score on a scale STANDARD_DEVIATION 2.1 | 3.9 Score on a scale STANDARD_DEVIATION 2.2 | 4 Score on a scale STANDARD_DEVIATION 2.2 | 3.7 Score on a scale STANDARD_DEVIATION 1.9 |
| Demographic and individual-level characteristics Wisconsin Smoking Withdrawal Scale (WSWS) WSWS Craving Subscale | 9.1 Score on a scale STANDARD_DEVIATION 2.8 | 9.1 Score on a scale STANDARD_DEVIATION 2.6 | 9.4 Score on a scale STANDARD_DEVIATION 2.8 | 8.7 Score on a scale STANDARD_DEVIATION 3.1 |
| Demographic and individual-level characteristics Wisconsin Smoking Withdrawal Scale (WSWS) WSWS Hunger Subscale | 10.2 Score on a scale STANDARD_DEVIATION 3.6 | 11.2 Score on a scale STANDARD_DEVIATION 3.7 | 9.8 Score on a scale STANDARD_DEVIATION 3.3 | 9.6 Score on a scale STANDARD_DEVIATION 3.7 |
| Demographic and individual-level characteristics Wisconsin Smoking Withdrawal Scale (WSWS) WSWS Sadness Subscale | 4.5 Score on a scale STANDARD_DEVIATION 2.8 | 4.7 Score on a scale STANDARD_DEVIATION 2.5 | 4.2 Score on a scale STANDARD_DEVIATION 2.4 | 4.6 Score on a scale STANDARD_DEVIATION 2.5 |
| Demographic and individual-level characteristics Wisconsin Smoking Withdrawal Scale (WSWS) WSWS Sleep Subscale | 8.6 Score on a scale STANDARD_DEVIATION 4.5 | 8.6 Score on a scale STANDARD_DEVIATION 4.4 | 9.3 Score on a scale STANDARD_DEVIATION 4.5 | 7.7 Score on a scale STANDARD_DEVIATION 4.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 24 Participants | 7 Participants | 6 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 225 Participants | 80 Participants | 82 Participants | 63 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants | 3 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 63 Participants | 22 Participants | 23 Participants | 18 Participants |
| Race (NIH/OMB) More than one race | 20 Participants | 6 Participants | 4 Participants | 10 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 2 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) White | 156 Participants | 60 Participants | 57 Participants | 39 Participants |
| Region of Enrollment United States | 254 participants | 90 participants | 89 participants | 75 participants |
| Sex: Female, Male Female | 98 Participants | 34 Participants | 34 Participants | 30 Participants |
| Sex: Female, Male Male | 156 Participants | 56 Participants | 55 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 75 | 0 / 89 | 0 / 90 |
| other Total, other adverse events | 63 / 75 | 69 / 89 | 66 / 90 |
| serious Total, serious adverse events | 2 / 75 | 2 / 89 | 0 / 90 |
Outcome results
Primary
Emotional Reactivity By Pharmacotherapy
Emotional reactivity measured by the peak eye blink electromyography (EMG) of the orbicularis oculi (ORB) muscle responses to acoustic startle probe delivered during the presentation of emotionally valent stimuli (pleasant, unpleasant, neutral, and smoking-related pictures). A single value was estimated by averaging within the specific time interval.
Time frame: Baseline to 1 month
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Varenicline | Emotional Reactivity By Pharmacotherapy | Emotional Reactivity (ORB) to Cigarette Stimuli | 66.6 microvolts |
| Varenicline | Emotional Reactivity By Pharmacotherapy | Emotional Reactivity (ORB) to Negative Stimuli | 70.9 microvolts |
| Varenicline | Emotional Reactivity By Pharmacotherapy | Emotional Reactivity (ORB) to Positive Stimuli | 66.7 microvolts |
| Varenicline | Emotional Reactivity By Pharmacotherapy | Emotional Reactivity (ORB) to Neutral Stimuli | 59.6 microvolts |
| Bupropion | Emotional Reactivity By Pharmacotherapy | Emotional Reactivity (ORB) to Neutral Stimuli | 64.9 microvolts |
| Bupropion | Emotional Reactivity By Pharmacotherapy | Emotional Reactivity (ORB) to Cigarette Stimuli | 64.7 microvolts |
| Bupropion | Emotional Reactivity By Pharmacotherapy | Emotional Reactivity (ORB) to Positive Stimuli | 65.4 microvolts |
| Bupropion | Emotional Reactivity By Pharmacotherapy | Emotional Reactivity (ORB) to Negative Stimuli | 73.1 microvolts |
| Placebo | Emotional Reactivity By Pharmacotherapy | Emotional Reactivity (ORB) to Neutral Stimuli | 72.5 microvolts |
| Placebo | Emotional Reactivity By Pharmacotherapy | Emotional Reactivity (ORB) to Negative Stimuli | 65.6 microvolts |
| Placebo | Emotional Reactivity By Pharmacotherapy | Emotional Reactivity (ORB) to Positive Stimuli | 64.7 microvolts |
| Placebo | Emotional Reactivity By Pharmacotherapy | Emotional Reactivity (ORB) to Cigarette Stimuli | 65.6 microvolts |
Primary
Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele
The emotional reactivity (ORB EMG) of smokers during cessation will be moderated by genotype. A single value was estimated by averaging within the specific time interval. During a quit attempt, smokers were evaluated on how they react to smoking related cues. An interaction term was then formed by the reactivity to smoking stimulus and genotype.
