NCT00217984

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
9 months until next milestone

Study Start

First participant enrolled

July 1, 2006

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

November 1, 2017

Status Verified

October 1, 2017

Enrollment Period

2.9 years

First QC Date

September 16, 2005

Last Update Submit

October 30, 2017

Conditions

Tobacco Use DisorderAlcohol Dependence

Keywords

Tobacco use disorderAlcohol dependence

Outcome Measures

Primary Outcomes (1)

  • 7 day point prevalence of cigarette abstinence

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

    Assessed at 3, 6, 9, and 12 months

Secondary Outcomes (1)

  • Alcohol use

    Assessed at 3, 6, 9, and 12 months

Study Arms (2)

Intensive intervention

EXPERIMENTAL

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

Behavioral: Extended cognitive behavior therapy

Usual care

OTHER

Referral to the smoking cessation clinic

Other: Usual Care

Interventions

Usual CareOTHER

Referral to smoking cessation clinic

Also known as: Smoking cessation clinic
Usual care
Extended cognitive behavior therapyBEHAVIORAL

16 sessions of cognitive behavior therapy over 6 months

Intensive intervention

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Medical Center

San Francisco, California, 94121, United States

Location

MeSH Terms

Conditions

Tobacco Use DisorderAlcoholism

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersAlcohol-Related Disorders

Study Officials

  • Timothy Carmody, Ph.D.

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2005

First Posted

September 22, 2005

Study Start

July 1, 2006

Primary Completion

June 1, 2009

Study Completion

June 1, 2010

Last Updated

November 1, 2017

Record last verified: 2017-10

Locations

US(1)