Status:
COMPLETED
Use of Naltrexone in a Clinical Setting
Lead Sponsor:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcoholism
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This 12-week trial will compare individuals receiving naltrexone or placebo plus substance abuse counseling therapy versus those receiving only substance abuse counseling therapy in a rural, nonacadem...
Eligibility Criteria
Inclusion Criteria:
- Meets criteria for alcohol dependence (within the past 3 months).
- Meets criteria for another substance use disorder (except narcotic dependence) but must identify alcohol as the primary substance of abuse.
- Must be able to provide an informed consent.
- Consent to random assignment and be willing to commit to possible medication treatment and research follow-up.
- Must be eligible for treatment at the Dorchester Alcohol and Drug Commission.
Exclusion Criteria:
- Meets criteria for opiate dependence.
- Clinically significant medical problems such as collagen-vascular disease, cardiovascular, renal, gastrointestinal or endocrine problem that would impair participation or limit medication ingestion.
- Hepatocellular disease.
- Women who are pregnant, nursing, or not practicing an effective means of birth control.
- Currently being prescribed naltrexone.
- Known sensitivity or allergy to naltrexone.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
September 1 2002
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00000445
End Date
September 1 2002
Last Update
June 24 2005
Active Locations (1)
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1
Center for Drug and Alcohol Programs, Medical University of South Carolina
Charleston, South Carolina, United States, 29425