Back to resultsCombination Pharmacotherapy for Smoking Cessation Among Methadone Patients
Primary Purpose
Tobacco Use Disorder
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Combined intervention
Sponsored by
About this trial
This is an interventional treatment trial for Tobacco Use Disorder
Eligibility 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)
Sites / Locations
- University of Kansas Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Combined Pharmacotherapy and Counseling
Arm Description
300 mg Bupropion/4mg Nicotine Gum/Motivational Interviewing
Outcomes
Primary Outcome Measures
Behavioral
Secondary Outcome Measures
Number of cigarettes smoked per day
Full Information
NCT ID
NCT00060814
First Posted
May 14, 2003
Last Updated
January 11, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00060814
Brief Title
Combination Pharmacotherapy for Smoking Cessation Among Methadone Patients
Official Title
Pilot Study Examining the Effects of Combined Pharmacotherapy (Zyban/NRT)/Behavioral Treatment on Smoking Cessation Among MMT Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
September 2002 (Actual)
Study Completion Date
December 2002 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Combined Pharmacotherapy and Counseling
Arm Type
Experimental
Arm Description
300 mg Bupropion/4mg Nicotine Gum/Motivational Interviewing
Intervention Type
Other
Intervention Name(s)
Combined intervention
Intervention Description
300 mg bupropion plus 4mg nicotine gum ad lib plus motivational interviewing counseling
Primary Outcome Measure Information:
Title
Behavioral
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of cigarettes smoked per day
Time Frame
six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimber Richter, Ph.D.
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160 7420
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Combination Pharmacotherapy for Smoking Cessation Among Methadone Patients
We'll reach out to this number within 24 hrs