Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone)

This study has been completed.

First Received on November 2, 1999. Last Updated on July 21, 2010 History of Changes

Sponsor:	The Scripps Research Institute
Collaborator:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:	The Scripps Research Institute
ClinicalTrials.gov Identifier:	NCT00000437

Purpose

The purpose of this study is to determine the effectiveness of naltrexone (Revia) in reducing drinking and smoking in patients with both nicotine and alcohol dependence.

Individuals will be randomly assigned to a 12-week trial of a fixed daily dose of either naltrexone (Revia) and nicotine replacement patch or placebos. All individuals will receive weekly coping skills and smoking-cessation behavioral therapy. Followup interviews will be conducted 3 and 6 months after treatment to determine smoking and drinking status and persistence of any dependence symptoms.

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Nalmefene in Nicotine and Alcohol 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 The Scripps Research Institute:

Estimated Enrollment:	166
Study Completion Date:	December 2003

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Meets criteria for alcohol dependence and nicotine dependence.
Expresses a desire to cut down or stop drinking and smoking.

Exclusion Criteria:

Currently meets criteria for dependence on substances other than alcohol and nicotine.
Any history of opiate dependence or evidence of current opiate use.
Significant medical disorders that will increase potential risk or interfere with study participation.
Liver function tests more than 3 times normal or elevated bilirubin.
Females who are pregnant, nursing, or not using a reliable method of birth control.
Meets criteria for a major psychiatric disorder and is in need of or currently undergoing drug therapy.
Inability to understand and/or comply with the provisions of the protocol and consent form.
Treatment with an investigational drug during the previous month.
Chronic treatment with any narcotic-containing medications during the previous month.
Sensitivity to drug as evidenced by adverse drug experiences especially with narcotic- containing analgesics or opioid antagonists.
Current treatment with disulfiram (Antabuse) or nicotine replacement therapy.
More than 6 weeks of abstinence.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000437

Locations

United States, Florida
Department of Psychiatry, University of Miami School of Medicine
Miami, Florida, United States, 33136

Sponsors and Collaborators

The Scripps Research Institute

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

Principal Investigator:

Barbara Mason, PhD

University of Miam

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00000437 History of Changes
Other Study ID Numbers:	NIAAAMAS11210, R01AA011210
Study First Received:	November 2, 1999
Last Updated:	July 21, 2010
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Alcoholism
Smoking
Tobacco Use Disorder
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Habits
Naltrexone
Nicotine polacrilex
Nicotine
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Ganglionic Stimulants
Autonomic Agents
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants

ClinicalTrials.gov processed this record on February 12, 2012