The purpose of this pilot study is to examine the effects of combined pharmacotherapy (Zyban/NRT)/behavioral treatment on smoking cessation among methadone maintenance therapy patients.

Condition	Treatment or Intervention	Phase
Tobacco Use Disorder	Behavior: Bupropion	Phase II

This is a one-arm, open label pilot study of MMT patients to determine whether bupropion, nicotine replacement therapy, and behavioral counseling is a feasible and potentially effective intervention for smoking cessation. The smoking behaviors of participants will be be followed for 6 months post quit-date to determine effect-size estimates for a future, large scale trial.

Ages Eligible for Study:  18 Years   -   70 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Patients in long-term methadone maintenance treatment
• Patient smokes at least 10 cigarettes per day, are stable on their use of methadone (phase 2 or higher treatment), smoked for at least 1 year, be willing to participate for 6 months, and not have used bupropion or nicotine replacement therapy for 6 months

Exclusion Criteria:

• Patients who use prescription drug regimens that might affect methadone or bupropion metabolism
• Patients with cardiovascular disease, asthma, COPD
• Patients who are pregnant or breastfeeding
• Patients with regular use of alcohol, other illicit drugs, or other types of tobacco (chewing or pipe for example)

Robert Mccool, M.S.      (913)588-2502    rmccool@kumc.edu

Kansas
      University of Kansas Medical Center, Kansas City,  Kansas,  66160 7420,  United States; Recruiting

Study chairs or principal investigators

Kimber Richter, Ph.D.,  Principal Investigator,  University of Kansas   

Study ID Numbers:  NIDA-00450-2; K01-00450-2
Record last reviewed:  June 2004
Record first received:  May 14, 2003
ClinicalTrials.gov Identifier:  NCT00060814
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-08