Completed

Pharmacologic Relapse Prevention for Alcoholic Smokers

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Placebo

+ bupropion (Wellbutrin)

Drug
Who is being recruted

Behavior+4

+ Mental Disorders

+ Substance-Related Disorders

Over 18 Years
+19 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: June 1998
See protocol details

Summary

Principal SponsorMayo Clinic
Last updated: October 21, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 1998

Actual date on which the first participant was enrolled.

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.

NCT00000457
Principal SponsorMayo Clinic
Last updated: October 21, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

195 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorMental DisordersSubstance-Related DisordersAlcohol-Related DisordersChemically-Induced DisordersAlcoholismSmoking

Criteria

6 inclusion criteria required to participate
Can read and write English
General good health
Has a history of smoking 20 or more cigarettes per day for the prior year
Has provided written informed consent
Show More Criteria
13 exclusion criteria prevent from participating
A history of or current diagnosis of anorexia nervosa or bulimia
A predisposition to seizures
Active non- nicotine drug dependence
Current major depression. A past history of major depression will not be an exclusionary criteria
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

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.

Group II

Active Comparator
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Mayo Clinic Rochester

Rochester, United StatesOpen Mayo Clinic Rochester in Google Maps
CompletedOne Study Center