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

Tracking Information

First Received Date ^ICMJE

November 2, 1999

Last Updated Date

December 7, 2007

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00000437 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone)

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment

Condition ^ICMJE

Alcoholism
Smoking

Intervention ^ICMJE

Drug: naltrexone (Revia)
Drug: nicotine replacement patch

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

166

Completion Date

December 2003

Primary Completion Date

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00000437

Responsible Party

Study ID Numbers ^ICMJE

NIAAAMAS11210

Study Sponsor ^ICMJE

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Barbara Mason, PhD

University of Miam

Information Provided By

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP