Smoking Cessation in Alcoholism Treatment

NCT ID: NCT00000454

Last Updated: 2010-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2002-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Alcoholism Smoking

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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nicotine replacement patch

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Locations

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Substance Abuse Treatment Center, VA Medical Center

West Haven, Connecticut, United States

Site Status

Countries

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United States

References

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Cooney NL, Litt MD, Cooney JL, Pilkey DT, Steinberg HR, Oncken CA. Concurrent brief versus intensive smoking intervention during alcohol dependence treatment. Psychol Addict Behav. 2007 Dec;21(4):570-5. doi: 10.1037/0893-164X.21.4.570.

Reference Type RESULT
PMID: 18072840 (View on PubMed)

Cooney NL, Litt MD, Cooney JL, Pilkey DT, Steinberg HR, Oncken CA. Alcohol and tobacco cessation in alcohol-dependent smokers: analysis of real-time reports. Psychol Addict Behav. 2007 Sep;21(3):277-86. doi: 10.1037/0893-164X.21.3.277.

Reference Type RESULT
PMID: 17874878 (View on PubMed)

Other Identifiers

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R01AA011197

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIAAACOO11197

Identifier Type: -

Identifier Source: org_study_id

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