NCT00063323

Maintenance Treatment for Abstinent Smokers

Maintenance Treatment for Prevention of Smoking Relapse

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 589 (actual)
• Sponsor: National Institute on Drug Abuse (NIDA) · NIH
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Tobacco Use Disorder

Interventions

Type	Name	Description
DRUG	Bupropion

Timeline

• Start date: 2000-08-01
• Primary completion: 2006-07-01
• Completion: 2006-07-01
• First posted: 2003-07-01
• Last updated: 2017-01-12

Locations

1 site across 1 country: United States