Study of Bupropion Versus Bupropion + Naltrexone for Smoking Cessation
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|ClinicalTrials.gov Identifier: NCT00419731|
Recruitment Status : Unknown
Verified December 2009 by National Institute on Drug Abuse (NIDA).
Recruitment status was: Recruiting
First Posted : January 9, 2007
Last Update Posted : December 3, 2009
|Condition or disease||Intervention/treatment||Phase|
|Tobacco Use Disorder||Drug: Bupropion Drug: Bupropion + Naltrexone||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Phase II Randomized, Double-Blind Trial of Bupropion Versus Bupropion + Naltrexone for Smoking Cessation|
|Study Start Date :||November 2006|
|Estimated Primary Completion Date :||February 2010|
|Estimated Study Completion Date :||July 2010|
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.
- Biochemically-verified point-prevalence abstinence [ Time Frame: 7, 11, 16, and 30 weeks post-quit ]
- 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. ]
- Treatment completion. [ Time Frame: Weeks 7 and 30. ]
- Daily cigarette smoking rate. [ Time Frame: Weekly ]
- Frequency and severity of bupropion and naltrexone side effects. [ Time Frame: Weekly during treatment ]
- Attentional bias. [ Time Frame: Weeks 1, 3, and 7. ]
- Impulsivity. [ Time Frame: Weeks 1, 3, and 7. ]
- Nicotine withdrawal, craving and negative/positive affect. [ Time Frame: All visits. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00419731
|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|