Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone)
Completed · Phase 4 · Has a placebo group
Conditions studied: Alcoholism, Smoking
In brief
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.
Key facts
- Study ID
- NCT00000437
- Run by
- The Scripps Research Institute
- People needed
- 60
- Starts
- 1997-09-26
- Expected to finish
- 2005-09-15
- Last updated by the study team
- 2017-04-20
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Meets criteria for alcohol dependence and nicotine dependence.
- Expresses a desire to cut down or stop drinking and smoking.
You may not qualify if…
- 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.
Where it is running
- Department of Psychiatry, University of Miami School of Medicine — Miami, Florida, United States
Full record on ClinicalTrials.gov
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