Nalmefene in Nicotine and Alcohol Dependence
Overview
- Phase
- Phase 4
- Intervention
- Naltrexone Tablet and Nicotine Patch
- Conditions
- Alcoholism
- Sponsor
- The Scripps Research Institute
- Enrollment
- 60
- Locations
- 1
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Barbara J. Mason
Principal Investigator
The Scripps Research Institute
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.
Arms & Interventions
Naltrexone Tablet and Nicotine Patch
Intervention: Naltrexone Tablet and Nicotine Patch
Naltrexone Tablet and Placebo Patch
Intervention: Naltrexone Tablet and Placebo Patch
Placebo Tablet and Nicotine Patch
Intervention: Placebo Tablet and Nicotine Patch
Placebo Tablet and Placebo Patch
Intervention: Placebo Tablet and Placebo Patch
Outcomes
Primary Outcomes
Not specified