Time frame: Baseline to 1 month
Population: 13 participants had missing data in DRD2 A1 and were not included in the analysis. 1 participant was from the Varenicline group, 7 from the Buproprion group and 5 from the placebo group.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Varenicline | Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele | Emotional Reactivity (ORB) to Cigarette Stimuli | 66.5 microvolts |
| Varenicline | Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele | Emotional Reactivity (ORB) to Negative Stimuli | 70.5 microvolts |
| Varenicline | Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele | Emotional Reactivity (ORB) to Positive Stimuli | 65.5 microvolts |
| Varenicline | Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele | Emotional Reactivity (ORB) to Neutral Stimuli | 55.3 microvolts |
| Bupropion | Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele | Emotional Reactivity (ORB) to Neutral Stimuli | 67.2 microvolts |
| Bupropion | Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele | Emotional Reactivity (ORB) to Positive Stimuli | 72 microvolts |
| Bupropion | Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele | Emotional Reactivity (ORB) to Negative Stimuli | 75.1 microvolts |
| Bupropion | Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele | Emotional Reactivity (ORB) to Cigarette Stimuli | 69.9 microvolts |
| Placebo | Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele | Emotional Reactivity (ORB) to Neutral Stimuli | 73.9 microvolts |
| Placebo | Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele | Emotional Reactivity (ORB) to Negative Stimuli | 78.6 microvolts |
| Placebo | Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele | Emotional Reactivity (ORB) to Positive Stimuli | 71.3 microvolts |
| Placebo | Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele | Emotional Reactivity (ORB) to Cigarette Stimuli | 66.2 microvolts |
| Bupropion With DRD2 A1 Allele | Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele | Emotional Reactivity (ORB) to Cigarette Stimuli | 66 microvolts |
| Bupropion With DRD2 A1 Allele | Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele | Emotional Reactivity (ORB) to Neutral Stimuli | 61.2 microvolts |
| Bupropion With DRD2 A1 Allele | Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele | Emotional Reactivity (ORB) to Negative Stimuli | 71.3 microvolts |
| Bupropion With DRD2 A1 Allele | Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele | Emotional Reactivity (ORB) to Positive Stimuli | 63.3 microvolts |
| Placebo w/o DRD2 A1 Allele | Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele | Emotional Reactivity (ORB) to Positive Stimuli | 68.5 microvolts |
| Placebo w/o DRD2 A1 Allele | Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele | Emotional Reactivity (ORB) to Neutral Stimuli | 79.7 microvolts |
| Placebo w/o DRD2 A1 Allele | Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele | Emotional Reactivity (ORB) to Cigarette Stimuli | 67.3 microvolts |
| Placebo w/o DRD2 A1 Allele | Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele | Emotional Reactivity (ORB) to Negative Stimuli | 74 microvolts |
| Placebo With DRD2 A1 Allele | Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele | Emotional Reactivity (ORB) to Negative Stimuli | 68.1 microvolts |
| Placebo With DRD2 A1 Allele | Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele | Emotional Reactivity (ORB) to Positive Stimuli | 63.8 microvolts |
| Placebo With DRD2 A1 Allele | Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele | Emotional Reactivity (ORB) to Neutral Stimuli | 67.8 microvolts |
| Placebo With DRD2 A1 Allele | Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele | Emotional Reactivity (ORB) to Cigarette Stimuli | 68.1 microvolts |
Secondary
Abstinence at 6 Months by DRD2 A1 Allele
Values represent change in probability of abstinence for unit change in emotional reactivity. Abstinence data collected using a timeline follow-back (TLFB) procedure. Continuous Abstinence was defined as no smoking within the last 4 weeks of treatment. It is scored as 0 if the participant smoked during the specific interval, and 1 if the participant abstained from smoking.
Time frame: Baseline to 6 Month ( the effects shown are the increase/decrease in probability of abstinence for 1 unit increase in the predictor)
Population: 13 participants had missing data in DRD2 A1 and were not included in the analysis. 1 participant was from the Varenicline group, 7 from the Buproprion group and 5 from the placebo group.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Varenicline | Abstinence at 6 Months by DRD2 A1 Allele | Emotional Reactivity (ORB) to Positive Stimuli | 0.003 probability |
| Varenicline | Abstinence at 6 Months by DRD2 A1 Allele | Emotional Reactivity (ORB) to Negative Stimuli | 0.003 probability |
| Varenicline | Abstinence at 6 Months by DRD2 A1 Allele | Emotional Reactivity (ORB) to Neutral Stimuli | 0.003 probability |
| Varenicline | Abstinence at 6 Months by DRD2 A1 Allele | Emotional Reactivity (ORB) to Cigarette Stimuli | 0.003 probability |
| Bupropion | Abstinence at 6 Months by DRD2 A1 Allele | Emotional Reactivity (ORB) to Negative Stimuli | -0.001 probability |
| Bupropion | Abstinence at 6 Months by DRD2 A1 Allele | Emotional Reactivity (ORB) to Cigarette Stimuli | -0.001 probability |
| Bupropion | Abstinence at 6 Months by DRD2 A1 Allele | Emotional Reactivity (ORB) to Neutral Stimuli | -0.001 probability |
| Bupropion | Abstinence at 6 Months by DRD2 A1 Allele | Emotional Reactivity (ORB) to Positive Stimuli | 0 probability |
| Placebo | Abstinence at 6 Months by DRD2 A1 Allele | Emotional Reactivity (ORB) to Positive Stimuli | 0 probability |
| Placebo | Abstinence at 6 Months by DRD2 A1 Allele | Emotional Reactivity (ORB) to Cigarette Stimuli | 0.001 probability |
| Placebo | Abstinence at 6 Months by DRD2 A1 Allele | Emotional Reactivity (ORB) to Negative Stimuli | 0.001 probability |
| Placebo | Abstinence at 6 Months by DRD2 A1 Allele | Emotional Reactivity (ORB) to Neutral Stimuli | 0.001 probability |
| Bupropion With DRD2 A1 Allele | Abstinence at 6 Months by DRD2 A1 Allele | Emotional Reactivity (ORB) to Cigarette Stimuli | -0.001 probability |
| Bupropion With DRD2 A1 Allele | Abstinence at 6 Months by DRD2 A1 Allele | Emotional Reactivity (ORB) to Negative Stimuli | -0.002 probability |
| Bupropion With DRD2 A1 Allele | Abstinence at 6 Months by DRD2 A1 Allele | Emotional Reactivity (ORB) to Positive Stimuli | -0.001 probability |
| Bupropion With DRD2 A1 Allele | Abstinence at 6 Months by DRD2 A1 Allele | Emotional Reactivity (ORB) to Neutral Stimuli | -0.001 probability |
| Placebo w/o DRD2 A1 Allele | Abstinence at 6 Months by DRD2 A1 Allele | Emotional Reactivity (ORB) to Cigarette Stimuli | 0 probability |
| Placebo w/o DRD2 A1 Allele | Abstinence at 6 Months by DRD2 A1 Allele | Emotional Reactivity (ORB) to Negative Stimuli | 0 probability |
| Placebo w/o DRD2 A1 Allele | Abstinence at 6 Months by DRD2 A1 Allele | Emotional Reactivity (ORB) to Neutral Stimuli | 0 probability |
| Placebo w/o DRD2 A1 Allele | Abstinence at 6 Months by DRD2 A1 Allele | Emotional Reactivity (ORB) to Positive Stimuli | 0 probability |
| Placebo With DRD2 A1 Allele | Abstinence at 6 Months by DRD2 A1 Allele | Emotional Reactivity (ORB) to Positive Stimuli | -0.004 probability |
| Placebo With DRD2 A1 Allele | Abstinence at 6 Months by DRD2 A1 Allele | Emotional Reactivity (ORB) to Negative Stimuli | -0.004 probability |
| Placebo With DRD2 A1 Allele | Abstinence at 6 Months by DRD2 A1 Allele | Emotional Reactivity (ORB) to Cigarette Stimuli | -0.005 probability |
| Placebo With DRD2 A1 Allele | Abstinence at 6 Months by DRD2 A1 Allele | Emotional Reactivity (ORB) to Neutral Stimuli | -0.004 probability |
Secondary
Heart Rate Response
Heart Rate Response. A single value was estimated by averaging within the specific time interval. During a quit attempt, smokers were evaluated on how they react to smoking related cues. An interaction term was then formed by the reactivity to smoking stimulus and genotype.
