Tobacco Use Disorder
Conditions
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.
Interventions
300 mg bupropion plus 4mg nicotine gum ad lib plus motivational interviewing counseling
Sponsors
National Institute on Drug Abuse (NIDA)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Behavioral | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Number of cigarettes smoked per day | six months |
Countries
United States
Outcome results
None listed