Expired Study
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New York, New York 10032


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.

Study summary:

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.


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



Primary Contact:

Principal Investigator
Lirio S. S Covey, Ph.D.
Research Foundation for Mental Hygiene, Inc.

Backup Contact:


Location Contact:

New York, New York 10032
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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