Nicotine Dependence
Conditions
Keywords
Nicotine addiction, Cigarette smoking, Smoking cessation, Zyban, Chantix, Nicotine patches, varenicline, bupropion
Brief summary
Previous results from the investigators' Center have shown that combination treatment with Chantix and Zyban is more successful in helping men quit smoking. The investigators hope to replicate these findings with this study.
Interventions
DRUGChantix
DRUGZyban
DRUGNicotine patches
All participants will receive 21 mg/24 h dose nicotine (nic.) patches for 1 week.
Sponsors
National Institute on Drug Abuse (NIDA)
Philip Morris USA, Inc.
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Have no known serious medical conditions; * Male; * Are 18-65 years old; * Smoke an average of at least 10 cigarettes per day; * Have smoked at least one cumulative year; * Have an expired air carbon monoxide (CO) reading of at least 10ppm; * Able to read and understand English; * Express a desire to quit smoking in the next thirty days. Potential subjects must agree to use acceptable contraception. Potential subjects must agree to avoid the following: * participation in any other nicotine-related modification strategy outside of this protocol; * use of tobacco products other than cigarettes, including pipe tobacco, cigars, e-cigarettes, snuff, and chewing tobacco; * use of experimental (investigational) drugs or devices; * use of illegal drugs; * use of opiate medications.
Exclusion criteria
* Hypertension; * Hypotension with symptoms; * Coronary heart disease; * Lifetime history of heart attack; * Cardiac rhythm disorder (irregular heart rhythm); * Chest pains (unless history, exam, and electrocardiogram (ECG) clearly indicate a non-cardiac source); * Cardiac (heart) disorder (including but not limited to valvular heart disease, heart murmur, heart failure); * History of skin allergy; * Active skin disorder (e.g., psoriasis) within the last five years; * Liver or kidney disorder (except kidney stones, gallstones); * Gastrointestinal problems or disease other than gastroesophageal reflux or heartburn; * Active ulcers in the past 30 days; * Currently symptomatic lung disorder/disease (including but not limited to Chronic obstructive pulmonary disease (COPD), emphysema, and asthma); * Brain abnormality (including but not limited to stroke, brain tumor, and seizure disorder); * Migraine headaches that occur more frequently than once per week; * Recent, unexplained fainting spells; * Problems giving blood samples; * Diabetes treated with insulin; non-insulin treated diabetes (unless glucose is less than 180mg/dcl and HbA1c is less than 7%); * Current cancer or treatment for cancer in the past six months (except basal or squamous cell skin cancer); * Other major medical condition; * Current psychiatric disease (with the exception of anxiety disorders, Obsessive Compulsive Disorder (OCD) and ADHD); * Suicidal ideation (within the past 10 years) or lifetime occurrence of attempted suicide; * Current depression; * Bulimia or anorexia; * Use of opiate medications for pain or sleep (non-opiate medication for pain or sleep will be allowed) within the past 14 days; * Smoking more than one cigar a month. * Alcohol abuse; * Significant adverse reaction to nicotine patches, bupropion / Wellbutrin / Zyban or Chantix / varenicline in the past. * Current participation or recent participation (in the past 30 days) in another smoking study at our Center or another research facility. * Current participation in another research study. Use (within the past 30 days) of: * Illegal drugs (or if the urine drug screen is positive for tetrahydrocannabinol (THC), Cocaine, Amphetamine, Opiates, Methamphetamines, phencyclidine (PCP), Benzodiazepines, or Barbiturates), * Experimental (investigational) drugs; * Psychiatric medications including antidepressants, anti-psychotics or any other medications that are known to affect smoking cessation (e.g. clonidine); * Smokeless tobacco (chewing tobacco, snuff), pipes or e-cigarettes; * Wellbutrin, bupropion, Zyban, Chantix, varenicline, nicotine replacement therapy or any other smoking cessation aid.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Completing Continuous Four-week Abstinence From Smoking Between the 8-week and 11-week Post Quit Day Visits | Period between 8-week and 11-week visits post target Quit Day | This will be determined by a composite of self-report at the 11-week study visit of no smoking between the 8-week and 11-week visits and expired air carbon monoxide (CO) \<10 ppm (measured at the 11-week study visit). An intent-to-treat criterion will be used, whereby drop-outs are considered to be non-abstinent. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Completing Seven-day Point Abstinence From Smoking at 6 Months Post Quit Day | 6 months post Quit Day | This will be determined by a self-report of no smoking for the previous seven days when called for 6-month follow-up confirmed by expired air CO. |
