Combination Pharmacotherapy for Smoking Cessation Among Methadone Patients

National Institutes of Health (NIH)

Status and phase

Completed

Phase 2

Conditions

Tobacco Use Disorder

Treatments

Other: Combined intervention

Study type

Interventional

Funder types

NIH

Identifiers

NCT00060814

K01-00450-2

NIDA-00450-2

Details and patient eligibility

About

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.

Full 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.

Enrollment

28 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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)