At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 87 enrolled
Drug / intervention
Naltrexone +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Optimizing Naltrexone for Individuals of East Asian Descent
In Brief
A Phase 2 clinical trial evaluating Naltrexone and Placebo for Alcohol Use Disorder. Completed, enrolled 87 participants across 1 site.
Detailed Summary
This study will elucidate the pharmacogenetic effects of the Asn40Asp SNP of the OPRM1 gene on biobehavioral and neural markers of response to naltrexone in individuals of East Asian descent, an ethnic group most likely to express the positive predictive allele.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlcohol Use Disorder
CountriesUnited States
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartDec 2013
First PostedJan 2014
Primary CompletionSep 2016
TodayJul 2026
First PostedJan 1, 2014
Enrollment StartDec 1, 2013
Primary CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 12.5 years ago
Interventions
Naltrexonedrug
Naltrexone is an opioid receptor antagonist with highest affinity for mu opioid receptors
Placebodrug
Sugar pill, matched to the active study medication in capsule size and color