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Completed

NCT Number: NCT00217984

Intensive Intervention for Smokers - 6

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.

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Key information

Conditions

Tobacco Use Disorder Alcohol Dependence Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Medical Center

San Francisco, California, 94121, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Usual Care

Other

Referral to smoking cessation clinic

Other names: Smoking cessation clinic

Extended cognitive behavior therapy

Behavioral

16 sessions of cognitive behavior therapy over 6 months

Primary outcomes

  1. 7 day point prevalence of cigarette abstinence

    Time frame: Assessed at 3, 6, 9, and 12 months

    Participants are asked whether they smoked any cigarettes during the past seven days. Expired-air carbon monoxide is measured to validate abstinence.

Secondary outcomes

  1. Alcohol use

    Time frame: Assessed at 3, 6, 9, and 12 months

    Participants were asked to report use of alcohol during the past 90 days, using a timeline follow-back interview method

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Intensive Intervention for Smokers in Alcohol Treatment

Important dates

Study start
2006
Primary completion
2009
Study completion
2010
First posted
Sep 22, 2005
Registry last updated
Nov 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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