Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone)

Phase 4

Completed

• Conditions: Smoking; Alcoholism
• Interventions: Drug: Naltrexone Tablet and Nicotine Patch; Drug: Naltrexone Tablet and Placebo Patch; Drug: Placebo Tablet and Nicotine Patch; Drug: Placebo Tablet and Placebo Patch

• Registration Number: NCT00000437
• Lead Sponsor: The Scripps Research Institute

Brief Summary

The purpose of this study is to determine the effectiveness of naltrexone (Revia) or matched placebo combined with nicotine patch (Nicotrol) or placebo patch using a 2x2 design in reducing drinking and smoking in patients with both nicotine and alcohol dependence.

Detailed Description

Eligible 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.

Study Timeline

• Study Start: 1997-09-26
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 1999-11-02
• Study First Posted: 1999-11-03
• Primary Completion: 2005-09-15
• Study Completion: 2005-09-15
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-18
• Last Update Posted: 2017-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Naltrexone Tablet and Nicotine Patch	Naltrexone Tablet and Nicotine Patch	-
Naltrexone Tablet and Placebo Patch	Naltrexone Tablet and Placebo Patch	-
Placebo Tablet and Nicotine Patch	Placebo Tablet and Nicotine Patch	-
Placebo Tablet and Placebo Patch	Placebo Tablet and Placebo Patch	-

Trial Locations

Locations (1)

Department of Psychiatry, University of Miami School of Medicine; 🇺🇸 Miami, Florida, United States