100
Participants
Start Date
April 30, 2015
Primary Completion Date
May 31, 2020
Study Completion Date
May 31, 2021
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.
Johns Hopkins University Bayview Medical Campus, Baltimore
National Institute on Drug Abuse (NIDA)
NIH
Johns Hopkins University
OTHER