Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone) - Tabular View

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Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone)

This study has been completed.

Study NCT00000437. Last updated on December 7, 2007. Information provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone)

Official Title ^†

Nalmefene in Nicotine and Alcohol Dependence

Brief Summary

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.

Detailed Description

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

Alcoholism
Smoking

Intervention ^†

Drug: naltrexone (Revia)
Drug: nicotine replacement patch

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

166

Start Date ^†

Completion Date

December 2003

Eligibility 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.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00000437

Organization ID

NIAAAMAS11210

Secondary IDs ^††

Study Sponsor ^†

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborators ^††

Investigators ^†

Principal Investigator:

Barbara Mason, PhD

University of Miam

Information Provided By

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Verification Date

December 2007

First Received Date ^†

November 2, 1999

Last Updated Date

December 7, 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.