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| Sponsor: | Mayo Clinic |
|---|---|
| Collaborator: |
National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
| Information provided by: | Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00000457 |
Purpose
This study will compare the long-term use of bupropion (Wellbutrin) and placebo for reducing the rate of smoking relapse in recovering alcoholics who achieved initial abstinence from smoking with nicotine patch therapy. The study will also determine the cessation rate in the 8th week of treatment among recovering alcoholics using a nicotine patch. The patch dose is projected to serve as a 100-percent replacement.
| Condition | Intervention | Phase |
|---|---|---|
|
Alcoholism Smoking |
Drug: bupropion (Wellbutrin) Drug: Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Pharmacologic Relapse Prevention for Alcoholic Smokers |
| Enrollment: | 195 |
| Study Start Date: | June 1998 |
| Study Completion Date: | August 2007 |
| Primary Completion Date: | April 2002 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
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Drug: Placebo
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.
Other Names:
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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.
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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. Other Names:
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The purpose of this trial was to recruit 292 recovering alcoholic smokers (abstinent from alcohol for a minimum of 1 year), who want to stop smoking and provide them with 100% nicotine replacement. The 100% nicotine replacement will be undertaken using a nicotine patch. By measuring their nicotine levels at study entry we can determine the patch dosing needed. The patch dosing will vary from 22 mg to 44 mg. Those who are able to achieve tobacco abstinence by week 8 will enter a relapse prevention phase for the remaining 44 weeks. In this phase, they will be randomized to active or placebo bupropion (300 mg/day). After 44 weeks of the relapse prevention trial (at week 52 of study participation), they will enter a post medication follow up for 6 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Richard D. Hurt, MD, Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00000457 History of Changes |
| Other Study ID Numbers: | 972-95, R01AA011219 |
| Study First Received: | November 2, 1999 |
| Last Updated: | April 27, 2010 |
| Health Authority: | United States: Federal Government |
|
Alcoholism Smoking Alcohol-Related Disorders Substance-Related Disorders Mental Disorders Habits Bupropion Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs |
Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs |