Intensive Intervention for Smokers - 6

NCT ID: NCT00217984

Last Updated: 2017-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2010-06-30

Brief Summary

The purpose of this study was 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 was compared to usual care involving referral to a free-standing smoking cessation program that provides brief counseling and CNR. We recruited 162 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 had to be abstinent from alcohol for at least one week, but not more than 30 days. We compared 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) was used to biochemically verify 7-day point prevalence abstinence. We also conducted an economic analysis to determine the cost-effectiveness of the intensive intervention compared with usual care. We also examined 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.

Detailed Description

Introduction. The purpose of this study was to investigate the efficacy of an intensive tobacco cessation intervention for alcohol-dependent smokers in early recovery.

Methods. A total of 162 alcohol-dependent smokers were randomized to either intensive intervention for smoking cessation or usual care. The intensive intervention consisted of 16 sessions of individual cognitive behavior therapy (CBT) and combination nicotine replacement therapy that lasted 26 weeks. Usual care involved referral to a free-standing smoking cessation program that provided smoking cessation counseling of varying duration and guideline-concordant medications. The primary cessation outcome was verified 7-day point prevalence abstinence (PPA) at 12, 26, 38, and 52 weeks.

Results. At 12 and 26 weeks, the verified 7-day point-prevalence quit rate was significantly higher for the intensive intervention group than for the usual care group (both p = .03). However, the quit rates for the two treatment groups were not significantly different at 38 or 52 weeks. Verified 30-day alcohol abstinence rates were not significantly different for the two treatment groups at any of the follow-up assessments.

Conclusions. The intensive smoking cessation intervention yielded a higher short-term smoking quit rate without jeopardizing sobriety. A chronic care model might facilitate maintenance of smoking cessation during the first year of alcohol treatment and perhaps for longer periods of time. It is hoped that studies such as this will inform the development of more effective interventions for concurrent alcohol and tobacco use disorders.

Conditions

Tobacco Use Disorder; Alcohol Dependence

Keywords

Tobacco use disorder; Alcohol dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intensive intervention

Extended cognitive behavior therapy (16 sessions) plus nicotine patches and lozenges

Group Type: EXPERIMENTAL

Extended cognitive behavior therapy

Intervention Type: BEHAVIORAL

16 sessions of cognitive behavior therapy over 6 months

Usual care

Referral to the smoking cessation clinic

Group Type: OTHER

Usual Care

Intervention Type: OTHER

Referral to smoking cessation clinic

Interventions

Usual Care

Referral to smoking cessation clinic

Intervention Type: OTHER

Extended cognitive behavior therapy

16 sessions of cognitive behavior therapy over 6 months

Intervention Type: BEHAVIORAL

Other Intervention Names

Smoking cessation clinic

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timothy Carmody, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

VA Medical Center

San Francisco, California, United States

Countries

United States

Other Identifiers

P50DA009253

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIDA-09253-6

Identifier Type: -

Identifier Source: org_study_id