Maintenance Treatment for Abstinent Smokers

Phase 3

Completed

• Conditions: Tobacco Use Disorder
• Interventions: Drug: Bupropion

• Registration Number: NCT00063323
• Lead Sponsor: National Institute on Drug Abuse (NIDA)

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2000-08
• Study First Submitted: 2003-06-25
• Study First Submitted QC: 2003-06-30
• Study First Posted: 2003-07-01
• Primary Completion: 2006-07
• Study Completion: 2006-07
• Status Verified: 2010-01
• Last Update Submitted: 2017-01-11
• Last Update Posted: 2017-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 589

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bupropion	Bupropion	Bupropion (brand name Zyban Sustained Release). Participants used bupropion SR 150 mg twice daily during the 16-week maintenance treatment.
Nicotine gum	Bupropion	Nicotine gum (brand name Nicorette) During the maintenance 16-week maintenance treatment phase, participants assigned to this arm received 2 mg. nicotine gum.
Bupropion+Nicotine Gum	Bupropion	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.
Double placebo	Bupropion	Placebo gum + placebo pill. Identical placebo pill was used twice daily and identical placebo gum was used as needed.

Primary Outcome Measures

Name	Time	Method
Survival abstinence rate with maintenance treatment	48 weeks after start of treatment

Trial Locations

Locations (1)

New York State Psychiatric Institute; 🇺🇸 New York, New York, United States