| Number of Participants Completing Continuous Abstinence From Smoking Between Quit Day and 11-week Post Quit Day Visit | Quit Day to 11-week post Quit Day study visit | This will be determined by a composite of self-report of no smoking between study visits at the 1-week, 3-week, 7-week and 11-week post Quit Day study visits and expired air carbon monoxide (CO) \<10 ppm (measured at those study visits). An intent-to-treat criterion will be used, whereby drop-outs are considered to be non-abstinent. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Smoking Withdrawal Symptoms | Quit Day and 1 week, 3 weeks, 7 Weeks, 11 Weeks and 6 months post Quit Day | Withdrawal symptoms will be assessed by questionnaire on Quit Day, Week 1, Week 3, Week 7 and Week 11 post target quit date and 6 months post quit Follow-Up (if applicable) using the Shiffman-Jarvik questionnaire, which consists of 33-items rated from 1 to 7, where 1= not at all, 2= very little, 3= a little, 4= moderately, 5= a lot, 6= quite a lot, and 7= extremely. The 33 items are grouped into 8 subscales: Craving, Negative Affect, Appetite, Arousal, Somatic - Anxiety, Somatic - G.I., Somatic - Respiratory Tract, and Habit Withdrawal. The range of scores for each subscale will be 1-7, with higher scores indicating more of the withdrawal symptom having been experienced. |
Countries
United States
Participant flow
Recruitment details
Recruitment began on 3/4/2013 and ended on 9/7/2014. Of the 376 subjects (subjs.) consented during this period, 197 subjects met all study criteria.
Pre-assignment details
Of the 376 subjs. enrolled, 179 were withdrawn by study staff or withdrew voluntarily from further participation prior to the 1st study visit (V1). 197 subjs. met all study criteria, attended V1 & given NRT for 1 week; 176 subjs. attended V2 & completed SE quest.; 2 subjs. dropped out during this visit before randomization; 174 subjs. randomized.
Participants by arm
| Arm | Count |
|---|---|
| Chantix For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.
Chantix
Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week. | 90 |
| Chantix + Zyban For the first 3 days after being switched from NRT (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.
Chantix
Zyban
Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week. | 84 |
| Total | 174 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lack of Efficacy | 1 | 1 | 0 |
| Overall Study | Lost to Follow-up | 19 | 20 | 0 |
| Overall Study | Physician Decision | 2 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 20 | 23 | 22 |
Baseline characteristics
| Characteristic | Chantix | Chantix + Zyban | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 90 Participants | 84 Participants | 174 Participants |
| Age, Continuous | 44.75 years STANDARD_DEVIATION 11.381 | 43.12 years STANDARD_DEVIATION 10.562 | 43.96 years STANDARD_DEVIATION 10.992 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 88 Participants | 83 Participants | 171 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 20 Participants | 26 Participants | 46 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) White | 66 Participants | 57 Participants | 123 Participants |
| Region of Enrollment United States | 90 participants | 84 participants | 174 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 90 Participants | 84 Participants | 174 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 39 / 87 | 53 / 83 | 57 / 176 |
| serious Total, serious adverse events | 3 / 90 | 2 / 84 | 0 / 197 |
Outcome results
Primary
Number of Participants Completing Continuous Four-week Abstinence From Smoking Between the 8-week and 11-week Post Quit Day Visits
This will be determined by a composite of self-report at the 11-week study visit of no smoking between the 8-week and 11-week visits and expired air carbon monoxide (CO) \<10 ppm (measured at the 11-week study visit). An intent-to-treat criterion will be used, whereby drop-outs are considered to be non-abstinent.