Time frame: Baseline to 1 month
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Varenicline | Heart Rate Response | Heart Rate response to Cigarette Stimuli | 69.731 beats per minute |
| Varenicline | Heart Rate Response | Heart Rate response to Negative Stimuli | 69.562 beats per minute |
| Varenicline | Heart Rate Response | Heart Rate response to Positive Stimuli | 69.151 beats per minute |
| Varenicline | Heart Rate Response | Heart Rate response to Neutral Stimuli | 69.621 beats per minute |
| Bupropion | Heart Rate Response | Heart Rate response to Positive Stimuli | 68.711 beats per minute |
| Bupropion | Heart Rate Response | Heart Rate response to Negative Stimuli | 68.078 beats per minute |
| Bupropion | Heart Rate Response | Heart Rate response to Cigarette Stimuli | 68.652 beats per minute |
| Bupropion | Heart Rate Response | Heart Rate response to Neutral Stimuli | 68.969 beats per minute |
| Placebo | Heart Rate Response | Heart Rate response to Neutral Stimuli | 71.706 beats per minute |
| Placebo | Heart Rate Response | Heart Rate response to Positive Stimuli | 71.518 beats per minute |
| Placebo | Heart Rate Response | Heart Rate response to Negative Stimuli | 71.077 beats per minute |
| Placebo | Heart Rate Response | Heart Rate response to Cigarette Stimuli | 71.427 beats per minute |
| Bupropion With DRD2 A1 Allele | Heart Rate Response | Heart Rate response to Cigarette Stimuli | 69.836 beats per minute |
| Bupropion With DRD2 A1 Allele | Heart Rate Response | Heart Rate response to Neutral Stimuli | 70.234 beats per minute |
| Bupropion With DRD2 A1 Allele | Heart Rate Response | Heart Rate response to Negative Stimuli | 69.595 beats per minute |
| Bupropion With DRD2 A1 Allele | Heart Rate Response | Heart Rate response to Positive Stimuli | 70.404 beats per minute |
| Placebo w/o DRD2 A1 Allele | Heart Rate Response | Heart Rate response to Positive Stimuli | 65.787 beats per minute |
| Placebo w/o DRD2 A1 Allele | Heart Rate Response | Heart Rate response to Neutral Stimuli | 65.237 beats per minute |
| Placebo w/o DRD2 A1 Allele | Heart Rate Response | Heart Rate response to Negative Stimuli | 65.768 beats per minute |
| Placebo w/o DRD2 A1 Allele | Heart Rate Response | Heart Rate response to Cigarette Stimuli | 65.966 beats per minute |
| Placebo With DRD2 A1 Allele | Heart Rate Response | Heart Rate response to Negative Stimuli | 65.569 beats per minute |
| Placebo With DRD2 A1 Allele | Heart Rate Response | Heart Rate response to Positive Stimuli | 65.927 beats per minute |
| Placebo With DRD2 A1 Allele | Heart Rate Response | Heart Rate response to Neutral Stimuli | 66.04 beats per minute |
| Placebo With DRD2 A1 Allele | Heart Rate Response | Heart Rate response to Cigarette Stimuli | 65.276 beats per minute |
Secondary
Measures of Smoking Satisfaction and Psychological Reward Using the Modified Cigarette Evaluation Questionnaire (mCEQ) Subscales
Modified Cigarette Evaluation Questionnaire (mCEQ). mCEQ Smoking satisfaction: range (1-21); mCEQ Psychological Reward: range(1-35); mCEQ Aversion: range (1-14); mCEQ Enjoyment of Resp.Tract Sens: range (1-7); mCEQ Craving Reduction: range (1-7). For all scales of mCEQ higher scores indicate worse outcomes (greater intensity of smoking effect). Scores of mCEQ Smoking satisfaction, mCEQ psychological reward and mCEQ aversion were summed to create the subscales. mCEQ Enjoyment of Resp Tract Sens and mCEQ Craving Reduction were single items.
