Maintenance Treatment for Abstinent Smokers

Tobacco Use Disorder Clinical Trial

Official title:

Maintenance Treatment for Prevention of Smoking Relapse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00063323
• Other study ID #: NIDA-13490-1
• Secondary ID: R01DA013490DPMC
• Status: Completed
• Phase: Phase 3
• First received: June 25, 2003
• Last updated: January 11, 2017
• Start date: August 2000
• Est. completion date: July 2006

Study information

• Verified date: January 2010
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 589
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tobacco Use Disorder

Intervention

Drug:
• Bupropion

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival abstinence rate with maintenance treatment		48 weeks after start of treatment	No