Pharmacologic Relapse Prevention for Alcoholic Smokers
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|ClinicalTrials.gov Identifier: NCT00000457|
Recruitment Status : Completed
First Posted : November 3, 1999
Last Update Posted : October 21, 2013
|Condition or disease||Intervention/treatment||Phase|
|Alcoholism Smoking||Drug: bupropion (Wellbutrin) Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||195 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Pharmacologic Relapse Prevention for Alcoholic Smokers|
|Study Start Date :||June 1998|
|Actual Primary Completion Date :||April 2002|
|Actual Study Completion Date :||August 2007|
Placebo Comparator: Placebo
Subjects who achieved smoking abstinence and give a bupropion-placebo (sugar) pill for 44 weeks in order to prevent relapse to smoking. Brief Behavioral Counseling is also given during this time.
placebo pill to match (look alike) the 150 mg pill of the bupropion given in the am for 3 days and then two pills (one in the morning and one at night) for the subsequent 44 mg.
Active Comparator: Bupropion
Subjects who achieved smoking abstinence and give bupropion (300 mg/day) for 44 weeks in order to prevent relapse to smoking. Brief Behavioral Counseling is also given during this time.
Drug: bupropion (Wellbutrin)
1 pill in the am of 150 mg of Bupropion
1 pill (150 mg) in the AM and one in the PM for a total of 300 mg per day for subsequent 44 weeks.
- Will bupropion reduce relapse to smoking compared to placebo [ Time Frame: 52 weeks and 76 weeks ]Determine if long-term use of bupropion will reduce the rate of relapse to smoking compared to placebo in recovering alcoholics who achieved initial abstinence from smoking with nicotine patch therapy projected to achieve 100% replacement.
- Does matching the dose of nicotine patches to nicotine levels help increase smoking abstinence [ Time Frame: 8 weeks ]Determine the week 8 smoking cessation rate in recovering alcoholics provided a nicotine patch dose projected to achieve 100% replacement.
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): NCT00000457
|United States, Minnesota|
|Mayo Clinic Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Richard D Hurt, MD||Mayo Clinic|