Combination Pharmacotherapy for Smoking Cessation Among Methadone Patients

Tobacco Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00060814
• Other study ID #: NIDA-00450-2
• Secondary ID: K01-00450-2
• Status: Completed
• Phase: Phase 2
• First received: May 14, 2003
• Last updated: January 11, 2017
• Start date: June 2002
• Est. completion date: December 2002

Study information

• Verified date: October 2016
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 2002
• Est. primary completion date: September 2002
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tobacco Use Disorder

Intervention

Other:
• Combined intervention
300 mg bupropion plus 4mg nicotine gum ad lib plus motivational interviewing counseling

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Behavioral		6 months	No
Secondary	Number of cigarettes smoked per day		six months	No