Time frame: Period between 8-week and 11-week visits post target Quit Day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Chantix | Number of Participants Completing Continuous Four-week Abstinence From Smoking Between the 8-week and 11-week Post Quit Day Visits | 41 participants |
| Chantix + Zyban | Number of Participants Completing Continuous Four-week Abstinence From Smoking Between the 8-week and 11-week Post Quit Day Visits | 38 participants |
Secondary
Number of Participants Completing Continuous Abstinence From Smoking Between Quit Day and 11-week Post Quit Day Visit
This will be determined by a composite of self-report of no smoking between study visits at the 1-week, 3-week, 7-week and 11-week post Quit Day study visits and expired air carbon monoxide (CO) \<10 ppm (measured at those study visits). An intent-to-treat criterion will be used, whereby drop-outs are considered to be non-abstinent.
Time frame: Quit Day to 11-week post Quit Day study visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Chantix | Number of Participants Completing Continuous Abstinence From Smoking Between Quit Day and 11-week Post Quit Day Visit | 21 participants |
| Chantix + Zyban | Number of Participants Completing Continuous Abstinence From Smoking Between Quit Day and 11-week Post Quit Day Visit | 15 participants |
Secondary
Number of Participants Completing Seven-day Point Abstinence From Smoking at 6 Months Post Quit Day
This will be determined by a self-report of no smoking for the previous seven days when called for 6-month follow-up confirmed by expired air CO.
Time frame: 6 months post Quit Day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Chantix | Number of Participants Completing Seven-day Point Abstinence From Smoking at 6 Months Post Quit Day | 21 participants |
| Chantix + Zyban | Number of Participants Completing Seven-day Point Abstinence From Smoking at 6 Months Post Quit Day | 19 participants |
Other Pre-specified
Change in Smoking Withdrawal Symptoms
Withdrawal symptoms will be assessed by questionnaire on Quit Day, Week 1, Week 3, Week 7 and Week 11 post target quit date and 6 months post quit Follow-Up (if applicable) using the Shiffman-Jarvik questionnaire, which consists of 33-items rated from 1 to 7, where 1= not at all, 2= very little, 3= a little, 4= moderately, 5= a lot, 6= quite a lot, and 7= extremely. The 33 items are grouped into 8 subscales: Craving, Negative Affect, Appetite, Arousal, Somatic - Anxiety, Somatic - G.I., Somatic - Respiratory Tract, and Habit Withdrawal. The range of scores for each subscale will be 1-7, with higher scores indicating more of the withdrawal symptom having been experienced.
Time frame: Quit Day and 1 week, 3 weeks, 7 Weeks, 11 Weeks and 6 months post Quit Day
Population: A total of 163 subjects (Chantix n=82, Chantix+Zyban n=81) attended the first post-quit visit. However, ten subjects (5 in each condition) failed to complete or return their Quit Day withdrawal questionnaires; therefore change scores could only be calculated for 153 subjects (Chantix n=77, Chantix+Zyban n=76).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chantix | Change in Smoking Withdrawal Symptoms | Anxiety -- % change 7 weeks from Quit Day | -11.82 percentage of change | Standard Error 3.25 |
| Chantix | Change in Smoking Withdrawal Symptoms | Appetite -- % change 7 weeks from Quit Day | -9.30 percentage of change | Standard Error 5.981 |
| Chantix | Change in Smoking Withdrawal Symptoms | Anxiety -- % change 11 weeks from Quit Day | -9.34 percentage of change | Standard Error 3.526 |
| Chantix | Change in Smoking Withdrawal Symptoms | Negative Affect -- % change 1 week from Quit Day | -11.45 percentage of change | Standard Error 2.551 |
| Chantix | Change in Smoking Withdrawal Symptoms | Anxiety -- % change 6 months from Quit Day | -66.77 percentage of change | Standard Error 3.269 |
