Completed
Nalmefene Maintenance Treatment of Alcoholism
Led by The Scripps Research Institute · Updated on 2017-04-20
159
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 long-term effectiveness of naltrexone treatment in alcohol-dependent patients who respond to short-term treatment. Those who respond to short-term treatment will be randomized to a 1-year, double-blind, placebo-controlled maintenance phase with a 6-month posttreatment followup.
CONDITIONS
Official Title
Naltrexone Maintenance Treatment of Alcoholism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meets criteria for alcohol dependence.
- Expresses a desire to cut down or stop drinking.
You will not qualify if you...
- Currently meets criteria for dependence on substances other than alcohol.
- 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.
- Female patients who are pregnant, nursing, or not using a reliable method of birth control.
- Inability to understand and provide a consent form.
- Treatment with an investigational drug during the previous month.
- Prior treatment with naltrexone.
- Chronic treatment with any narcotic-containing medications during the previous month.
- Sensitivity to naltrexone as evidenced by adverse drug experiences especially with narcotic containing analgesics or opioid antagonists.
- Current treatment with disulfiram.
- More than 6 weeks of abstinence.
- Meets criteria for a major psychiatric disorder and is in need of, or currently undergoing pharmacotherapy.
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
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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