Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone)

This study has been completed.

First Received: November 2, 1999 Last Updated: December 7, 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:	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:	Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
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 National Institute on Alcohol Abuse and Alcoholism (NIAAA):

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

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

Principal Investigator:

Barbara Mason, PhD

University of Miam

More Information

No publications provided

Study ID Numbers:	NIAAAMAS11210
Study First Received:	November 2, 1999
Last Updated:	December 7, 2007
ClinicalTrials.gov Identifier:	NCT00000437 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
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 27, 2009