Smoking Cessation
Conditions
Keywords
Smoking Cessation, Nicotine Withdrawal, Smoking Reduction, Varenicline, Chantix, Bupropion, Zyban
Brief summary
The goal of this clinical research study is learn if the combination of Chantix (varenicline) and Zyban (bupropion) is more effective at helping people to quit smoking than varenicline when given alone. Researchers also want to learn if this drug combination can reduce cravings and other negative symptoms of nicotine withdrawal better than varenicline does alone. The safety of this drug combination will also be tested.
Detailed description
The Study Drugs: Bupropion and varenicline are designed to imitate the effects that nicotine has on the body. This may reduce cigarette cravings and help patients quit smoking. Study Groups: If you are found to be eligible to take part in this study, you will be randomly assigned (as in the roll of a dice) to 1 of 3 treatment groups. * If you are in Group 1, you will receive varenicline and bupropion. * If you are in Group 2, you will receive varenicline and a placebo. A placebo is a substance that looks like the study drug (in this case, bupropion) but that has no active ingredients. * If you are in Group 3, you will receive a placebo that looks like varenicline and a placebo that looks like bupropion. You will have a higher chance (5 out of 6) of receiving study drug than receiving just placebo. Equal numbers of patients will be in Groups 1 and 2. Neither you nor the study doctor will know to which group you are assigned. However, if needed for your safety, the study staff will be able to find out which study drug you are receiving. Study Drug Administration: You will begin taking the study drugs/placebo 1 to 10 days after the first study visit. A dose of the study drug/placebo combination will be made up of 1 tablet of varenicline or placebo and 1 tablet of bupropion or placebo. You should take each dose of study drugs/placebo with a cup (8 oz.) of water after eating a full meal. On Days 1-3, you will take 1 dose of the study drug/placebo combination in the morning. Beginning on Day 4, and then every day after that, you will take 1 dose in the morning and 1 dose in the evening (for a total of 2 doses of the study drug/placebo combination each day). You must return any study drug bottles as well as any unused study drug to a study staff member at each study visit. You will be given a smoking diary to record how many cigarettes you smoke (if any) each day while you are on study. You must turn in this diary at each study visit. Study Visits: About 1 time each week while you are taking the study drugs/placebo, the following tests and procedures will be performed: * Your weight and blood pressure will be measured. * Your CO level will be measured. * You will be asked about any other drugs you may be taking and about any side effects you may be having. * You will answer 8 questionnaires about several topics, including depression, suicide, your smoking behavior, any effects from the study drugs, and any symptoms of attention-deficit hyperactivity disorder (ADHD). These should take about 30-45 minutes total to complete. * You will do tasks that will measure your logic and attention. These will take about 15 -20 minutes to complete. * You will receive counseling about quitting smoking in which you discuss possible triggers for smoking and strategies for dealing with quitting smoking. These sessions will take about 15 minutes each time. During counseling at the first study visit, you will set a quit date for stopping smoking for about 1 week after you start taking the study drug. You should not quit smoking before the quit date. You should stay smoke-free after the quit date. Additionally, you will be given a medication instruction sheet, a card with emergency contact information, and a participant manual to help you follow along with the topics