Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone)

• Status: Completed
• Trial end date: 2005-09-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Scripps Research Institute
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Naltrexone; Nicotine

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.