Clinical trial NCT00063323: Maintenance Treatment for Abstinent Smokers
Official title: Maintenance Treatment for Prevention of Smoking Relapse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tobacco Use Disorder
Keywords: Maintenance treatment
Smoking relapse
Bupropion
Nicotine replacement
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: Research Foundation for Mental Hygiene, Inc.
First posted: 2003-07-01
Enrollment: 589
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Survival abstinence rate with maintenance treatment
timeFrame: 48 weeks after start of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: Research Foundation for Mental Hygiene, Inc.
name: Lirio S. S Covey, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Covey LS, Glassman AH, Jiang H, Fried J, Masmela J, LoDuca C, Petkova E, Rodriguez K. A randomized trial of bupropion and/or nicotine gum as maintenance treatment for preventing smoking relapse. Addiction. 2007 Aug;102(8):1292-302. doi: 10.1111/j.1360-0443.2007.01887.x.
citation: Covey LS, Botello-Harbaum M, Glassman AH, Masmela J, LoDuca C, Salzman V, Fried J. Smokers' response to combination bupropion, nicotine patch, and counseling treatment by race/ethnicity. Ethn Dis. 2008 Winter;18(1):59-64.
citation: Covey LS, Manubay J, Jiang H, Nortick M, Palumbo D. Smoking cessation and inattention or hyperactivity/impulsivity: a post hoc analysis. Nicotine Tob Res. 2008 Dec;10(12):1717-25. doi: 10.1080/14622200802443536.
citation: Covey LS, Weissman J, LoDuca C, Duan N. A comparison of abstinence outcomes among gay/bisexual and heterosexual male smokers in an intensive, non-tailored smoking cessation study. Nicotine Tob Res. 2009 Nov;11(11):1374-7. doi: 10.1093/ntr/ntp137. Epub 2009 Sep 24.