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Combination Pharmacotherapy for Smoking Cessation Among Methadone Patients

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ClinicalTrials.gov Identifier: NCT00060814
Recruitment Status : Completed
First Posted : May 15, 2003
Last Update Posted : January 12, 2017
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)

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.

Condition or disease Intervention/treatment Phase
Tobacco Use Disorder Other: Combined intervention Phase 2

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  (Clinical Trial)
Actual Enrollment : 28 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study Examining the Effects of Combined Pharmacotherapy (Zyban/NRT)/Behavioral Treatment on Smoking Cessation Among MMT Patients.
Study Start Date : June 2002
Primary Completion Date : September 2002
Study Completion Date : December 2002

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Behavioral [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Number of cigarettes smoked per day [ Time Frame: six months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Medical Center

Responsible Party: Kimber Richter, PhD, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT00060814     History of Changes
Other Study ID Numbers: NIDA-00450-2
K01-00450-2
First Posted: May 15, 2003    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: October 2016

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders