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Maintenance Treatment for Abstinent Smokers

Maintenance Treatment for Prevention of Smoking Relapse

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00063323
Enrollment
589
Registered
2003-07-01
Start date
2000-08-31
Completion date
2006-07-31
Last updated
2017-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tobacco Use Disorder

Keywords

Maintenance treatment, Smoking relapse, Bupropion, Nicotine replacement

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.

Interventions

DRUGBupropion

Sponsors

Research Foundation for Mental Hygiene, Inc.
CollaboratorOTHER
National Institute on Drug Abuse (NIDA)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Survival abstinence rate with maintenance treatment48 weeks after start of treatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026