Combination Pharmacotherapy for Smoking Cessation Among Methadone Patients

Pilot Study Examining the Effects of Combined Pharmacotherapy (Zyban/NRT)/Behavioral Treatment on Smoking Cessation Among MMT Patients.

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.

Study Overview

• Status: Completed
• Conditions: Tobacco Use Disorder
• Intervention / Treatment: Other: Combined intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160 7420
      • University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Behavioral	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of cigarettes smoked per day	six months

Collaborators and Investigators

• Sponsor: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Kimber Richter, Ph.D., University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2002
• Primary Completion (Actual): September 1, 2002
• Study Completion (Actual): December 1, 2002

Study Registration Dates

• First Submitted: May 14, 2003
• First Submitted That Met QC Criteria: May 14, 2003
• First Posted (Estimate): May 15, 2003

Study Record Updates

• Last Update Posted (Estimate): January 12, 2017
• Last Update Submitted That Met QC Criteria: January 11, 2017
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: NIDA-00450-2; K01-00450-2