Status:
COMPLETED
Extended-release Naltrexone for Alcohol Dependence in Primary Care
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
Alkermes, Inc.
Conditions:
Alcohol Dependence
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Naltrexone is an opioid antagonist with a high affinity for the mu opioid receptor. The efficacy of extended-release naltrexone (Vivitrol) as a treatment for alcohol dependence has been demonstrated i...
Eligibility Criteria
Inclusion
- Current alcohol dependence
- Age 18 or older
- English or Spanish-speaking
- Without untreated severe mental illness
- Liver enzymes (alanine aminotransferase and aspartate aminotransferase) ≤ 3x normal
- Kept 2 of last 3 clinic primary care appointments and/or has a working telephone number at which can be contacted directly
- Either a) currently abstinent (e.g., referred from an inpatient 'detox' setting) or b) with the ability, in the clinician's judgment, to achieve and maintain abstinence
- If female of child-bearing potential, must be using adequate contraception
- Able to understand study procedures
Exclusion
- Currently opioid dependent or requiring ongoing treatment with opioids for any indication
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00620750
Start Date
July 1 2007
End Date
February 1 2010
Last Update
September 27 2011
Active Locations (1)
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1
NYU School of Medicine
New York, New York, United States, 10016