A118G SNP and OPRM1 Gene Opioid-Mediated Effects in Humans

PHASE2CompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

April 30, 2015

Primary Completion Date

May 31, 2020

Study Completion Date

May 31, 2021

Conditions
Opioid SensitivityIndividual DifferenceAbuse Opioids
Interventions
DRUG

Within-subject test of blinded study medication

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.

Trial Locations (1)

21224

Johns Hopkins University Bayview Medical Campus, Baltimore

All Listed Sponsors
collaborator

National Institute on Drug Abuse (NIDA)

NIH

lead

Johns Hopkins University

OTHER

NCT02360371 - A118G SNP and OPRM1 Gene Opioid-Mediated Effects in Humans | Biotech Hunter | Biotech Hunter