| Chantix | Change in Smoking Withdrawal Symptoms | Appetite -- % change 11 weeks from Quit Day | -16.20 percentage of change | Standard Error 7.153 |
| Chantix | Change in Smoking Withdrawal Symptoms | Gastrointestinal -- % change 1 week from Quit Day | -0.69 percentage of change | Standard Error 3.72 |
| Chantix | Change in Smoking Withdrawal Symptoms | Negative Affect -- % change 11 weeks from Quit Day | -15.06 percentage of change | Standard Error 3.396 |
| Chantix | Change in Smoking Withdrawal Symptoms | Gastrointestinal -- % change 3 weeks from Quit Day | -5.14 percentage of change | Standard Error 2.994 |
| Chantix | Change in Smoking Withdrawal Symptoms | Appetite -- % change 6 months from Quit Day | -33.88 percentage of change | Standard Error 10.872 |
| Chantix | Change in Smoking Withdrawal Symptoms | Gastrointestinal -- % change 7 weeks from Quit Day | -7.67 percentage of change | Standard Error 3.231 |
| Chantix | Change in Smoking Withdrawal Symptoms | Craving -- % change 6 months from Quit Day | -42.96 percentage of change | Standard Error 6.563 |
| Chantix | Change in Smoking Withdrawal Symptoms | Gastrointestinal - % change 11 weeks from Quit Day | -8.05 percentage of change | Standard Error 3.357 |
| Chantix | Change in Smoking Withdrawal Symptoms | Arousal -- % change 1 week from Quit Day | 8.03 percentage of change | Standard Error 5.62 |
| Chantix | Change in Smoking Withdrawal Symptoms | Gastrointestinal - % change 6 months from Quit Day | -67.72 percentage of change | Standard Error 3.245 |
| Chantix | Change in Smoking Withdrawal Symptoms | Negative Affect -- % change 6 months from Quit Day | -8.55 percentage of change | Standard Error 10.707 |
| Chantix | Change in Smoking Withdrawal Symptoms | Respiratory -- % change 1 week from Quit Day | 1.41 percentage of change | Standard Error 3.113 |
| Chantix | Change in Smoking Withdrawal Symptoms | Arousal -- % change 3 weeks from Quit Day | 5.87 percentage of change | Standard Error 5.675 |
| Chantix | Change in Smoking Withdrawal Symptoms | Respiratory -- % change 3 weeks from Quit Day | -1.12 percentage of change | Standard Error 4.694 |
| Chantix | Change in Smoking Withdrawal Symptoms | Negative Affect -- % change 3 weeks from Quit Day | -9.74 percentage of change | Standard Error 2.494 |
| Chantix | Change in Smoking Withdrawal Symptoms | Respiratory -- % change 7 weeks from Quit Day | 0.92 percentage of change | Standard Error 6.534 |
| Chantix | Change in Smoking Withdrawal Symptoms | Arousal -- % change 7 weeks from Quit Day | 6.94 percentage of change | Standard Error 6.763 |
| Chantix | Change in Smoking Withdrawal Symptoms | Respiratory -- % change 11 weeks from Quit Day | -4.36 percentage of change | Standard Error 6.014 |
| Chantix | Change in Smoking Withdrawal Symptoms | Appetite -- % change 1 week from Quit Day | -10.53 percentage of change | Standard Error 3.148 |
| Chantix | Change in Smoking Withdrawal Symptoms | Respiratory -- % change 6 months from Quit Day | -65.87 percentage of change | Standard Error 3.293 |
| Chantix | Change in Smoking Withdrawal Symptoms | Arousal -- % change 11 weeks from Quit Day | 7.33 percentage of change | Standard Error 6.117 |
| Chantix | Change in Smoking Withdrawal Symptoms | Habit -- % change 1 week from Quit Day | -5.15 percentage of change | Standard Error 4.878 |
| Chantix | Change in Smoking Withdrawal Symptoms | Craving -- % change 7 weeks from Quit Day | -30.94 percentage of change | Standard Error 3.124 |
| Chantix | Change in Smoking Withdrawal Symptoms | Habit -- % change 3 weeks from Quit Day | -17.67 percentage of change | Standard Error 4.959 |
| Chantix | Change in Smoking Withdrawal Symptoms | Arousal -- % change 6 months from Quit Day | 19.80 percentage of change | Standard Error 15.516 |
| Chantix | Change in Smoking Withdrawal Symptoms | Habit -- % change 7 weeks from Quit Day | -14.46 percentage of change | Standard Error 6.666 |
