Status:
COMPLETED
Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone)
Lead Sponsor:
The Scripps Research Institute
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcoholism
Smoking
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 an...
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 cop...
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.
- Current treatment with disulfiram (Antabuse) or nicotine replacement therapy.
- More than 6 weeks of abstinence.
Key Trial Info
Start Date :
September 26 1997
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2005
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00000437
Start Date
September 26 1997
End Date
September 15 2005
Last Update
April 20 2017
Active Locations (1)
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1
Department of Psychiatry, University of Miami School of Medicine
Miami, Florida, United States, 33136