The purpose of this study is to determine the efficacy and cost-effectiveness of an intensive smoking cessation intervention that utilizes extended cognitive-behavioral therapy and combination nicotine replacement (CNR) in a randomized controlled trial. The intensive intervention will be compared to usual care involving referral to a free-standing smoking cessation program that provides brief counseling and CNR. We are recruiting 280 smokers, ages 18 to 75, who are enrolled in the Drug and Alcohol Treatment (DAT) programs at the San Francisco VA Medical Center (SFVAMC) and Santa Rosa VA Community-based Outpatient Clinic (CBOC). To be eligible, participants must be abstinent from alcohol for at least one week, but not more than 30 days. We will compare outcomes for the two study arms by assessing biochemically-validated point-prevalence smoking status at 3, 6, 9, and 12 months post-baseline and continuous abstinence over the 12-month follow-up. Expired-air carbon monoxide (CO) will be used to biochemically verify 7-day point prevalence abstinence. We will also conduct an economic analysis to determine the cost-effectiveness of the intensive intervention compared with usual care. We will also examine cross-relapse patterns during the follow-up period, assessing changes in mood states and use of tobacco, alcohol, and other drugs at 3, 6, 9, and 12 months.

Condition	Intervention	Phase
Tobacco Use Disorder alcohol & drug use	Behavior: Tobacco Use Cessation	Phase II Phase III

Further Study Details: 

Primary Outcomes: 7 day point prevalence of cigarette abstinence

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• at least 18 years of age
• alcohol as primary drug of abuse
• currently smoking at least 10 or more cigarettes
• abstinent from alcohol for at least 7 days and not more than 30 days
• self-reported interest in quitting smoking

Exclusion Criteria:

• any contraindications for nicotine patches or lozenges (e.g., unstable angina or recent myocardial infarction
• skin allergy to the nicotine patch
• severe cardiovascular disease
• lactation
• pregnancy by self-report or by positive serum pregnancy test in pre-menopausal women)
• unstable psychiatric disorder
• severe cognitive impairment

Please refer to this study by ClinicalTrials.gov identifier  NCT00217984

Timothy P Carmody, Ph.D.      (415)221-4810  Ext. 2344    carms@itsa.ucsf.edu

Maryland
      Addiction Treatment Services, Baltimore,  Maryland,  21224,  United States

Study chairs or principal investigators

Sharon M Hall, Ph.D.,  Principal Investigator,  University of California, San Francisco   

Study ID Numbers:  NIDA-09253-6; P50-09253-6
Last Updated:  September 21, 2005
Record first received:  September 16, 2005
ClinicalTrials.gov Identifier:  NCT00217984
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-09-27