Maintenance Treatment for Abstinent Smokers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

589 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-08-31

Study Completion Date

2006-07-31

Brief Summary

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The purpose of this study is to determine the efficacy and cost-effectiveness of long-term pharmacotherapy (using Zyban and/or nicotine replacement) for reducing the relapse rate associated with stopping smoking.

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Detailed Description

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The goal of this study was to assess relapse prevention outcomes among individuals able to stop smoking when pharmacotherapy is extended beyond the standard duration of treatment. We hypothesized that maintenance treatment with prolonged bupropion use and/or "as needed" use of nicotine gum will reduce relapse to smoking. Participants were recruited through advertisements on radio, television, newspapers, the Internet, and various community outlets. Respondents were pre-screened by telephone using a standard interview. The first participant entered the OLT phase in February 2001; the final NTFU visit took place in October 2005.

The study was multi-phased consisting of: 1) eight-week open-label treatment (OLT) with bupropion and nicotine patch; 2) randomized double-blind assignment of OLT successes to 16 weeks of placebo-controlled maintenance treatment (MT); and 3) 24 weeks of non-treatment follow-up (NTFU). Participants received $25 compensation for completing the NTFU visits at Weeks 36 and 48. The Institutional Review Board of the New York State Psychiatric Institute approved the study. The study was performed at the Columbia University Medical Center Smoking Cessation Clinic in New York City.

Conditions

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Tobacco Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Bupropion

Bupropion (brand name Zyban Sustained Release). Participants used bupropion SR 150 mg twice daily during the 16-week maintenance treatment.

Group Type ACTIVE_COMPARATOR

Bupropion

Intervention Type DRUG

Nicotine gum

Nicotine gum (brand name Nicorette) During the maintenance 16-week maintenance treatment phase, participants assigned to this arm received 2 mg. nicotine gum.

Group Type ACTIVE_COMPARATOR

Bupropion

Intervention Type DRUG

Bupropion+Nicotine Gum

Combined active treatments: Bupropion (Zyban SR) and nicotine gum (Nicorette). Participants were instructed to use the 150 mg bupropion pill twice daily and the 2 mg. gum as needed during the 16-week maintenance treatment phase.

Group Type ACTIVE_COMPARATOR

Bupropion

Intervention Type DRUG

Double placebo

Placebo gum + placebo pill. Identical placebo pill was used twice daily and identical placebo gum was used as needed.

Group Type PLACEBO_COMPARATOR

Bupropion

Intervention Type DRUG

Interventions

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Bupropion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients who smoke at least 10 cigarettes daily and have attempted to quit smoking at least once

Exclusion Criteria

* Seizure History
* Unstable Blood Pressure
* Current major depression
* Current alcohol/drug abuse or dependency
* Lifetime psychotic illness
* Current use of psychotropic drugs
* Unstable medical condition

Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes