search
Back to results

Intensive Intervention for Smokers - 6

Primary Purpose

Tobacco Use Disorder, Alcohol Dependence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Usual Care
Extended cognitive behavior therapy
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Use Disorder focused on measuring Tobacco use disorder, Alcohol dependence

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intensive intervention

Usual care

Arm Description

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

Referral to the smoking cessation clinic

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
September 16, 2005
Last Updated
October 30, 2017
Sponsor
University of California, San Francisco
Collaborators
National Institute on Drug Abuse (NIDA)
search

1. Study Identification

Unique Protocol Identification Number
NCT00217984
Brief Title
Intensive Intervention for Smokers - 6
Official Title
Intensive Intervention for Smokers in Alcohol Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder, Alcohol Dependence
Keywords
Tobacco use disorder, Alcohol dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
162 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intensive intervention
Arm Type
Experimental
Arm Description
Extended cognitive behavior therapy (16 sessions) plus nicotine patches and lozenges
Arm Title
Usual care
Arm Type
Other
Arm Description
Referral to the smoking cessation clinic
Intervention Type
Other
Intervention Name(s)
Usual Care
Other Intervention Name(s)
Smoking cessation clinic
Intervention Description
Referral to smoking cessation clinic
Intervention Type
Behavioral
Intervention Name(s)
Extended cognitive behavior therapy
Intervention Description
16 sessions of cognitive behavior therapy over 6 months
Primary Outcome Measure Information:
Title
7 day point prevalence of cigarette abstinence
Description
Participants are asked whether they smoked any cigarettes during the past seven days. Expired-air carbon monoxide is measured to validate abstinence.
Time Frame
Assessed at 3, 6, 9, and 12 months
Secondary Outcome Measure Information:
Title
Alcohol use
Description
Participants were asked to report use of alcohol during the past 90 days, using a timeline follow-back interview method
Time Frame
Assessed at 3, 6, 9, and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy Carmody, Ph.D.
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Intensive Intervention for Smokers - 6

We'll reach out to this number within 24 hrs