Smoking Cessation in Alcoholism Treatment - Full Text View

Sponsor:	Yale University
Collaborator:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:	Yale University
ClinicalTrials.gov Identifier:	NCT00000454

Purpose

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	Intervention	Phase
Alcoholism Smoking	Drug: nicotine replacement patch	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Masking: Open Label Primary Purpose: Treatment
Official Title:	Field Study of Smoking Cessation in Alcoholism Treatment

Resource links provided by NLM:

MedlinePlus related topics: Alcoholism Quitting Smoking Smoking

Drug Information available for: Nicotine tartrate Nicotine polacrilex

U.S. FDA Resources

Further study details as provided by Yale University:

Estimated Enrollment:	112
Estimated Study Completion Date:	August 2002

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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)

More Information

Publications:

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.

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.

ClinicalTrials.gov Identifier:	NCT00000454 History of Changes
Other Study ID Numbers:	NIAAACOO11197, R01AA011197
Study First Received:	November 2, 1999
Last Updated:	May 18, 2010
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Alcoholism
Smoking
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Habits
Nicotine
Ganglionic Stimulants
Autonomic Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012