Combination Pharmacotherapy for Smoking Cessation Among Methadone Patients - Tabular View

Tracking Information

First Received Date ^ICMJE

May 14, 2003

Last Updated Date

December 22, 2008

Start Date ^ICMJE

June 2002

Primary Completion Date

September 2002 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Behavioral [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Behavioral

Change History

Complete list of historical versions of study NCT00060814 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Combination Pharmacotherapy for Smoking Cessation Among Methadone Patients

Official Title ^ICMJE

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

Brief 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.

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 Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Tobacco Use Disorder

Intervention ^ICMJE

Other: Combined intervention

Study Arms / Comparison Groups

Experimental: 300 mg Bupropion/4mg Nicotine Gum/Motivational Interviewing

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2002

Primary Completion Date

September 2002 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00060814

Responsible Party

Kimber Richter, PhD, University of Kansas Medical Center

Study ID Numbers ^ICMJE

NIDA-00450-2, K01-00450-2

Study Sponsor ^ICMJE

National Institute on Drug Abuse (NIDA)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Kimber Richter, Ph.D.

University of Kansas

Information Provided By

National Institute on Drug Abuse (NIDA)

Verification Date

December 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP