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Smoking Cessation in Alcoholism Treatment

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ClinicalTrials.gov Identifier: NCT00000454
Recruitment Status : Completed
First Posted : November 3, 1999
Last Update Posted : May 19, 2010
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:
Yale University

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.

Condition or disease Intervention/treatment Phase
Alcoholism Smoking Drug: nicotine replacement patch Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 112 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Field Study of Smoking Cessation in Alcoholism Treatment
Study Completion Date : August 2002

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000454


Locations
United States, Connecticut
Substance Abuse Treatment Center, VA Medical Center
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Yale University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Publications of Results:
ClinicalTrials.gov Identifier: NCT00000454     History of Changes
Other Study ID Numbers: NIAAACOO11197
R01AA011197 ( U.S. NIH Grant/Contract )
First Posted: November 3, 1999    Key Record Dates
Last Update Posted: May 19, 2010
Last Verified: May 2010

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action