Time frame: Baseline to 8 months
Population: 13 participants had missing data in DRD2 A1 and were not included in the analysis. 1 participant was from the Varenicline group, 7 from the Buproprion group and 5 from the placebo group.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Varenicline | Measures of Smoking Satisfaction and Psychological Reward Using the Modified Cigarette Evaluation Questionnaire (mCEQ) Subscales | Psychological Reward | 2.819 score on a scale |
| Varenicline | Measures of Smoking Satisfaction and Psychological Reward Using the Modified Cigarette Evaluation Questionnaire (mCEQ) Subscales | Enjoyment of Respiratory Tract Sensation | 1.912 score on a scale |
| Varenicline | Measures of Smoking Satisfaction and Psychological Reward Using the Modified Cigarette Evaluation Questionnaire (mCEQ) Subscales | Aversion | 1.612 score on a scale |
| Varenicline | Measures of Smoking Satisfaction and Psychological Reward Using the Modified Cigarette Evaluation Questionnaire (mCEQ) Subscales | Craving Reduction | 4.531 score on a scale |
| Varenicline | Measures of Smoking Satisfaction and Psychological Reward Using the Modified Cigarette Evaluation Questionnaire (mCEQ) Subscales | Smoking Satisfaction | 2.895 score on a scale |
| Bupropion | Measures of Smoking Satisfaction and Psychological Reward Using the Modified Cigarette Evaluation Questionnaire (mCEQ) Subscales | Enjoyment of Respiratory Tract Sensation | 1.703 score on a scale |
| Bupropion | Measures of Smoking Satisfaction and Psychological Reward Using the Modified Cigarette Evaluation Questionnaire (mCEQ) Subscales | Craving Reduction | 3.952 score on a scale |
| Bupropion | Measures of Smoking Satisfaction and Psychological Reward Using the Modified Cigarette Evaluation Questionnaire (mCEQ) Subscales | Psychological Reward | 2.155 score on a scale |
| Bupropion | Measures of Smoking Satisfaction and Psychological Reward Using the Modified Cigarette Evaluation Questionnaire (mCEQ) Subscales | Aversion | 1.694 score on a scale |
| Bupropion | Measures of Smoking Satisfaction and Psychological Reward Using the Modified Cigarette Evaluation Questionnaire (mCEQ) Subscales | Smoking Satisfaction | 2.591 score on a scale |
| Placebo | Measures of Smoking Satisfaction and Psychological Reward Using the Modified Cigarette Evaluation Questionnaire (mCEQ) Subscales | Aversion | 1.988 score on a scale |
| Placebo | Measures of Smoking Satisfaction and Psychological Reward Using the Modified Cigarette Evaluation Questionnaire (mCEQ) Subscales | Craving Reduction | 4.564 score on a scale |
| Placebo | Measures of Smoking Satisfaction and Psychological Reward Using the Modified Cigarette Evaluation Questionnaire (mCEQ) Subscales | Smoking Satisfaction | 4.064 score on a scale |
| Placebo | Measures of Smoking Satisfaction and Psychological Reward Using the Modified Cigarette Evaluation Questionnaire (mCEQ) Subscales | Psychological Reward | 2.519 score on a scale |
| Placebo | Measures of Smoking Satisfaction and Psychological Reward Using the Modified Cigarette Evaluation Questionnaire (mCEQ) Subscales | Enjoyment of Respiratory Tract Sensation | 4.096 score on a scale |
| Bupropion With DRD2 A1 Allele | Measures of Smoking Satisfaction and Psychological Reward Using the Modified Cigarette Evaluation Questionnaire (mCEQ) Subscales | Smoking Satisfaction | 3.369 score on a scale |
| Bupropion With DRD2 A1 Allele | Measures of Smoking Satisfaction and Psychological Reward Using the Modified Cigarette Evaluation Questionnaire (mCEQ) Subscales | Enjoyment of Respiratory Tract Sensation | 1.955 score on a scale |
| Bupropion With DRD2 A1 Allele | Measures of Smoking Satisfaction and Psychological Reward Using the Modified Cigarette Evaluation Questionnaire (mCEQ) Subscales | Aversion | 1.79 score on a scale |
| Bupropion With DRD2 A1 Allele | Measures of Smoking Satisfaction and Psychological Reward Using the Modified Cigarette Evaluation Questionnaire (mCEQ) Subscales | Craving Reduction | 6.628 score on a scale |
| Bupropion With DRD2 A1 Allele | Measures of Smoking Satisfaction and Psychological Reward Using the Modified Cigarette Evaluation Questionnaire (mCEQ) Subscales | Psychological Reward | 2.723 score on a scale |
| Placebo w/o DRD2 A1 Allele | Measures of Smoking Satisfaction and Psychological Reward Using the Modified Cigarette Evaluation Questionnaire (mCEQ) Subscales | Psychological Reward | 3.575 score on a scale |
| Placebo w/o DRD2 A1 Allele | Measures of Smoking Satisfaction and Psychological Reward Using the Modified Cigarette Evaluation Questionnaire (mCEQ) Subscales | Aversion | 1.808 score on a scale |
| Placebo w/o DRD2 A1 Allele | Measures of Smoking Satisfaction and Psychological Reward Using the Modified Cigarette Evaluation Questionnaire (mCEQ) Subscales | Enjoyment of Respiratory Tract Sensation | 3.711 score on a scale |
| Placebo w/o DRD2 A1 Allele | Measures of Smoking Satisfaction and Psychological Reward Using the Modified Cigarette Evaluation Questionnaire (mCEQ) Subscales | Smoking Satisfaction | 3.025 score on a scale |
| Placebo w/o DRD2 A1 Allele | Measures of Smoking Satisfaction and Psychological Reward Using the Modified Cigarette Evaluation Questionnaire (mCEQ) Subscales | Craving Reduction | 4.486 score on a scale |
| Placebo With DRD2 A1 Allele | Measures of Smoking Satisfaction and Psychological Reward Using the Modified Cigarette Evaluation Questionnaire (mCEQ) Subscales | Psychological Reward | 3.246 score on a scale |
| Placebo With DRD2 A1 Allele | Measures of Smoking Satisfaction and Psychological Reward Using the Modified Cigarette Evaluation Questionnaire (mCEQ) Subscales | Smoking Satisfaction | 3.515 score on a scale |
| Placebo With DRD2 A1 Allele | Measures of Smoking Satisfaction and Psychological Reward Using the Modified Cigarette Evaluation Questionnaire (mCEQ) Subscales | Craving Reduction | 4.673 score on a scale |
| Placebo With DRD2 A1 Allele | Measures of Smoking Satisfaction and Psychological Reward Using the Modified Cigarette Evaluation Questionnaire (mCEQ) Subscales | Aversion | 1.69 score on a scale |
| Placebo With DRD2 A1 Allele | Measures of Smoking Satisfaction and Psychological Reward Using the Modified Cigarette Evaluation Questionnaire (mCEQ) Subscales | Enjoyment of Respiratory Tract Sensation | 2.783 score on a scale |
Secondary
Skin Conductance Response
Skin conductance response (SCR) amplitude measured by placing an electrodermal response transducer on the fore and ring fingers of the participants non-dominant hand, and heart rate (HR) was collected by placing a photoelectric pulse plethysmogram transducer on the middle finger of the participants non-dominant hand, during the presentation of emotionally valent stimuli (positive, negative, neutral, and smoking-related pictures). A single value was estimated by averaging within the specific time interval.
