Behavioral/Drug Therapy for Alcohol-Nicotine Dependence (Naltrexone/Nicotine Patch)

This study has been completed.

First Received: November 2, 1999 Last Updated: December 6, 2007 History of Changes

Sponsor:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier:	NCT00000447

Purpose

This study will develop a behavioral and drug relapse prevention program for individuals who are dependent on both alcohol and tobacco. The study's goal is to show that individuals receiving nicotine replacement therapy and naltrexone (Revia) with behavior therapy will have higher rates of abstinence from both smoking and drinking than individuals who do not receive the drug therapies. Individuals will be placed in a 12-week outpatient treatment program with followup assessments 1, 3, and 6 months after treatment.

Condition	Intervention	Phase
Alcoholism Smoking	Drug: naltrexone (Revia) Drug: nicotine replacement patch	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study
Official Title:	Behavioral/Pharmacological Treatments for Alcohol-Nicotine Dependence

Resource links provided by NLM:

MedlinePlus related topics: Alcoholism Smoking

Drug Information available for: Nicotine tartrate Naltrexone Naltrexone hydrochloride Nicotine polacrilex

U.S. FDA Resources

Further study details as provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Estimated Enrollment:	200
Study Start Date:	September 1998
Study Completion Date:	May 2003

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Meets criteria for alcohol and nicotine dependence.
Individuals will be outpatients with alcohol and nicotine dependence who have completed detoxification (medicated or nonmedicated) within the past 48-120 hours.
Smoking no less than 10 cigarettes/day and no greater than 50 cigarettes/day.
Motivated to quit smoking.
Willing and able to participate in the 12 week outpatient treatment.
Acceptable health.
Able to provide a collateral informant.
Willing to be followed for 6 months after treatment ends.
Willing and able to provide the names of three family members or friends to aid in locating participants for follow-up.

Exclusion Criteria:

Current diagnosis of dependence on other substances except nicotine and alcohol.
Having moderately severe or severe alcohol withdrawal symptoms.
Recent (less than 48 hours) evidence of hazardous drinking (more than 2 drinks/day for females; 3 drinks/day for males).
History of opioid abuse.
Recent use of cocaine.
Not desiring to quit smoking.
Recent past or current pharmacotherapy involving naltrexone or transdermal nicotine systems.
History of psychosis.
Current suicidality, homicidally or psychiatric symptoms requiring other medications.
Presence of medical abnormalities that contraindicate naltrexone or nicotine replacement therapy.
Current treatment with psychotropic medications.
Pregnancy or nursing for female patients. Inability or unwillingness to participate in the 12-week outpatient treatment.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000447

Locations

United States, Texas
Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

Principal Investigator:

Joy Schmitz

The University of Texas Health Science Center, Houston

More Information

No publications provided

Study ID Numbers:	NIAAA-SCHMITZ-11216-04, NIH Grant 5R01AA011216-04
Study First Received:	November 2, 1999
Last Updated:	December 6, 2007
ClinicalTrials.gov Identifier:	NCT00000447 History of Changes
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Nicotine polacrilex
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Agonists
Nicotinic Agonists
Tobacco Use Disorder
Narcotic Antagonists
Physiological Effects of Drugs
Disorders of Environmental Origin
Central Nervous System Stimulants
Cholinergic Agents
Pharmacologic Actions

Autonomic Agents
Mental Disorders
Nicotine
Sensory System Agents
Therapeutic Uses
Alcoholism
Naltrexone
Ganglionic Stimulants
Substance-Related Disorders
Alcohol-Related Disorders
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 09, 2009