Maintenance Treatment for Abstinent Smokers

Study Overview
=================
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.

Official Title
-----------------
Maintenance Treatment for Prevention of Smoking Relapse

Conditions
-----------------
Tobacco Use Disorder

Intervention / Treatment
-----------------
* Drug: Bupropion


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival abstinence rate with maintenance treatment |  | 48 weeks after start of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Maintenance treatment, Smoking relapse, Bupropion, Nicotine replacement