| Chantix | Change in Smoking Withdrawal Symptoms | Appetite -- % change 3 weeks from Quit Day | -11.04 percentage of change | Standard Error 5.065 |
| Chantix | Change in Smoking Withdrawal Symptoms | Habit -- % change 11 weeks from Quit Day | -16.61 percentage of change | Standard Error 6.601 |
| Chantix | Change in Smoking Withdrawal Symptoms | Anxiety -- % change 1 week from Quit Day | -8.22 percentage of change | Standard Error 3.48 |
| Chantix | Change in Smoking Withdrawal Symptoms | Craving -- % change 1 week from Quit Day | -18.15 percentage of change | Standard Error 2.354 |
| Chantix | Change in Smoking Withdrawal Symptoms | Anxiety -- % change 3 weeks from Quit Day | -8.66 percentage of change | Standard Error 4.001 |
| Chantix | Change in Smoking Withdrawal Symptoms | Craving -- % change 11 weeks from Quit Day | -26.97 percentage of change | Standard Error 4.471 |
| Chantix | Change in Smoking Withdrawal Symptoms | Negative Affect -- % change 7 weeks from Quit Day | -10.16 percentage of change | Standard Error 2.885 |
| Chantix | Change in Smoking Withdrawal Symptoms | Habit -- % change 6 months from Quit Day | -56.97 percentage of change | Standard Error 4.807 |
| Chantix | Change in Smoking Withdrawal Symptoms | Craving -- % change 3 weeks from Quit Day | -27.06 percentage of change | Standard Error 3.52 |
| Chantix + Zyban | Change in Smoking Withdrawal Symptoms | Habit -- % change 6 months from Quit Day | -53.40 percentage of change | Standard Error 5.905 |
| Chantix + Zyban | Change in Smoking Withdrawal Symptoms | Craving -- % change 3 weeks from Quit Day | -28.64 percentage of change | Standard Error 4.439 |
| Chantix + Zyban | Change in Smoking Withdrawal Symptoms | Craving -- % change 7 weeks from Quit Day | -28.75 percentage of change | Standard Error 5.104 |
| Chantix + Zyban | Change in Smoking Withdrawal Symptoms | Craving -- % change 11 weeks from Quit Day | -30.82 percentage of change | Standard Error 5.201 |
| Chantix + Zyban | Change in Smoking Withdrawal Symptoms | Craving -- % change 6 months from Quit Day | -33.52 percentage of change | Standard Error 9.02 |
| Chantix + Zyban | Change in Smoking Withdrawal Symptoms | Negative Affect -- % change 1 week from Quit Day | -7.15 percentage of change | Standard Error 2.791 |
| Chantix + Zyban | Change in Smoking Withdrawal Symptoms | Negative Affect -- % change 3 weeks from Quit Day | -4.72 percentage of change | Standard Error 4.23 |
| Chantix + Zyban | Change in Smoking Withdrawal Symptoms | Negative Affect -- % change 7 weeks from Quit Day | -10.88 percentage of change | Standard Error 4.177 |
| Chantix + Zyban | Change in Smoking Withdrawal Symptoms | Negative Affect -- % change 11 weeks from Quit Day | -8.52 percentage of change | Standard Error 4.567 |
| Chantix + Zyban | Change in Smoking Withdrawal Symptoms | Negative Affect -- % change 6 months from Quit Day | 21.96 percentage of change | Standard Error 19.66 |
| Chantix + Zyban | Change in Smoking Withdrawal Symptoms | Appetite -- % change 1 week from Quit Day | -4.40 percentage of change | Standard Error 3.224 |
| Chantix + Zyban | Change in Smoking Withdrawal Symptoms | Appetite -- % change 3 weeks from Quit Day | -4.42 percentage of change | Standard Error 5.553 |
| Chantix + Zyban | Change in Smoking Withdrawal Symptoms | Appetite -- % change 7 weeks from Quit Day | -11.66 percentage of change | Standard Error 6.403 |
| Chantix + Zyban | Change in Smoking Withdrawal Symptoms | Appetite -- % change 11 weeks from Quit Day | -8.64 percentage of change | Standard Error 8.199 |
| Chantix + Zyban | Change in Smoking Withdrawal Symptoms | Appetite -- % change 6 months from Quit Day | -35.44 percentage of change | Standard Error 15.819 |
