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Intensive Intervention for Smokers - 6

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00217984
First received: September 16, 2005
Last updated: June 25, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Tobacco Use Disorder
Alcohol Dependence
 Other: Usual Care
Behavioral: Extended cognitive behavior therapy
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intensive Intervention for Smokers in Alcohol Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 7 day point prevalence of cigarette abstinence [ Time Frame: Assessed at 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]
    Participants are asked whether they smoked any cigarettes during the past seven days. Expired-air carbon monoxide is measured to validate abstinence.


Secondary Outcome Measures:
  • Alcohol use [ Time Frame: Assessed at 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]
    Participants were asked to report use of alcohol during the past 90 days, using a timeline follow-back interview method


Enrollment: 162
Study Start Date: July 2006
Study Completion Date: June 2010
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intensive intervention
16 sessions of cognitive behavior therapy plus nicotine patches and lozenges
 Behavioral: Extended cognitive behavior therapy
16 sessions of cognitive behavior therapy over 6 months
Other Name: Extended cognitive behavior therapy
Usual care
Referral to the smoking cessation clinic
 Other: Usual Care
Referral to smoking cessation clinic
Other Name: Smoking cessation clinic

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00217984

Locations
United States, California
VA Medical Center
San Francisco, California, United States, 94121
Sponsors and Collaborators
University of California, San Francisco
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Timothy Carmody, Ph.D. University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00217984     History of Changes
Other Study ID Numbers: NIDA-09253-6, P50DA009253
Study First Received: September 16, 2005
Last Updated: June 25, 2012
Health Authority: United States: Federal Government

Keywords provided by University of California, San Francisco:
Tobacco use disorder
Alcohol dependence

Additional relevant MeSH terms:
Alcoholism
Tobacco Use Disorder
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 21, 2013