Naltrexone for Medication Compliance Among HIV-infected Men With Alcohol Use Disorder
NCT ID: NCT01377168
Last Updated: 2017-06-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
159 participants
INTERVENTIONAL
2014-05-31
2017-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo pill
Daily oral placebo.
Placebo pill
NTX
Daily oral naltrexone.
oral naltrexone
Interventions
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oral naltrexone
Placebo pill
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 18 years and older
* Confirmed HIV infection, either through positive HIV antibody or detectable HIV-1 RNA level.
* No participation in pharmacotherapy trial in the previous 30 days
* Not pregnant
Exclusion Criteria
* Verbally or physically threatening to research staff
* Unable to communicate in Spanish
* Pending trials for a felony
* Childs-Pugh Class C Cirrhosis
* Grade 3 Hepatitis (LFTs \> 5X normal)
* Receiving opioid prescription narcotics or has pain syndrome necessitating future use of opioid prescription narcotics.
18 Years
MALE
No
Sponsors
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Yale University
OTHER
Asociación Civil Impacta Salud y Educación, Peru
OTHER
Fred Hutchinson Cancer Center
OTHER
Responsible Party
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Ann C Duerr
Member
Principal Investigators
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Ann Duerr, MD, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
Fred Hutchinson Cancer Center
Frederick Altice, MD
Role: STUDY_DIRECTOR
Yale University
Locations
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Asociación Civil Impacta Salud y Educación
Lima, , Peru
Countries
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Other Identifiers
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XR-NTX ETOH
Identifier Type: -
Identifier Source: org_study_id
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