Combination Pharmacotherapy for Smoking Cessation Among Methadone Patients

This study has been completed.
Information provided by:
National Institute on Drug Abuse (NIDA) Identifier:
First received: May 14, 2003
Last updated: December 22, 2008
Last verified: December 2008

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 Intervention Phase
Tobacco Use Disorder
Other: Combined intervention
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study Examining the Effects of Combined Pharmacotherapy (Zyban/NRT)/Behavioral Treatment on Smoking Cessation Among MMT Patients.

Resource links provided by NLM:

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Behavioral [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of cigarettes smoked per day [ Time Frame: six months ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: June 2002
Study Completion Date: December 2002
Primary Completion Date: September 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Combined Pharmacotherapy and Counseling
300 mg Bupropion/4mg Nicotine Gum/Motivational Interviewing
Other: Combined intervention
300 mg bupropion plus 4mg nicotine gum ad lib plus motivational interviewing counseling

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.


Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts 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)
  Contacts and Locations
Please refer to this study by its identifier: NCT00060814

United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160 7420
Sponsors and Collaborators
Principal Investigator: Kimber Richter, Ph.D. University of Kansas
  More Information

No publications provided

Responsible Party: Kimber Richter, PhD, University of Kansas Medical Center Identifier: NCT00060814     History of Changes
Other Study ID Numbers: NIDA-00450-2, K01-00450-2
Study First Received: May 14, 2003
Last Updated: December 22, 2008
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Mental Disorders processed this record on April 17, 2014