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Combination Pharmacotherapy for Smoking Cessation Among Methadone Patients

This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00060814
First received: May 14, 2003
Last updated: December 22, 2008
Last verified: December 2008
History of Changes
  Purpose

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:

Drug Information available for: Bupropion
U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00060814

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160 7420
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Kimber Richter, Ph.D. University of Kansas
  More Information

No publications provided

Responsible Party: Kimber Richter, PhD, University of Kansas Medical Center
ClinicalTrials.gov 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

ClinicalTrials.gov processed this record on May 21, 2013