discussed during counseling. At Week 2, saliva will be collected to check your cotinine level. At Week 4, blood (about 2 teaspoons) will be drawn to assess liver and kidney function. Lab Sessions: You may be asked to take part in lab sessions during Visits 1, 2, and 6 to test your brain activity and attention span. You will be asked to watch slides and listen to a series of tones. The slides will include pictures of people, nature, and artwork. Slides showing nude people, medical procedures, and victims of car crashes 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 brain electrical activity (EEG) will be monitored. To do this, small sensors will be placed on your scalp and face. You should not drink more than 2 cups of coffee or other caffeinated drinks for at least 2.5 hours before each session. At the first lab session, you may be asked to smoke a cigarette if the doctor thinks it is needed for you to exhibit your normal smoking behavior. Length of Study: You will receive the study drug for up to 12 weeks. However, the entire length of the study is about 13 months (55 weeks), which includes 3, 6, and 12-month post-quit follow up visits. You will be taken off study if the doctor thinks it is in your best interest. End-of-Study Visit: After you have finished taking the study drugs/placebo, the following tests and procedures will be performed: * Your weight and blood pressure will be measured. * Your CO level will be measured. * You will be asked about any side effects you may be having and about any other drugs you may be taking. * Blood (about 2 teaspoons) will be drawn to assess liver and kidney function. * You will answer the same questionnaires you completed at the regular study visits. These should take about 30-45 minutes total to complete. * Saliva will be collected to measure your cotinine level. Follow-Up Visits: About 3, 6, and 12 months after you have stopped smoking, the following tests and procedures will be performed: * Your weight, heart rate, and blood pressure will be measured. * Your CO level will be measured. * You will be asked about any side effects you may be having and about any other drugs you may be taking. * You will answer the same questionnaires you completed at the regular study visits. These should take about 30-45 minutes total to complete. * Saliva will be collected to measure your cotinine level. You will be called by the study staff 1 day before your quit date, 3 days after your quit date, and at Weeks 14, 20, 34, 42, and 48 weeks after your quit date to check on your progress in quitting smoking. Each call should take about 10-15 minutes. This is an investigational study. Varenicline and bupropion are both FDA approved and commercially available to help people stop smoking. The use of the drugs in combination is investigational. Up to 385 participants will take part in this study. All will be enrolled at MD Anderson.
Interventions
DRUGVarenicline
On Days 1-3, .5mg tablet by mouth in the morning. Beginning on Day 4, and then every day after that, .5mg tablet by mouth in the morning and .5mg tablet by mouth in the evening (for a total of 2 doses).
DRUGBupropion
On Days 1-3, 150 mg tablet by mouth in the morning. Beginning on Day 4, and then every day after that, 150 mg tablet by mouth in the morning and 150 mg tablet by mouth in the evening (for a total of 2 doses).
OTHERPlacebo
On Days 1-3, 1 tablet by mouth of placebo that looks like the study drug in the morning. Beginning on Day 4, and then every day after that, 1 tablet by mouth in the morning and 1 tablet by mouth in the evening for a total of 2 doses of the placebo each day.
BEHAVIORALCounseling/Phone Calls
Brief-behavioral counseling sessions (10-15 minutes) provided to all participants once per week for 12 weeks. One support phone call conducted 3 days after the target quit date.
Sponsors
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Pfizer
