Smoking Cessation in Alcoholism Treatment

May 18, 2010 updated by: Yale University

Field Study of Smoking Cessation in Alcoholism Treatment

This study is designed to increase understanding of the processes that affect the treatment outcome of individuals with both alcohol and nicotine dependence. Treatment outcome methodology will be combined with a computerized self-monitoring methodology to examine the extent to which smoking serves as a cue for alcohol craving and/or as a response to alcohol craving in treated alcoholics. Subjects will be veterans participating in the Substance Abuse Day Programs at the Newington and West Haven campuses of the VA Connecticut Healthcare System. Nonveteran women will be recruited from the community and enrolled in the day program. Subjects will be randomly assigned to one of the following two conditions: (1) intensive smoking cessation therapy (counseling plus nicotine replacement using nicotine patches) concurrent with alcohol treatment, or (2) brief smoking cessation advice concurrent with alcohol treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

112

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • West Haven, Connecticut, United States, 06516
        • Substance Abuse Treatment Center, VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Meets criteria for alcohol dependence within the past three months, and criteria for nicotine dependence.
  • Smoking at least 10 or more cigarettes per day for the past year.
  • Seeking treatment for both alcohol and nicotine dependence.
  • Minimum 1 week of alcohol abstinence and substance abuse day treatment attendance.
  • Willing to provide names of two individuals who can help locate the subject at follow-up.
  • Willing to provide name of one individual who can provide collateral information about alcohol and tobacco use.

Exclusion Criteria:

  • Other substance use disorder meeting criteria for dependence.
  • Acute medical or psychiatric disorder requiring inpatient treatment.
  • Taking medications known to influence alcohol urges (naltrexone, disulfiram).
  • Medical problems that would contraindicate nicotine patch use.
  • Allergy or hypersensitivity to nicotine or to adhesives used in transdermal delivery systems.
  • Use of other nicotine products such as cigars, pipes, or smokeless tobacco.
  • Severe generalized skin disorder.
  • Myocardial infarction within 3 months prior to study entry.
  • Unstable angina.
  • Pregnant or lactating females, or females who are not practicing a medically accepted form of contraception.
  • Impaired vision or hearing which would interfere with using a hand-held computer.
  • Reading ability below fifth grade level.
  • Lack of reliable transportation to the treatment site, or living more than 1 hour from treatment site.
  • Homeless or unstable residence.
  • Plan for future admission to residential treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion

August 1, 2002

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

November 2, 1999

First Posted (Estimate)

November 3, 1999

Study Record Updates

Last Update Posted (Estimate)

May 19, 2010

Last Update Submitted That Met QC Criteria

May 18, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIAAACOO11197
  • R01AA011197 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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