A118G SNP and OPRM1 Gene Opioid-Mediated Effects in Humans

Phase 2

Completed

• Conditions: Opioid Sensitivity; Individual Difference; Abuse Opioids
• Interventions: Drug: Within-subject test of blinded study medication

• Registration Number: NCT02360371
• Lead Sponsor: Johns Hopkins University

Brief 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.

Detailed Description

Participants completed a 5-day, within-subject, double-blind, placebo-controlled, randomized, human laboratory abuse potential trial. Healthy individuals were admitted to a residential research unit for 5 consecutive days. Blood samples were drawn for genome wide analyses using the Global Screening Array on day 1. Participants were administered an oral dose of the opioid hydromorphone (4mg) on day 2 of the study. Persons who did not evidence strong agonist effects then proceeded into the randomized period wherein they received 0mg, 2mg, and 8mg of oral hydromorphone on the remaining three study days. The order of dosing was randomized, with only 1 dose administered per day and all participants receiving 1 exposure to each dose. Outcomes were standard human abuse potential metrics, including self-reported drug effects and feeling high. Data were analyzed as a function of the A118SNP on the OPRM1 gene that codes for the mu opioid receptor. The overall aim was to determine whether signal for abuse potential among persons with no history of opioid misuse was associated with genotype.

Study Timeline

• Study First Submitted: 2015-01-29
• Study First Submitted QC: 2015-02-05
• Study First Posted: 2015-02-10
• Study Start: 2015-04
• Primary Completion: 2020-05
• Study Completion: 2021-05
• Results First Submitted: 2021-07-20
• Results First Submitted QC: 2021-09-08
• Results First Posted: 2021-10-05
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo (oral)	Within-subject test of blinded study medication	Within-subject double-blind, administration of placebo oral capsule. Order of dose randomized session days 3-5.
Hydromorphone (oral) 2mg	Within-subject test of blinded study medication	Within-subject double-blind, administration of hydromorphone via oral capsule. Order of dose randomized session days 3-5.
Hydromorphone (oral) 4mg	Within-subject test of blinded study medication	Hydromorphone oral capsule administered in double-blind manner on Day 2 as first study drug administration. Hydromorphone 4mg dosing day was set for safety purposes and non-randomized.
Hydromorphone (oral) 8mg	Within-subject test of blinded study medication	Within-subject double-blind, administration of hydromorphone via oral capsule. Order of dose randomized session days 3-5.

Primary Outcome Measures

Name	Time	Method
Self-report Visual Analog Ratings of HIGH	30 minutes after study drug administration	Peak visual analog rating scale values of HIGH (rated on 0-100 scale with higher scores indicating higher feeling of being HIGH) collected at 30 minute intervals post-drug administration for 6 hours.
Self-report Visual Analog Ratings of DRUG EFFECT	30 minutes after study drug administration	Peak visual analog rating scale values of DRUG EFFECT (rated on 0-100 scale with higher scores indicating higher drug effect) collected at 30 minute intervals post-drug administration for 6 hours.

Trial Locations

Locations (1)

Johns Hopkins University Bayview Medical Campus; 🇺🇸 Baltimore, Maryland, United States