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
25 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age: 25-70 years old 2. Smoking 5 or more cigarettes per day, on average, within the 2 months preceding the screening visit and expired CO of greater than or equal to 6ppm. 3. Able to follow verbal and written instructions in English and complete all aspects of the study 4. Provide informed consent and agree to all assessments and study procedures 5. Have an address and home telephone number where they may be reached 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 products other than cigarettes on 3 or more days within a week if the individual refuses to refrain from such tobacco use during the course of the 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. Treatment on a continuous basis within 2 weeks before the screening visit: any contraindicated medication for Varenicline or Bupropion. Classes of contraindicated medications include, but are not limited to, antiasthmatics, antipsychotics, some antidepressants, antihypertensives, antiarrhythmics, antineoplastics, some antiseizures, and MAO inhibitors (See Appendix U for specific list of excluded and precautionary medications). 5. Uncontrolled hypertension (average reading of systolic blood pressure greater than 150 or diastolic blood pressure greater than 95) or other major contraindications for Bupropion or Varenicline (See section on Screening). 6. Severe renal impairment (Creatinine Clearance less than 30 ml/min/1.73 m2). 7. Laboratory evaluations outside normal limits and of potential clinical significance in the opinion of the investigator. 8. Meet current criteria for psychiatric disorders or substance abuse as assessed by the MINI plus (major depressive episode) and the MINI for items B, D, I, J (Alcohol Addendum-past 6 months only), K, L, M and N including a past manic or hypomanic episode as well as a lifetime psychotic disorder. 9. Individuals rated as moderate (6 - 9) to high (10 or greater) on suicidality as assessed by Module C of the MINI. 10. Psychiatric hospitalization within 1 year of screening date. 11. A positive urine pregnancy test during the screening period. Women who are two years post menopausal, or who have had a tubal ligation or a partial or full hysterectomy will not be subject to a urine pregnancy test. 12. Pregnant, breast-feeding or of childbearing potential and is not protected by a medically acceptable, effective method of birth control while enrolled in the study. Medically acceptable contraceptives include: (1) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (2) barrier methods (such as a condom or diaphragm) used with a spermicide, or (3) an intrauterine device (IUD). Contraceptive measures sold for emergency use after unprotected sex, are not acceptable methods for routine use. 13. Use of Varenicline or Bupropion within two weeks before the screening visit. 14. History of hypersensitivity or allergic reaction to Varenicline, tricyclic antidepressant, Bupropion (Wellbutrin, Zyban) or similar chemical classes or any component of these formulations. 15. Current or previous history of a seizure disorder. 16. Current or previous history of anorexia. 17. 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 |
|---|---|---|
| Smoking Abstinence at 12 Months | From quit date to 12 months. | Prolonged Abstinence is defined as no smoking from the quit date to 12 Months post quit date. |
Countries
United States
Participant flow
Recruitment details
Paid and unpaid media advertising from May 2010 to July 2013 recruited volunteer smokers from the Houston, Texas metropolitan area. Inclusion criteria included: 25- 65 years of age; smoke five or more cigarettes per day (CPD); baseline expired carbon monoxide (CO) level greater than 6 parts per million (p.m.); fluent in English; stable residency.
Pre-assignment details
