Maintenance Treatment for Abstinent Smokers
| Status: | Completed |
|---|---|
| Conditions: | Smoking Cessation, Tobacco Consumers |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 21 - 75 |
| Updated: | 1/13/2017 |
| Start Date: | August 2000 |
| End Date: | July 2006 |
Maintenance Treatment for Prevention of Smoking Relapse
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.
pharmacotherapy (using Zyban and/or nicotine replacement) for reducing the relapse rate
associated with stopping smoking.
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.
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
We found this trial at
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New York State Psychiatric Institute The New York State Psychiatric Institute (NYSPI), established in 1895,...
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