Status:
COMPLETED
Extended-Release vs. Oral Naltrexone Alcohol Treatment in Primary Care
Lead Sponsor:
NYU Langone Health
Conditions:
Alcohol Dependence
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The proposed study is a pragmatic, randomized, open-label clinical trial of 24 weeks of XR-NTX vs. O-NTX using a COMBINE-adapted Medical Management primary care treatment model. 237 adults \>18yo with...
Detailed Description
Rationale: Though integration of alcohol pharmacotherapy into primary care settings is receiving increasing emphasis and support, rigorous data to inform clinicians' treatment choice is lacking. The m...
Eligibility Criteria
Inclusion
- Adults, age ≥18 y.o.
- English- or Spanish- speaking and able to understand study procedures and provide full consent.
- DSM IV diagnosis of alcohol dependence as determined by study physician and DSM IV checklist.
- Endorses goal of abstinence, and is able to achieve alcohol abstinence without inpatient detoxification, per study physician.
Exclusion
- Current opioid dependence and/or positive urine toxicology for extended opioids.
- Pregnancy or female planning conception.
- Allergy to naltrexone or the PGL XR-NTX formulation or diluent.
- Severe liver disease, liver failure, or liver function test levels greater than three times normal.
- Other severe, untreated or uncontrolled medical illness (e.g., severe heart failure or dementia).
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 3 2018
Estimated Enrollment :
237 Patients enrolled
Trial Details
Trial ID
NCT01893827
Start Date
June 1 2014
End Date
October 3 2018
Last Update
June 16 2020
Active Locations (1)
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1
New York University School of Medicine
New York, New York, United States, 10016