641 patients were consented to this study; 250 patients were screen failures.
Participants by arm
| Arm | Count |
|---|---|
| Varenicline + Bupropion Smokers in varenicline + bupropion took 0.5 mg varenicline once per day for the first three days and 0.5 mg bid (am and pm) for the next 4 days. They also took 150 mg bupropion (SR once per day for the first 3 days followed by 150mg bid for the next 4 days. From week 2-12 smokers in the VB group will take 1mg of varenicline and one active 150 mg bupropion tablet twice per day. | 163 |
| Varenicline Smokers in varenicline group took took 0.5 mg varenicline once per day for the first three days and 0.5 mg bid (am and pm) for the next 4 days. They also took a matching bupropion placebo on the same schedule as those in the varenicline + bupropion group. From week 2-12, smokers in the varenicline group took 1mg of varenicline and one bupropion matching placebo twice per day. | 166 |
| Placebo Smokers in the placebo group took a matching varenicline and bupropion placebos on the same schedule as the varenicline group took varenicline and the bupropion group took bupropion, respectively. | 56 |
| Total | 385 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Discontinued Medication | 17 | 29 | 11 |
| Overall Study | Lost to Follow-up | 38 | 48 | 20 |
Baseline characteristics
| Characteristic | Total | Varenicline + Bupropion | Varenicline | Placebo |
|---|---|---|---|---|
| Age, Continuous | 48.97 years STANDARD_DEVIATION 10.17 | 49.36 years STANDARD_DEVIATION 9.38 | 48.75 years STANDARD_DEVIATION 10.89 | 48.48 years STANDARD_DEVIATION 10.33 |
| Age started smoking | 18.02 years STANDARD_DEVIATION 5.44 | 18.41 years STANDARD_DEVIATION 5.15 | 18.16 years STANDARD_DEVIATION 60.16 | 16.48 years STANDARD_DEVIATION 3.43 |
| Center for Epidemiologic Studies Depression Scale (CESD) | 6.73 score on a scale STANDARD_DEVIATION 6.27 | 5.82 score on a scale STANDARD_DEVIATION 5.37 | 7.76 score on a scale STANDARD_DEVIATION 7.07 | 6.59 score on a scale STANDARD_DEVIATION 6.17 |
| Current Smoking Rate | 19.66 cigs per day STANDARD_DEVIATION 9.45 | 19.64 cigs per day STANDARD_DEVIATION 9.49 | 19.02 cigs per day STANDARD_DEVIATION 9.49 | 19.71 cigs per day STANDARD_DEVIATION 11.2 |
| Depression History Negative | 362 Participants | 154 Participants | 156 Participants | 52 Participants |
| Depression History Positive | 23 Participants | 9 Participants | 10 Participants | 4 Participants |
| Employment Status Employed/Student | 81.25 percentage of participants | 82.72 percentage of participants | 80.72 percentage of participants | 78.57 percentage of participants |
| Employment Status Unemployed | 18.75 percentage of participants | 17.28 percentage of participants | 19.28 percentage of participants | 21.43 percentage of participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 30 Participants | 10 Participants | 14 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 340 Participants | 146 Participants | 146 Participants | 48 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 15 Participants | 7 Participants | 6 Participants | 2 Participants |
| Fagerström Test for Nicotine Dependence (FTND) Total Score | 4.79 score on a scale STANDARD_DEVIATION 2.07 | 4.74 score on a scale STANDARD_DEVIATION 2.01 | 4.65 score on a scale STANDARD_DEVIATION 2.04 | 5.34 score on a scale STANDARD_DEVIATION 2.24 |
| Marital Status Married or Living with partner | 50.13 percentage of participants | 42.94 percentage of participants | 53.01 percentage of participants | 62.50 percentage of participants |
| Marital Status Other | 49.87 percentage of participants | 57.06 percentage of participants | 46.99 percentage of participants | 37.50 percentage of participants |
| Number of Previous Quit Attempts | 6.62 Number of quit attempts STANDARD_DEVIATION 11.94 | 7.58 Number of quit attempts STANDARD_DEVIATION 13.51 | 5.83 Number of quit attempts STANDARD_DEVIATION 9.22 | 6.12 Number of quit attempts STANDARD_DEVIATION 13.9 |
