Completed
Nalmefene in Nicotine and Alcohol Dependence
Led by The Scripps Research Institute · Updated on 2017-04-20
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
T
The Scripps Research Institute
Lead Sponsor
N
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meets criteria for alcohol dependence and nicotine dependence.
- Expresses a desire to cut down or stop drinking and smoking.
You will not qualify if you...
- 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.
Trial Site Locations
Total: 1 location
1
Department of Psychiatry, University of Miami School of Medicine
Miami, Florida, United States, 33136
Status Unknown
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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