NCT00000437

Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone)

Nalmefene in Nicotine and Alcohol Dependence

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: The Scripps Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alcoholism
• Smoking

Interventions

Type	Name	Description
DRUG	Naltrexone Tablet and Nicotine Patch
DRUG	Naltrexone Tablet and Placebo Patch
DRUG	Placebo Tablet and Nicotine Patch
DRUG	Placebo Tablet and Placebo Patch

Timeline

• Start date: 1997-09-26
• Primary completion: 2005-09-15
• Completion: 2005-09-15
• First posted: 1999-11-03
• Last updated: 2017-04-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study