| Positive and Negative Affect Schedule (PANAS) PANAS Negative | 14.70 units on a scale STANDARD_DEVIATION 5.02 | 14.56 units on a scale STANDARD_DEVIATION 4.93 | 14.93 units on a scale STANDARD_DEVIATION 5.31 | 14.44 units on a scale STANDARD_DEVIATION 4.39 |
| Positive and Negative Affect Schedule (PANAS) PANAS Positive | 33.69 units on a scale STANDARD_DEVIATION 7.72 | 34.08 units on a scale STANDARD_DEVIATION 7.64 | 33.26 units on a scale STANDARD_DEVIATION 7.43 | 33.84 units on a scale STANDARD_DEVIATION 8.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 1 Participants | 5 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 103 Participants | 44 Participants | 43 Participants | 16 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 3 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 14 Participants | 8 Participants | 5 Participants | 1 Participants |
| Race (NIH/OMB) White | 252 Participants | 106 Participants | 110 Participants | 36 Participants |
| Region of Enrollment United States | 385 participants | 163 participants | 166 participants | 56 participants |
| Sex: Female, Male Female | 160 Participants | 68 Participants | 68 Participants | 24 Participants |
| Sex: Female, Male Male | 225 Participants | 95 Participants | 98 Participants | 32 Participants |
| Wisconsin Index of Smoking Dependence Motives (WISDM) WISDM-Affect | 4.85 units on a scale STANDARD_DEVIATION 2 | 4.83 units on a scale STANDARD_DEVIATION 2 | 4.75 units on a scale STANDARD_DEVIATION 2.01 | 5.22 units on a scale STANDARD_DEVIATION 1.97 |
| Wisconsin Index of Smoking Dependence Motives (WISDM) WISDM-Affiliation | 4.09 units on a scale STANDARD_DEVIATION 2.22 | 4.20 units on a scale STANDARD_DEVIATION 2.13 | 3.87 units on a scale STANDARD_DEVIATION 2.22 | 4.41 units on a scale STANDARD_DEVIATION 2.42 |
| Wisconsin Index of Smoking Dependence Motives (WISDM) WISDM-Automaticity | 5.90 units on a scale STANDARD_DEVIATION 2.11 | 6.05 units on a scale STANDARD_DEVIATION 2.02 | 5.57 units on a scale STANDARD_DEVIATION 2.17 | 6.42 units on a scale STANDARD_DEVIATION 2.11 |
| Wisconsin Index of Smoking Dependence Motives (WISDM) WISDM-Cognitive | 4.56 units on a scale STANDARD_DEVIATION 2.12 | 4.66 units on a scale STANDARD_DEVIATION 2.09 | 4.37 units on a scale STANDARD_DEVIATION 2.17 | 4.82 units on a scale STANDARD_DEVIATION 2.05 |
| Wisconsin Index of Smoking Dependence Motives (WISDM) WISDM-Control | 6.28 units on a scale STANDARD_DEVIATION 1.85 | 6.17 units on a scale STANDARD_DEVIATION 1.73 | 6.32 units on a scale STANDARD_DEVIATION 1.87 | 6.51 units on a scale STANDARD_DEVIATION 2.09 |
| Wisconsin Index of Smoking Dependence Motives (WISDM) WISDM-Craving | 6.11 units on a scale STANDARD_DEVIATION 1.73 | 6.11 units on a scale STANDARD_DEVIATION 1.62 | 5.95 units on a scale STANDARD_DEVIATION 1.78 | 6.53 units on a scale STANDARD_DEVIATION 1.83 |
| Wisconsin Index of Smoking Dependence Motives (WISDM) WISDM-Cue Exposure-Associative Processes | 5.38 units on a scale STANDARD_DEVIATION 1.9 | 5.36 units on a scale STANDARD_DEVIATION 1.82 | 5.34 units on a scale STANDARD_DEVIATION 2.02 | 5.56 units on a scale STANDARD_DEVIATION 1.74 |
| Wisconsin Index of Smoking Dependence Motives (WISDM) WISDM-Primary Dependence Motives | 6.08 units on a scale STANDARD_DEVIATION 1.61 | 6.08 units on a scale STANDARD_DEVIATION 1.53 | 5.96 units on a scale STANDARD_DEVIATION 1.64 | 6.43 units on a scale STANDARD_DEVIATION 1.75 |
| Wisconsin Index of Smoking Dependence Motives (WISDM) WISDM-Secondary Dependence Motives | 4.51 units on a scale STANDARD_DEVIATION 1.43 | 4.57 units on a scale STANDARD_DEVIATION 1.36 | 4.38 units on a scale STANDARD_DEVIATION 1.48 | 4.71 units on a scale STANDARD_DEVIATION 1.46 |