Time frame: Baseline to 1 month
Population: 13 participants had missing data in DRD2 A1 and were not included in the analysis. 1 participant was from the Varenicline group, 7 from the Buproprion group and 5 from the placebo group.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Varenicline | Skin Conductance Response | Skin conductance to Negative Stimuli | 2.295 Microsiemens |
| Varenicline | Skin Conductance Response | Skin conductance to Positive Stimuli | 2.256 Microsiemens |
| Varenicline | Skin Conductance Response | Skin conductance to Cigarette Stimuli | 2.301 Microsiemens |
| Varenicline | Skin Conductance Response | Skin conductance to Neutral Stimuli | 2.261 Microsiemens |
| Bupropion | Skin Conductance Response | Skin conductance to Neutral Stimuli | 2.017 Microsiemens |
| Bupropion | Skin Conductance Response | Skin conductance to Negative Stimuli | 1.969 Microsiemens |
| Bupropion | Skin Conductance Response | Skin conductance to Cigarette Stimuli | 2.016 Microsiemens |
| Bupropion | Skin Conductance Response | Skin conductance to Positive Stimuli | 1.984 Microsiemens |
| Placebo | Skin Conductance Response | Skin conductance to Positive Stimuli | 2.299 Microsiemens |
| Placebo | Skin Conductance Response | Skin conductance to Cigarette Stimuli | 2.275 Microsiemens |
| Placebo | Skin Conductance Response | Skin conductance to Neutral Stimuli | 2.369 Microsiemens |
| Placebo | Skin Conductance Response | Skin conductance to Negative Stimuli | 2.31 Microsiemens |
| Bupropion With DRD2 A1 Allele | Skin Conductance Response | Skin conductance to Negative Stimuli | 1.695 Microsiemens |
| Bupropion With DRD2 A1 Allele | Skin Conductance Response | Skin conductance to Neutral Stimuli | 1.699 Microsiemens |
| Bupropion With DRD2 A1 Allele | Skin Conductance Response | Skin conductance to Cigarette Stimuli | 1.797 Microsiemens |
| Bupropion With DRD2 A1 Allele | Skin Conductance Response | Skin conductance to Positive Stimuli | 1.7 Microsiemens |
| Placebo w/o DRD2 A1 Allele | Skin Conductance Response | Skin conductance to Negative Stimuli | 2.355 Microsiemens |
| Placebo w/o DRD2 A1 Allele | Skin Conductance Response | Skin conductance to Cigarette Stimuli | 2.272 Microsiemens |
| Placebo w/o DRD2 A1 Allele | Skin Conductance Response | Skin conductance to Positive Stimuli | 2.296 Microsiemens |
| Placebo w/o DRD2 A1 Allele | Skin Conductance Response | Skin conductance to Neutral Stimuli | 2.362 Microsiemens |
| Placebo With DRD2 A1 Allele | Skin Conductance Response | Skin conductance to Negative Stimuli | 2.485 Microsiemens |
| Placebo With DRD2 A1 Allele | Skin Conductance Response | Skin conductance to Cigarette Stimuli | 2.443 Microsiemens |
| Placebo With DRD2 A1 Allele | Skin Conductance Response | Skin conductance to Neutral Stimuli | 2.559 Microsiemens |
| Placebo With DRD2 A1 Allele | Skin Conductance Response | Skin conductance to Positive Stimuli | 2.565 Microsiemens |
Secondary
Smoking Abstinence at 3 Months
Values represent change in probability of abstinence for unit change in emotional reactivity. Abstinence data collected using a timeline follow-back (TLFB) procedure. Continuous Abstinence was defined as no smoking within the last 4 weeks of treatment. It is scored as 0 if the participant smoked during the specific interval, and 1 if the participant abstained from smoking.
Time frame: Baseline to 3 months
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Varenicline | Smoking Abstinence at 3 Months | Emotional Reactivity (ORB) to Neutral Stimuli | -0.004 probability |
| Varenicline | Smoking Abstinence at 3 Months | Emotional Reactivity (ORB) to Negative Stimuli | -0.004 probability |
| Varenicline | Smoking Abstinence at 3 Months | Emotional Reactivity (ORB) to Cigarette Stimuli | -0.003 probability |
| Varenicline | Smoking Abstinence at 3 Months | Emotional Reactivity (ORB) to Positive Stimuli | -0.003 probability |
| Bupropion | Smoking Abstinence at 3 Months | Emotional Reactivity (ORB) to Positive Stimuli | -0.01 probability |
| Bupropion | Smoking Abstinence at 3 Months | Emotional Reactivity (ORB) to Neutral Stimuli | -0.008 probability |
| Bupropion | Smoking Abstinence at 3 Months | Emotional Reactivity (ORB) to Cigarette Stimuli | -0.01 probability |
| Bupropion | Smoking Abstinence at 3 Months | Emotional Reactivity (ORB) to Negative Stimuli | -0.009 probability |
| Placebo | Smoking Abstinence at 3 Months | Emotional Reactivity (ORB) to Neutral Stimuli | -0.007 probability |
| Placebo | Smoking Abstinence at 3 Months | Emotional Reactivity (ORB) to Positive Stimuli | -0.007 probability |
| Placebo | Smoking Abstinence at 3 Months | Emotional Reactivity (ORB) to Negative Stimuli | -0.007 probability |
| Placebo | Smoking Abstinence at 3 Months | Emotional Reactivity (ORB) to Cigarette Stimuli | -0.008 probability |
Secondary
Smoking Abstinence at 3 Months by DRD2 A1 Allele
Values represent change in probability of abstinence for unit change in emotional reactivity. Abstinence data collected using a timeline follow-back (TLFB) procedure. Continuous Abstinence was defined as no smoking within the last 4 weeks of treatment. It is scored as 0 if the participant smoked during the specific interval, and 1 if the participant abstained from smoking.
