Combination Pharmacotherapy for Smoking Cessation Among Methadone Patients - Full Text View

Sponsor:	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	Other: Combined intervention	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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:

MedlinePlus related topics: Quitting Smoking Smoking

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
Combined Pharmacotherapy and Counseling: Experimental 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:	University of Kansas Medical Center ( Kimber Richter, PhD )
Study ID Numbers:	NIDA-00450-2, K01-00450-2
Study First Received:	May 14, 2003
Last Updated:	December 22, 2008
ClinicalTrials.gov Identifier:	NCT00060814 History of Changes
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Mental Disorders
Tobacco Use Disorder
Substance-Related Disorders
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on February 08, 2010