Maintaining Abstinence in Chronic Cigarette Smokers - 1

Phase 2

Completed

• Conditions: Tobacco Use Disorder
• Interventions: Drug: Bupropion and NRT

• Registration Number: NCT00087880
• Lead Sponsor: National Institute on Drug Abuse (NIDA)

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.

Study Timeline

• Study Start: 2002-12
• Study First Submitted: 2004-07-15
• Study First Submitted QC: 2004-07-16
• Study First Posted: 2004-07-19
• Primary Completion: 2005-01
• Study Completion: 2009-09
• Status Verified: 2016-03
• Last Update Submitted: 2017-01-11
• Last Update Posted: 2017-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 407

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Extended Bupropion/Low Contact	Bupropion and NRT	Participants will receive the Brief Treatment followed by ongoing Bupropion treatment through Week 52. Participants will meet with medical staff once a month.
Extended Bupropion/High Contact	Bupropion and NRT	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.
Extended Placebo/Low Contact	Bupropion and NRT	Participants will receive the Brief Treatment followed by placebo medication (sugar-pill) through Week 52 and meet with medical staff once a month.
Brief Treatment	Bupropion and NRT	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.
Extended Placebo/High Contact	Bupropion and NRT	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.

Primary Outcome Measures

Name	Time	Method
Smoking Behavior	2

Trial Locations

Locations (1)

University California, San Francisco; 🇺🇸 San Francisco, California, United States