Time frame: Baseline to 3 Month
Population: 13 participants had missing data in DRD2 A1 and were not included in the analysis. 1 participant was from the Varenicline group, 7 from the Buproprion group and 5 from the placebo group.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Varenicline | Smoking Abstinence at 3 Months by DRD2 A1 Allele | Emotional Reactivity (ORB) to Negative Stimuli | 0.002 probability |
| Varenicline | Smoking Abstinence at 3 Months by DRD2 A1 Allele | Emotional Reactivity (ORB) to Cigarette Stimuli | 0.001 probability |
| Varenicline | Smoking Abstinence at 3 Months by DRD2 A1 Allele | Emotional Reactivity (ORB) to Positive Stimuli | 0.001 probability |
| Varenicline | Smoking Abstinence at 3 Months by DRD2 A1 Allele | Emotional Reactivity (ORB) to Neutral Stimuli | 0.001 probability |
| Bupropion | Smoking Abstinence at 3 Months by DRD2 A1 Allele | Emotional Reactivity (ORB) to Cigarette Stimuli | -0.004 probability |
| Bupropion | Smoking Abstinence at 3 Months by DRD2 A1 Allele | Emotional Reactivity (ORB) to Positive Stimuli | -0.005 probability |
| Bupropion | Smoking Abstinence at 3 Months by DRD2 A1 Allele | Emotional Reactivity (ORB) to Neutral Stimuli | -0.005 probability |
| Bupropion | Smoking Abstinence at 3 Months by DRD2 A1 Allele | Emotional Reactivity (ORB) to Negative Stimuli | -0.005 probability |
| Placebo | Smoking Abstinence at 3 Months by DRD2 A1 Allele | Emotional Reactivity (ORB) to Cigarette Stimuli | 0 probability |
| Placebo | Smoking Abstinence at 3 Months by DRD2 A1 Allele | Emotional Reactivity (ORB) to Negative Stimuli | 0 probability |
| Placebo | Smoking Abstinence at 3 Months by DRD2 A1 Allele | Emotional Reactivity (ORB) to Positive Stimuli | 0 probability |
| Placebo | Smoking Abstinence at 3 Months by DRD2 A1 Allele | Emotional Reactivity (ORB) to Neutral Stimuli | 0.001 probability |
| Bupropion With DRD2 A1 Allele | Smoking Abstinence at 3 Months by DRD2 A1 Allele | Emotional Reactivity (ORB) to Cigarette Stimuli | -0.003 probability |
| Bupropion With DRD2 A1 Allele | Smoking Abstinence at 3 Months by DRD2 A1 Allele | Emotional Reactivity (ORB) to Neutral Stimuli | -0.002 probability |
| Bupropion With DRD2 A1 Allele | Smoking Abstinence at 3 Months by DRD2 A1 Allele | Emotional Reactivity (ORB) to Negative Stimuli | -0.004 probability |
| Bupropion With DRD2 A1 Allele | Smoking Abstinence at 3 Months by DRD2 A1 Allele | Emotional Reactivity (ORB) to Positive Stimuli | -0.003 probability |
| Placebo w/o DRD2 A1 Allele | Smoking Abstinence at 3 Months by DRD2 A1 Allele | Emotional Reactivity (ORB) to Positive Stimuli | -0.001 probability |
| Placebo w/o DRD2 A1 Allele | Smoking Abstinence at 3 Months by DRD2 A1 Allele | Emotional Reactivity (ORB) to Cigarette Stimuli | -0.001 probability |
| Placebo w/o DRD2 A1 Allele | Smoking Abstinence at 3 Months by DRD2 A1 Allele | Emotional Reactivity (ORB) to Negative Stimuli | -0.001 probability |
| Placebo w/o DRD2 A1 Allele | Smoking Abstinence at 3 Months by DRD2 A1 Allele | Emotional Reactivity (ORB) to Neutral Stimuli | -0.001 probability |
| Placebo With DRD2 A1 Allele | Smoking Abstinence at 3 Months by DRD2 A1 Allele | Emotional Reactivity (ORB) to Negative Stimuli | -0.004 probability |
| Placebo With DRD2 A1 Allele | Smoking Abstinence at 3 Months by DRD2 A1 Allele | Emotional Reactivity (ORB) to Positive Stimuli | -0.004 probability |
| Placebo With DRD2 A1 Allele | Smoking Abstinence at 3 Months by DRD2 A1 Allele | Emotional Reactivity (ORB) to Neutral Stimuli | -0.003 probability |
| Placebo With DRD2 A1 Allele | Smoking Abstinence at 3 Months by DRD2 A1 Allele | Emotional Reactivity (ORB) to Cigarette Stimuli | -0.004 probability |
Secondary
Smoking Abstinence at 6 Months
Values represent change in probability of abstinence for unit change in emotional reactivity. Abstinence data collected using a timeline follow-back (TLFB) procedure. Continuous Abstinence was defined as no smoking within the last 4 weeks of treatment. It is scored as 0 if the participant smoked during the specific interval, and 1 if the participant abstained from smoking.
Time frame: Abstinence at 6 Months ( the effects shown are the increase/decrease in probability of abstinence for 1 unit increase in the predictor)
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Varenicline | Smoking Abstinence at 6 Months | Emotional Reactivity (ORB) to Cigaretee Stimuli | 0.007 probability |
| Varenicline | Smoking Abstinence at 6 Months | Emotional Reactivity (ORB) to Positive Stimuli | 0.01 probability |
| Varenicline | Smoking Abstinence at 6 Months | Emotional Reactivity (ORB) to Neutral Stimuli | 0.008 probability |
| Varenicline | Smoking Abstinence at 6 Months | Emotional Reactivity (ORB) to Negative Stimuli | 0.008 probability |
| Bupropion | Smoking Abstinence at 6 Months | Emotional Reactivity (ORB) to Cigaretee Stimuli | -0.002 probability |
| Bupropion | Smoking Abstinence at 6 Months | Emotional Reactivity (ORB) to Negative Stimuli | -0.003 probability |
| Bupropion | Smoking Abstinence at 6 Months | Emotional Reactivity (ORB) to Positive Stimuli | -0.003 probability |
| Bupropion | Smoking Abstinence at 6 Months | Emotional Reactivity (ORB) to Neutral Stimuli | -0.001 probability |
| Placebo | Smoking Abstinence at 6 Months | Emotional Reactivity (ORB) to Positive Stimuli | -0.005 probability |
| Placebo | Smoking Abstinence at 6 Months | Emotional Reactivity (ORB) to Cigaretee Stimuli | -0.006 probability |
| Placebo | Smoking Abstinence at 6 Months | Emotional Reactivity (ORB) to Negative Stimuli | -0.005 probability |
| Placebo | Smoking Abstinence at 6 Months | Emotional Reactivity (ORB) to Neutral Stimuli | -0.005 probability |
Secondary