| Chantix + Zyban | Change in Smoking Withdrawal Symptoms | Arousal -- % change 1 week from Quit Day | 10.72 percentage of change | Standard Error 3.716 |
| Chantix + Zyban | Change in Smoking Withdrawal Symptoms | Arousal -- % change 3 weeks from Quit Day | -4.40 percentage of change | Standard Error 3.643 |
| Chantix + Zyban | Change in Smoking Withdrawal Symptoms | Arousal -- % change 7 weeks from Quit Day | -4.03 percentage of change | Standard Error 3.95 |
| Chantix + Zyban | Change in Smoking Withdrawal Symptoms | Arousal -- % change 11 weeks from Quit Day | -1.56 percentage of change | Standard Error 3.928 |
| Chantix + Zyban | Change in Smoking Withdrawal Symptoms | Arousal -- % change 6 months from Quit Day | 49.01 percentage of change | Standard Error 32.352 |
| Chantix + Zyban | Change in Smoking Withdrawal Symptoms | Anxiety -- % change 3 weeks from Quit Day | -14.40 percentage of change | Standard Error 3.517 |
| Chantix + Zyban | Change in Smoking Withdrawal Symptoms | Anxiety -- % change 7 weeks from Quit Day | -12.50 percentage of change | Standard Error 5 |
| Chantix + Zyban | Change in Smoking Withdrawal Symptoms | Anxiety -- % change 11 weeks from Quit Day | -19.83 percentage of change | Standard Error 3.768 |
| Chantix + Zyban | Change in Smoking Withdrawal Symptoms | Anxiety -- % change 6 months from Quit Day | -57.15 percentage of change | Standard Error 6.064 |
| Chantix + Zyban | Change in Smoking Withdrawal Symptoms | Gastrointestinal -- % change 1 week from Quit Day | -7.78 percentage of change | Standard Error 2.692 |
| Chantix + Zyban | Change in Smoking Withdrawal Symptoms | Gastrointestinal -- % change 3 weeks from Quit Day | -10.07 percentage of change | Standard Error 2.791 |
| Chantix + Zyban | Change in Smoking Withdrawal Symptoms | Gastrointestinal -- % change 7 weeks from Quit Day | -8.44 percentage of change | Standard Error 4.777 |
| Chantix + Zyban | Change in Smoking Withdrawal Symptoms | Gastrointestinal - % change 11 weeks from Quit Day | -9.60 percentage of change | Standard Error 3.897 |
| Chantix + Zyban | Change in Smoking Withdrawal Symptoms | Gastrointestinal - % change 6 months from Quit Day | -56.61 percentage of change | Standard Error 6.026 |
| Chantix + Zyban | Change in Smoking Withdrawal Symptoms | Respiratory -- % change 1 week from Quit Day | -7.47 percentage of change | Standard Error 2.887 |
| Chantix + Zyban | Change in Smoking Withdrawal Symptoms | Respiratory -- % change 3 weeks from Quit Day | -8.81 percentage of change | Standard Error 3.697 |
| Chantix + Zyban | Change in Smoking Withdrawal Symptoms | Respiratory -- % change 7 weeks from Quit Day | -18.04 percentage of change | Standard Error 4.12 |
| Chantix + Zyban | Change in Smoking Withdrawal Symptoms | Respiratory -- % change 11 weeks from Quit Day | -19.67 percentage of change | Standard Error 4.507 |
| Chantix + Zyban | Change in Smoking Withdrawal Symptoms | Respiratory -- % change 6 months from Quit Day | -55.77 percentage of change | Standard Error 6.618 |
| Chantix + Zyban | Change in Smoking Withdrawal Symptoms | Habit -- % change 1 week from Quit Day | 1.64 percentage of change | Standard Error 5.12 |
| Chantix + Zyban | Change in Smoking Withdrawal Symptoms | Habit -- % change 3 weeks from Quit Day | -16.07 percentage of change | Standard Error 3.735 |
| Chantix + Zyban | Change in Smoking Withdrawal Symptoms | Habit -- % change 7 weeks from Quit Day | -20.55 percentage of change | Standard Error 4.868 |
| Chantix + Zyban | Change in Smoking Withdrawal Symptoms | Habit -- % change 11 weeks from Quit Day | -24.78 percentage of change | Standard Error 6.085 |
| Chantix + Zyban | Change in Smoking Withdrawal Symptoms | Craving -- % change 1 week from Quit Day | -15.49 percentage of change | Standard Error 3.117 |
| Chantix + Zyban | Change in Smoking Withdrawal Symptoms | Anxiety -- % change 1 week from Quit Day | -12.26 percentage of change | Standard Error 2.78 |