| Wisconsin Index of Smoking Dependence Motives (WISDM) WISDM-Social-Environmental Goads | 3.94 units on a scale STANDARD_DEVIATION 2.42 | 4.00 units on a scale STANDARD_DEVIATION 2.22 | 3.77 units on a scale STANDARD_DEVIATION 2.54 | 4.25 units on a scale STANDARD_DEVIATION 2.59 |
| Wisconsin Index of Smoking Dependence Motives (WISDM) WISDM-Taste and Sensory Processes | 5.41 units on a scale STANDARD_DEVIATION 2.16 | 5.52 units on a scale STANDARD_DEVIATION 2.06 | 5.29 units on a scale STANDARD_DEVIATION 2.27 | 5.50 units on a scale STANDARD_DEVIATION 2.11 |
| Wisconsin Index of Smoking Dependence Motives (WISDM) WISDM-Tolerance | 6.04 units on a scale STANDARD_DEVIATION 2.07 | 6.01 units on a scale STANDARD_DEVIATION 2.04 | 6.01 units on a scale STANDARD_DEVIATION 2.11 | 6.26 units on a scale STANDARD_DEVIATION 2.04 |
| Wisconsin Index of Smoking Dependence Motives (WISDM) WISDM-Total | 55.89 units on a scale STANDARD_DEVIATION 15.03 | 56.32 units on a scale STANDARD_DEVIATION 14.11 | 54.54 units on a scale STANDARD_DEVIATION 15.66 | 58.65 units on a scale STANDARD_DEVIATION 15.53 |
| Wisconsin Index of Smoking Dependence Motives (WISDM) WISDM-Weight Control | 3.32 units on a scale STANDARD_DEVIATION 2.03 | 3.40 units on a scale STANDARD_DEVIATION 1.93 | 3.29 units on a scale STANDARD_DEVIATION 2.1 | 3.18 units on a scale STANDARD_DEVIATION 2.12 |
| Wisconsin Smoking Withdrawal Scale (WSWS) Anger | 3.77 score on a scale STANDARD_DEVIATION 2.37 | 3.57 score on a scale STANDARD_DEVIATION 2.25 | 4.01 score on a scale STANDARD_DEVIATION 2.48 | 3.67 score on a scale STANDARD_DEVIATION 23.8 |
| Wisconsin Smoking Withdrawal Scale (WSWS) Anxiety | 6.92 score on a scale STANDARD_DEVIATION 2.84 | 6.80 score on a scale STANDARD_DEVIATION 2.74 | 6.96 score on a scale STANDARD_DEVIATION 2.99 | 7.15 score on a scale STANDARD_DEVIATION 2.76 |
| Wisconsin Smoking Withdrawal Scale (WSWS) Concentration | 3.80 score on a scale STANDARD_DEVIATION 2.02 | 3.80 score on a scale STANDARD_DEVIATION 2.05 | 3.84 score on a scale STANDARD_DEVIATION 2.02 | 3.69 score on a scale STANDARD_DEVIATION 1.99 |
| Wisconsin Smoking Withdrawal Scale (WSWS) Craving | 9.67 score on a scale STANDARD_DEVIATION 2.8 | 9.40 score on a scale STANDARD_DEVIATION 2.63 | 9.86 score on a scale STANDARD_DEVIATION 2.94 | 9.87 score on a scale STANDARD_DEVIATION 2.85 |
| Wisconsin Smoking Withdrawal Scale (WSWS) Hunger | 10.10 score on a scale STANDARD_DEVIATION 3.46 | 9.67 score on a scale STANDARD_DEVIATION 3.39 | 10.46 score on a scale STANDARD_DEVIATION 3.5 | 10.31 score on a scale STANDARD_DEVIATION 3.44 |
| Wisconsin Smoking Withdrawal Scale (WSWS) Sadness | 4.57 score on a scale STANDARD_DEVIATION 2.31 | 4.38 score on a scale STANDARD_DEVIATION 2.21 | 4.76 score on a scale STANDARD_DEVIATION 2.48 | 4.55 score on a scale STANDARD_DEVIATION 2.04 |
| Wisconsin Smoking Withdrawal Scale (WSWS) Sleep | 8.21 score on a scale STANDARD_DEVIATION 4.29 | 7.91 score on a scale STANDARD_DEVIATION 4.04 | 8.52 score on a scale STANDARD_DEVIATION 4.48 | 8.16 score on a scale STANDARD_DEVIATION 4.47 |
| Years of education | 13.75 years STANDARD_DEVIATION 2 | 13.89 years STANDARD_DEVIATION 2.11 | 13.60 years STANDARD_DEVIATION 1.92 | 13.80 years STANDARD_DEVIATION 1.89 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 163 | 0 / 166 | 0 / 56 |
| other Total, other adverse events | 160 / 163 | 156 / 166 | 50 / 56 |
| serious Total, serious adverse events | 8 / 163 | 4 / 166 | 1 / 56 |
Outcome results
Primary
Smoking Abstinence at 12 Months
Prolonged Abstinence is defined as no smoking from the quit date to 12 Months post quit date.
Time frame: From quit date to 12 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Varenicline + Bupropion | Smoking Abstinence at 12 Months | 30 Participants |
| Varenicline | Smoking Abstinence at 12 Months | 33 Participants |
| Placebo | Smoking Abstinence at 12 Months | 2 Participants |