Effect of Combined Pharmacotherapy/Behavioral Treatment on Smoking Cessation For Methadone Maintenance Therapy Patients - 2 - Full Text View

Effect of Combined Pharmacotherapy/Behavioral Treatment on Smoking Cessation For Methadone Maintenance Therapy Patients - 2

This study is ongoing, but not recruiting participants.

Sponsored by:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00060814

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	Behavioral: Bupropion	Phase II

MedlinePlus related topics:

Quitting Smoking Smoking

Drug Information available for:

Methadone Methadone hydrochloride Bupropion hydrochloride Bupropion

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Active Control

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

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

Primary Outcome Measures:

Behavioral

Estimated Enrollment:	34
Study Start Date:	September 2002

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

Study ID Numbers:	NIDA-00450-2, K01-00450-2
First Received:	May 14, 2003
Last Updated:	November 3, 2005
ClinicalTrials.gov Identifier:	NCT00060814
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Methadone

Smoking

Mental Disorders

Tobacco Use Disorder

Bupropion

Substance-Related Disorders

Disorders of Environmental Origin

ClinicalTrials.gov processed this record on November 30, 2008