Combination Pharmacotherapy for Smoking Cessation Among Methadone Patients
Phase 2
Completed
- Conditions
- Tobacco Use Disorder
- Interventions
- Other: Combined intervention
- Registration Number
- NCT00060814
- Lead Sponsor
- National Institute on Drug Abuse (NIDA)
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Combined Pharmacotherapy and Counseling Combined intervention 300 mg Bupropion/4mg Nicotine Gum/Motivational Interviewing
- Primary Outcome Measures
Name Time Method Behavioral 6 months
- Secondary Outcome Measures
Name Time Method Number of cigarettes smoked per day six months
Trial Locations
- Locations (1)
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States