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Smoking Cessation in Alcoholism Treatment

Primary Purpose

Alcoholism, Smoking

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
nicotine replacement patch
Sponsored by
Yale University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholism

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Substance Abuse Treatment Center, VA Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
May 18, 2010
Sponsor
Yale University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00000454
Brief Title
Smoking Cessation in Alcoholism Treatment
Official Title
Field Study of Smoking Cessation in Alcoholism Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Yale University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism, Smoking

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
nicotine replacement patch

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Substance Abuse Treatment Center, VA Medical Center
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18072840
Citation
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.
Results Reference
result
PubMed Identifier
17874878
Citation
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.
Results Reference
result

Learn more about this trial

Smoking Cessation in Alcoholism Treatment

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