Completed

Field Study of Smoking Cessation in Alcoholism Treatment

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What is being tested

nicotine replacement patch

Drug
Who is being recruted

Behavior+4

+ Mental Disorders

+ Substance-Related Disorders

Over 21 Years
+21 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
See protocol details

Summary

Principal SponsorYale University
Last updated: May 19, 2010
Sourced from a government-validated database.Claim as a partner

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.

NCT00000454
Principal SponsorYale University
Last updated: May 19, 2010
Sourced from a government-validated database.Claim as a partner

Protocol

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

112 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 21 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorMental DisordersSubstance-Related DisordersAlcohol-Related DisordersChemically-Induced DisordersAlcoholismSmoking

Criteria

6 inclusion criteria required to participate
Meets criteria for alcohol dependence within the past three months, and criteria for nicotine dependence
Minimum 1 week of alcohol abstinence and substance abuse day treatment attendance
Seeking treatment for both alcohol and nicotine dependence
Smoking at least 10 or more cigarettes per day for the past year
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15 exclusion criteria prevent from participating
Acute medical or psychiatric disorder requiring inpatient treatment
Allergy or hypersensitivity to nicotine or to adhesives used in transdermal delivery systems
Homeless or unstable residence
Impaired vision or hearing which would interfere with using a hand-held computer
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Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Substance Abuse Treatment Center, VA Medical Center

West Haven, United StatesOpen Substance Abuse Treatment Center, VA Medical Center in Google Maps
CompletedOne Study Center