Alcohol-Related Disorders, Smoking Cessation
Conditions
Brief summary
Smoking is often a problem for alcohol dependent individuals. Many people who seek treatment for alcohol dependence are unable to quit smoking. The purpose of this study is to evaluate the effectiveness of bupropion, an antidepressant medication, in treating smokers receiving treatment for alcohol dependence.
Detailed description
Past research suggests that over 75% of alcohol dependent individuals in early alcohol recovery smoke cigarettes; smoking-related mortality exceeds alcohol-related mortality in this population. Many alcohol dependent individuals in early recovery are interested in smoking cessation treatment; however, studies indicate that these smokers find it very difficult to quit smoking. More effective treatment methods are needed for smokers in early alcohol recovery. Bupropion is a dopaminergic antidepressant that may be effective in treating nicotine dependent individuals. The purpose of this study is to evaluate the effectiveness of bupropion in nicotine dependent individuals receiving treatment for alcohol dependence. In addition, this study will investigate the psychological mechanisms that may mediate the efficacy of bupropion in smoking cessation. We will also collect DNA from subjects in order to explore whether response to bupropion is mediated by particular genetic variants in the dopaminergic, metabolic and nicotinic receptor systems of smokers. Participants will be randomly assigned to receive either 300 mg of bupropion or placebo, daily for 8 weeks. In addition, all participants will receive a nicotine patch for 7 weeks. This will consist of a 21-mg nicotine patch for 4 weeks, a 14-mg nicotine patch for 2 weeks, and a 7-mg nicotine patch for 1 week. All participants will undergo seven counseling sessions. Follow-up visits will occur at Weeks 7, 12, and 24. Pre-quit variables (e.g., smoking satisfaction) and three post-quit variables (craving, nicotine withdrawal, and negative effects) will be evaluated at all study visits.
Interventions
DRUGBupropion
300 mg QD
DRUGplacebo
placebo
Sponsors
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Smokes a minimum of 10 cigarettes daily for at least 1 year prior to study entry * Abstinence from alcohol and other non-nicotine drugs for between 1 and 12 months at time of study entry * Meets criteria for alcohol dependence or abuse in the 12 months prior to study entry
Exclusion criteria
* History of seizures, head trauma and/or severe hepatic cirrhosis * Current use of medications known to affect smoking behavior and/or cessation * Use of tricyclic antidepressant medication and monoamine oxidase inhibitors * Major depressive disorder within the month prior to study entry * Eating disorder within the year prior to study entry * History of bipolar or psychotic disorder * Pregnant or breastfeeding * Unstable serious medical disorder * History of migraines * Currently using smokeless tobacco, pipes, or cigars
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Smoking Abstinence | week 7, week 11 and week 24 after scheduled quit day | The number of subjects in each treatment group who were smoking abstinent (7-day point prevalence) at week 7 (end of treatment), week 11 and week 24. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bupropion 300-mg Capsules participants in this arm receive bupropion
Bupropion: 300 mg QD | 73 |
| Placebo placebo
placebo: placebo | 70 |
| Total | 143 |
Baseline characteristics
| Characteristic | Bupropion 300-mg Capsules | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 49.2 years STANDARD_DEVIATION 7.5 | 48.6 years STANDARD_DEVIATION 9 | 47.8 years STANDARD_DEVIATION 10.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 20 Participants | 36 Participants | 16 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 53 Participants | 107 Participants | 54 Participants |
| Region of Enrollment United States | 73 participants | 143 participants | 70 participants |
| Sex: Female, Male Female | 15 Participants | 26 Participants | 11 Participants |
| Sex: Female, Male Male | 58 Participants | 117 Participants | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 73 | 2 / 70 |
| serious Total, serious adverse events | 0 / 73 | 0 / 70 |
Outcome results
Primary
Smoking Abstinence
The number of subjects in each treatment group who were smoking abstinent (7-day point prevalence) at week 7 (end of treatment), week 11 and week 24.
Time frame: week 7, week 11 and week 24 after scheduled quit day
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bupropion 300-mg Capsules | Smoking Abstinence | week 7 | 19 participants |
| Bupropion 300-mg Capsules | Smoking Abstinence | week 11 | 12 participants |
| Bupropion 300-mg Capsules | Smoking Abstinence | week 24 | 6 participants |
| Placebo | Smoking Abstinence | week 7 | 21 participants |
| Placebo | Smoking Abstinence | week 11 | 9 participants |
| Placebo | Smoking Abstinence | week 24 | 11 participants |