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Maintaining Abstinence in Chronic Cigarette Smokers - 1

Primary Purpose

Tobacco Use Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bupropion and NRT
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Use Disorder focused on measuring smoking cessation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Subjects (N=400) will be men and women (50%) over the age of 18 who smoke at least 10 cigarettes per day and answers yes to the question "Do you smoke within 30 minutes of arising?" Inclusion Criteria: -Subjects are age 18 and over, currently smoking 10 or more cigarettes per day, and report a smoking history of at least 5 years in response to the question "How long have you been a regular smoker?" Exclusion Criteria: History of seizure or head injury resulting in unconsciousness Any condition that might predispose to seizures (brain tumor or stroke) A current or history of anorexia nervosa or bulimia Any disease acutely life-threatening or so severe that the patient is judged unable to comply with the protocol Use of a protease inhibitor of MAO inhibitor within the last two week Current use of psychiatric drugs that would interfere with interpretation of study results, including antidepressants Treatment for alcohol dependence during the last year, or evidence of alcohol abuse so severe that the patient is judged potentially unable to comply with the protocol Patients who know they are leaving the Bay Area within the study period and non-English speakers will be excluded Suicidal or homicidal ideation Current major depression History of bipolar disorder Recent (within twelve months) myocardial infarction Any other medical condition that would contraindicate use of NRT or bupropion Physical limitation so severe that participation in a program of moderate exercise is not possible Pregnancy or lactation

Sites / Locations

  • University California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

Brief Treatment

Extended Bupropion/Low Contact

Extended Placebo/Low Contact

Extended Bupropion/High Contact

Extended Placebo/High Contact

Arm Description

Participants will start with a 21 mg nicotine patch, tapering to 14 mg patch and finally tapering to 7 mg patch. The nicotine patch will be administered on Week 3 of the program. Participants will meet with medical staff during Weeks 1, 2, 5, and 11. Five group counseling sessions must be attended by the participants. Assessments will be conducted on Weeks 12, 24, 36, 52, 64, and 104.

Participants will receive the Brief Treatment followed by ongoing Bupropion treatment through Week 52. Participants will meet with medical staff once a month.

Participants will receive the Brief Treatment followed by placebo medication (sugar-pill) through Week 52 and meet with medical staff once a month.

Participants will receive Brief Treatment followed by ongoing bupropion treatment through Week 52. Participants will attending counseling session 20-40 minutes in duration and will be scheduled at weeks 12, 14, 16, 18, 20, 24, 28, 32, 36, 44, and 52. The contents of these sessions will introduce additional information focusing on motivation, social support, mood management, weight gain, and dependence/withdrawal. Subjects will be contact by phone between counseling sessions (at Weeks 13, 15, 18, 22, 26, 30, 34, 36, 40, 48) for a brief check-in.

Participants receive the Brief Treatment followed by a placebo medication through Week 52 and meet with medical staff once per month. Participants will attending counseling session 20-40 minutes in duration and will be scheduled at weeks 12, 14, 16, 18, 20, 24, 28, 32, 36, 44, and 52. The contents of these sessions will introduce additional information focusing on motivation, social support, mood management, weight gain, and dependence/withdrawal. Subjects will be contact by phone between counseling sessions (at Weeks 13, 15, 18, 22, 26, 30, 34, 36, 40, 48) for a brief check-in.

