NCT00000457

Pharmacologic Relapse Prevention for Alcoholic Smokers

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 195 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Alcoholism
• Smoking

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 1998-06-01
• Primary completion: 2002-04-01
• Completion: 2007-08-01
• First posted: 1999-11-03
• Last updated: 2013-10-21

Locations

1 site across 1 country: United States