Symptoms of Depression Using the Center for Epidemiologic Studies Depression Scale (CES-D)
Symptoms of nicotine withdrawal measured using Center for Epidemiologic Studies Depression Scale (CES-D). Center of Epidemiologic Studies Depression Scale (CESD) a 20-item measure that asks caregivers to rate how often over the past week they experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms. The average value was estimated from Baseline to 8 months
Time frame: Baseline to 8 months
Population: 13 participants had missing data in DRD2 A1 and were not included in the analysis. 1 participant was from the Varenicline group, 7 from the Buproprion group and 5 from the placebo group.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Varenicline | Symptoms of Depression Using the Center for Epidemiologic Studies Depression Scale (CES-D) | 8.084 score on a scale |
| Bupropion | Symptoms of Depression Using the Center for Epidemiologic Studies Depression Scale (CES-D) | 6.847 score on a scale |
| Placebo | Symptoms of Depression Using the Center for Epidemiologic Studies Depression Scale (CES-D) | 7.588 score on a scale |
| Bupropion With DRD2 A1 Allele | Symptoms of Depression Using the Center for Epidemiologic Studies Depression Scale (CES-D) | 8.362 score on a scale |
| Placebo w/o DRD2 A1 Allele | Symptoms of Depression Using the Center for Epidemiologic Studies Depression Scale (CES-D) | 8.65 score on a scale |
| Placebo With DRD2 A1 Allele | Symptoms of Depression Using the Center for Epidemiologic Studies Depression Scale (CES-D) | 10.799 score on a scale |
Secondary
Symptoms of Nicotine Withdrawal and Negative Affect Using Positive and Negative Affect Scale (PANAS)
Symptoms of nicotine withdrawal and negative affect were measured using the Positive and Negative Affect Scale (PANAS). The Positive and Negative Affect Schedule (PANAS) is a self-report questionnaire to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much). Scores can range from 10-50 for both the Positive and Negative Affect with the lower scores representing lower levels of Positive/Negative Affect and higher scores representing higher levels of Positive/Negative Affect. The average value was estimated from Baseline to 8 months
Time frame: Baseline to 8 months
Population: 13 participants had missing data in DRD2 A1 and were not included in the analysis. 1 participant was from the Varenicline group, 7 from the Buproprion group and 5 from the placebo group.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Varenicline | Symptoms of Nicotine Withdrawal and Negative Affect Using Positive and Negative Affect Scale (PANAS) | Positive Affect | 35.507 score on a scale |
| Varenicline | Symptoms of Nicotine Withdrawal and Negative Affect Using Positive and Negative Affect Scale (PANAS) | Negative Affect | 15.93 score on a scale |
| Bupropion | Symptoms of Nicotine Withdrawal and Negative Affect Using Positive and Negative Affect Scale (PANAS) | Positive Affect | 37.315 score on a scale |
| Bupropion | Symptoms of Nicotine Withdrawal and Negative Affect Using Positive and Negative Affect Scale (PANAS) | Negative Affect | 14.98 score on a scale |
| Placebo | Symptoms of Nicotine Withdrawal and Negative Affect Using Positive and Negative Affect Scale (PANAS) | Positive Affect | 36.429 score on a scale |
| Placebo | Symptoms of Nicotine Withdrawal and Negative Affect Using Positive and Negative Affect Scale (PANAS) | Negative Affect | 15.782 score on a scale |
| Bupropion With DRD2 A1 Allele | Symptoms of Nicotine Withdrawal and Negative Affect Using Positive and Negative Affect Scale (PANAS) | Positive Affect | 35.281 score on a scale |
| Bupropion With DRD2 A1 Allele | Symptoms of Nicotine Withdrawal and Negative Affect Using Positive and Negative Affect Scale (PANAS) | Negative Affect | 16.385 score on a scale |
| Placebo w/o DRD2 A1 Allele | Symptoms of Nicotine Withdrawal and Negative Affect Using Positive and Negative Affect Scale (PANAS) | Positive Affect | 33.672 score on a scale |
| Placebo w/o DRD2 A1 Allele | Symptoms of Nicotine Withdrawal and Negative Affect Using Positive and Negative Affect Scale (PANAS) | Negative Affect | 18.017 score on a scale |
| Placebo With DRD2 A1 Allele | Symptoms of Nicotine Withdrawal and Negative Affect Using Positive and Negative Affect Scale (PANAS) | Positive Affect | 33.984 score on a scale |
| Placebo With DRD2 A1 Allele | Symptoms of Nicotine Withdrawal and Negative Affect Using Positive and Negative Affect Scale (PANAS) | Negative Affect | 18.902 score on a scale |
Secondary
Symptoms of Nicotine Withdrawal Using the Wisconsin Smoking Withdrawal Scale (WSWS)
Symptoms of nicotine withdrawal measured using Wisconsin Smoking Withdrawal Scale (WSWS). The Wisconsin Withdrawal Scale (WSWS) contains 7 factors: Anger, Anxiety, Sadness, Concentration, Craving, Sleep, and Hunger. WSWS consists of 28 items that are scored on a 5-point Likert type scale (0 = strongly disagree, 4 = strongly agree). A single value was estimated by averaging within the specific time interval. Higher values represent worse outcome. The average value was estimated from Baseline to 8 months
Time frame: Baseline to 8 months
Population: 13 participants had missing data in DRD2 A1 and were not included in the analysis. 1 participant was from the Varenicline group, 7 from the Buproprion group and 5 from the placebo group.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Varenicline | Symptoms of Nicotine Withdrawal Using the Wisconsin Smoking Withdrawal Scale (WSWS) | Hunger | 11.016 score on a scale |
| Varenicline | Symptoms of Nicotine Withdrawal Using the Wisconsin Smoking Withdrawal Scale (WSWS) | Concentration | 3.743 score on a scale |
| Varenicline | Symptoms of Nicotine Withdrawal Using the Wisconsin Smoking Withdrawal Scale (WSWS) | Anxiety | 6.218 score on a scale |
| Varenicline | Symptoms of Nicotine Withdrawal Using the Wisconsin Smoking Withdrawal Scale (WSWS) | Sadness | 4.246 score on a scale |
| Varenicline | Symptoms of Nicotine Withdrawal Using the Wisconsin Smoking Withdrawal Scale (WSWS) | Sleep | 7.721 score on a scale |
| Varenicline | Symptoms of Nicotine Withdrawal Using the Wisconsin Smoking Withdrawal Scale (WSWS) | Craving | 6.646 score on a scale |
| Varenicline | Symptoms of Nicotine Withdrawal Using the Wisconsin Smoking Withdrawal Scale (WSWS) | Anger | 4.394 score on a scale |
| Bupropion | Symptoms of Nicotine Withdrawal Using the Wisconsin Smoking Withdrawal Scale (WSWS) | Sadness | 3.738 score on a scale |
| Bupropion | Symptoms of Nicotine Withdrawal Using the Wisconsin Smoking Withdrawal Scale (WSWS) | Sleep | 8.153 score on a scale |
| Bupropion | Symptoms of Nicotine Withdrawal Using the Wisconsin Smoking Withdrawal Scale (WSWS) | Craving | 6.252 score on a scale |
| Bupropion | Symptoms of Nicotine Withdrawal Using the Wisconsin Smoking Withdrawal Scale (WSWS) | Anxiety | 5.873 score on a scale |
| Bupropion | Symptoms of Nicotine Withdrawal Using the Wisconsin Smoking Withdrawal Scale (WSWS) | Hunger | 10.707 score on a scale |
| Bupropion | Symptoms of Nicotine Withdrawal Using the Wisconsin Smoking Withdrawal Scale (WSWS) | Anger | 4.222 score on a scale |
| Bupropion | Symptoms of Nicotine Withdrawal Using the Wisconsin Smoking Withdrawal Scale (WSWS) | Concentration | 3.407 score on a scale |
| Placebo | Symptoms of Nicotine Withdrawal Using the Wisconsin Smoking Withdrawal Scale (WSWS) | Craving | 6.814 score on a scale |
| Placebo | Symptoms of Nicotine Withdrawal Using the Wisconsin Smoking Withdrawal Scale (WSWS) | Sadness | 4.005 score on a scale |
| Placebo | Symptoms of Nicotine Withdrawal Using the Wisconsin Smoking Withdrawal Scale (WSWS) | Hunger | 9.79 score on a scale |
| Placebo | Symptoms of Nicotine Withdrawal Using the Wisconsin Smoking Withdrawal Scale (WSWS) | Sleep | 9.672 score on a scale |
| Placebo | Symptoms of Nicotine Withdrawal Using the Wisconsin Smoking Withdrawal Scale (WSWS) | Anger | 4.28 score on a scale |
| Placebo | Symptoms of Nicotine Withdrawal Using the Wisconsin Smoking Withdrawal Scale (WSWS) | Anxiety | 6.587 score on a scale |
| Placebo | Symptoms of Nicotine Withdrawal Using the Wisconsin Smoking Withdrawal Scale (WSWS) | Concentration | 4.238 score on a scale |
| Bupropion With DRD2 A1 Allele | Symptoms of Nicotine Withdrawal Using the Wisconsin Smoking Withdrawal Scale (WSWS) | Sadness | 4.338 score on a scale |
| Bupropion With DRD2 A1 Allele | Symptoms of Nicotine Withdrawal Using the Wisconsin Smoking Withdrawal Scale (WSWS) | Concentration | 3.935 score on a scale |
| Bupropion With DRD2 A1 Allele | Symptoms of Nicotine Withdrawal Using the Wisconsin Smoking Withdrawal Scale (WSWS) | Craving | 6.78 score on a scale |
| Bupropion With DRD2 A1 Allele | Symptoms of Nicotine Withdrawal Using the Wisconsin Smoking Withdrawal Scale (WSWS) | Anger | 4.41 score on a scale |
| Bupropion With DRD2 A1 Allele | Symptoms of Nicotine Withdrawal Using the Wisconsin Smoking Withdrawal Scale (WSWS) | Hunger | 11.082 score on a scale |
| Bupropion With DRD2 A1 Allele | Symptoms of Nicotine Withdrawal Using the Wisconsin Smoking Withdrawal Scale (WSWS) | Sleep | 9.528 score on a scale |
| Bupropion With DRD2 A1 Allele | Symptoms of Nicotine Withdrawal Using the Wisconsin Smoking Withdrawal Scale (WSWS) | Anxiety | 6.587 score on a scale |
| Placebo w/o DRD2 A1 Allele | Symptoms of Nicotine Withdrawal Using the Wisconsin Smoking Withdrawal Scale (WSWS) | Sleep | 9.078 score on a scale |
| Placebo w/o DRD2 A1 Allele | Symptoms of Nicotine Withdrawal Using the Wisconsin Smoking Withdrawal Scale (WSWS) | Sadness | 5.293 score on a scale |
| Placebo w/o DRD2 A1 Allele | Symptoms of Nicotine Withdrawal Using the Wisconsin Smoking Withdrawal Scale (WSWS) | Anger | 5.584 score on a scale |
| Placebo w/o DRD2 A1 Allele | Symptoms of Nicotine Withdrawal Using the Wisconsin Smoking Withdrawal Scale (WSWS) | Anxiety | 7.785 score on a scale |
| Placebo w/o DRD2 A1 Allele | Symptoms of Nicotine Withdrawal Using the Wisconsin Smoking Withdrawal Scale (WSWS) | Concentration | 4.764 score on a scale |
| Placebo w/o DRD2 A1 Allele | Symptoms of Nicotine Withdrawal Using the Wisconsin Smoking Withdrawal Scale (WSWS) | Craving | 9.024 score on a scale |
| Placebo w/o DRD2 A1 Allele | Symptoms of Nicotine Withdrawal Using the Wisconsin Smoking Withdrawal Scale (WSWS) | Hunger | 11.207 score on a scale |
| Placebo With DRD2 A1 Allele | Symptoms of Nicotine Withdrawal Using the Wisconsin Smoking Withdrawal Scale (WSWS) | Concentration | 4.951 score on a scale |
| Placebo With DRD2 A1 Allele | Symptoms of Nicotine Withdrawal Using the Wisconsin Smoking Withdrawal Scale (WSWS) | Anger | 5.752 score on a scale |
| Placebo With DRD2 A1 Allele | Symptoms of Nicotine Withdrawal Using the Wisconsin Smoking Withdrawal Scale (WSWS) | Hunger | 11.044 score on a scale |
| Placebo With DRD2 A1 Allele | Symptoms of Nicotine Withdrawal Using the Wisconsin Smoking Withdrawal Scale (WSWS) | Anxiety | 7.915 score on a scale |
| Placebo With DRD2 A1 Allele | Symptoms of Nicotine Withdrawal Using the Wisconsin Smoking Withdrawal Scale (WSWS) | Sadness | 5.865 score on a scale |
| Placebo With DRD2 A1 Allele | Symptoms of Nicotine Withdrawal Using the Wisconsin Smoking Withdrawal Scale (WSWS) | Sleep | 8.629 score on a scale |
| Placebo With DRD2 A1 Allele | Symptoms of Nicotine Withdrawal Using the Wisconsin Smoking Withdrawal Scale (WSWS) | Craving | 8.696 score on a scale |