Outcomes

Primary Outcome Measures

Smoking Behavior

Secondary Outcome Measures

Full Information

First Posted
July 15, 2004
Last Updated
January 11, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00087880
Brief Title
Maintaining Abstinence in Chronic Cigarette Smokers - 1
Official Title
Maintaining Abstinence in Chronic Cigarette Smokers
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
September 2009 (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 study is to evaluate the extended pharmacological and psychological treatment for chronic cigarette smokers.
Detailed Description
The work adapts interventions that have been successful in the general populations, and tailors them to chronic smokers, who may have numerous previous smoking treatment failures. If successful it will: (1) make available a treatment intervention that produces hight long term abstinence rates; (2) provide information on variables that predicts success and failure in this population of smokers; (3) examine the cost-effectiveness of more intensive, longer term treatments.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder
Keywords
smoking cessation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
407 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brief Treatment
Arm Type
Active Comparator
Arm Description
Participants will start with a 21 mg nicotine patch, tapering to 14 mg patch and finally tapering to 7 mg patch. The nicotine patch will be administered on Week 3 of the program. Participants will meet with medical staff during Weeks 1, 2, 5, and 11. Five group counseling sessions must be attended by the participants. Assessments will be conducted on Weeks 12, 24, 36, 52, 64, and 104.
Arm Title
Extended Bupropion/Low Contact
Arm Type
Active Comparator
Arm Description
Participants will receive the Brief Treatment followed by ongoing Bupropion treatment through Week 52. Participants will meet with medical staff once a month.
Arm Title
Extended Placebo/Low Contact
Arm Type
Placebo Comparator
Arm Description
Participants will receive the Brief Treatment followed by placebo medication (sugar-pill) through Week 52 and meet with medical staff once a month.
Arm Title
Extended Bupropion/High Contact
Arm Type
Active Comparator
Arm Description
Participants will receive Brief Treatment followed by ongoing bupropion treatment through Week 52. Participants will attending counseling session 20-40 minutes in duration and will be scheduled at weeks 12, 14, 16, 18, 20, 24, 28, 32, 36, 44, and 52. The contents of these sessions will introduce additional information focusing on motivation, social support, mood management, weight gain, and dependence/withdrawal. Subjects will be contact by phone between counseling sessions (at Weeks 13, 15, 18, 22, 26, 30, 34, 36, 40, 48) for a brief check-in.
Arm Title
Extended Placebo/High Contact
Arm Type
Placebo Comparator
Arm Description
Participants receive the Brief Treatment followed by a placebo medication through Week 52 and meet with medical staff once per month. Participants will attending counseling session 20-40 minutes in duration and will be scheduled at weeks 12, 14, 16, 18, 20, 24, 28, 32, 36, 44, and 52. The contents of these sessions will introduce additional information focusing on motivation, social support, mood management, weight gain, and dependence/withdrawal. Subjects will be contact by phone between counseling sessions (at Weeks 13, 15, 18, 22, 26, 30, 34, 36, 40, 48) for a brief check-in.
Intervention Type
Drug
Intervention Name(s)
Bupropion and NRT
Other Intervention Name(s)
Zyban
Intervention Description
All participants receive standard 12 week treatment of NRT, bupropion and five group counseling sessions. At week 11, subjects are randomly assigned to one of five treatment groups (1) Bupropion/Low Contact; (2) Placebo/Low Contact; (3) Bupropion/Relapse Prevention; (4) Placebo/Relapse Prevention; (5) No Further Treatment. Data is collected at Week 0, and at weeks 12, 24, 52, 64, and 104.
Primary Outcome Measure Information:
Title
Smoking Behavior
Time Frame
2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Subjects (N=400) will be men and women (50%) over the age of 18 who smoke at least 10 cigarettes per day and answers yes to the question "Do you smoke within 30 minutes of arising?" Inclusion Criteria: -Subjects are age 18 and over, currently smoking 10 or more cigarettes per day, and report a smoking history of at least 5 years in response to the question "How long have you been a regular smoker?" Exclusion Criteria: History of seizure or head injury resulting in unconsciousness Any condition that might predispose to seizures (brain tumor or stroke) A current or history of anorexia nervosa or bulimia Any disease acutely life-threatening or so severe that the patient is judged unable to comply with the protocol Use of a protease inhibitor of MAO inhibitor within the last two week Current use of psychiatric drugs that would interfere with interpretation of study results, including antidepressants Treatment for alcohol dependence during the last year, or evidence of alcohol abuse so severe that the patient is judged potentially unable to comply with the protocol Patients who know they are leaving the Bay Area within the study period and non-English speakers will be excluded Suicidal or homicidal ideation Current major depression History of bipolar disorder Recent (within twelve months) myocardial infarction Any other medical condition that would contraindicate use of NRT or bupropion Physical limitation so severe that participation in a program of moderate exercise is not possible Pregnancy or lactation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon M Hall, Ph.D.
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0984
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Maintaining Abstinence in Chronic Cigarette Smokers - 1

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