Study of Bupropion Versus Bupropion + Naltrexone for Smoking Cessation
Recruitment status was Recruiting
The purpose of this study is to compare the effects of bupropion + placebo to bupropion + naltrexone as treatments to help smokers quit.
Tobacco Use Disorder
Drug: Bupropion + Naltrexone
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Phase II Randomized, Double-Blind Trial of Bupropion Versus Bupropion + Naltrexone for Smoking Cessation|
- Biochemically-verified point-prevalence abstinence [ Time Frame: 7, 11, 16, and 30 weeks post-quit ] [ Designated as safety issue: No ]
- Likelihood of progression to a relapse (e.g., return to baseline smoking) following a slip at any time in study. [ Time Frame: At any point following the quit date. ] [ Designated as safety issue: No ]
- Treatment completion. [ Time Frame: Weeks 7 and 30. ] [ Designated as safety issue: No ]
- Daily cigarette smoking rate. [ Time Frame: Weekly ] [ Designated as safety issue: No ]
- Frequency and severity of bupropion and naltrexone side effects. [ Time Frame: Weekly during treatment ] [ Designated as safety issue: Yes ]
- Attentional bias. [ Time Frame: Weeks 1, 3, and 7. ] [ Designated as safety issue: No ]
- Impulsivity. [ Time Frame: Weeks 1, 3, and 7. ] [ Designated as safety issue: No ]
- Nicotine withdrawal, craving and negative/positive affect. [ Time Frame: All visits. ] [ Designated as safety issue: No ]
|Study Start Date:||November 2006|
|Estimated Study Completion Date:||July 2010|
|Estimated Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Sustained-release, 150 mg, q.d., for days 1-3, 150 mg, b.i.d., for balance of 7 weeks.
Placebo, 25 mg, q.d., for 7 weeks.
Drug: Bupropion + Naltrexone
Bupropion, Sustained-release, 150 mg, q.d., for days 1-3, 150 mg, b.i.d., for balance of 7 weeks.
Naltrexone, 25 mg, q.d., for 7 weeks.
The purpose of this study is to compare the effects of bupropion + placebo to bupropion + naltrexone as treatments to help smokers quit. Bupropion is an FDA-approved medication for smoking cessation that is believed to provide relief from craving and withdrawal through promotion of two neurotransmitter chemicals, dopamine and noradrenaline. Naltrexone is an FDA-approved medication for the treatment of opiate and alcohol dependence, that appears to function through blocking certain opiate receptors in the brain. It is expected that bupropion + naltrexone will produce higher smoking quit rates than bupropion + placebo. Bupropion alone is effective in alleviating some nicotine withdrawal complaints and craving for nicotine. However, bupropion does not reduce the rewarding effects of slips to smoking. Naltrexone alone is not generally effective as a smoking cessation medication, but it does help to reduce the rewarding effects of slips to smoking. Thus, it may help to prevent full relapse to smoking. In addition, naltrexone can help to reduce craving for cigarettes. It is hypothesized that the differing complementary actions of the two drugs will help smokers more than bupropion alone. In addition to examining smoking quit rates, the proposed study will also look at psychological processes that change during smoking cessation including, nicotine withdrawal, nicotine craving, mood, impulsivity, and attention
|Contact: Marc E Mooney, Ph.D.||firstname.lastname@example.org|
|Contact: Dorothy K Hatsukami, Ph.D.||email@example.com|
|United States, Minnesota|
|Tobacco Use Research Center, University of Minnesota||Recruiting|
|Minneapolis, Minnesota, United States, 55414|
|Contact: Marc E Mooney, Ph.D. 612-273-9732 firstname.lastname@example.org|
|Principal Investigator: Marc E Mooney, Ph.D.|
|Principal Investigator:||Marc E Mooney, Ph.D.||Univerisity of Minnesota|