CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 100 enrolled
Drug / intervention
Within-subject test of blinded study medicationdrug
Likely dose
Within-subject test of blinded study medication 4mgfrom 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.

Search/NCT02360371
NCT02360371Phase 2Completed
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A118G SNP and OPRM1 Gene Opioid-Mediated Effects in Humans

Johns Hopkins University·interventional·Posted Feb 10, 2015·Updated Feb 27, 2025

In Brief

A Phase 2 clinical trial evaluating Within-subject test of blinded study medication for Opioid Sensitivity and 2 related conditions. Completed, enrolled 100 participants across 1 site.

Detailed Summary

Within-subject, double-blind, placebo-controlled examination of opioid abuse potential in healthy individuals as a function of A118G SNP on the OPRM1 gene.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid Sensitivity, Individual Difference, Abuse Opioids
CountriesUnited States
CollaboratorsNational Institute on Drug Abuse (NIDA)

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 10, 2015
Enrollment StartApr 1, 2015
Primary CompletionMay 1, 2020
Study CompletionMay 1, 2021
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 11.4 years ago

Interventions

Within-subject test of blinded study medicationdrug

Within-subject double-blind, randomized, placebo-controlled, residential human abuse potential study. All participants received 4mg oral hydromorphone on study day 2 and a subset continued into the randomized portion for study days 3-5 wherein they received placebo, 2mg hydromorphone, and 8mg hydromorphone in randomized order. Only one dose was administered per day and following randomized all participants received each dose in random order. Outcomes were collected during 8-hour residential-based sessions and included metrics of FDA human abuse potential testing as well as secondary outcomes of laboratory pain testing, subjective reports of drug effects, and cognitive performance, evaluated as a function of study medication condition. Participants were genotyped for rs-1799971 status and results were analyzed as between-group comparisons based upon genotype.