A118G SNP and OPRM1 Gene Opioid-Mediated Effects in Humans

Phase 2 Completed 100 enrolled Johns Hopkins University National Institute on Drug Abuse (NIDA) · collab

NaSingle-groupQuadruple-blindBasic science

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.

Timeline

Start: 2015-04
Primary completion: 2020-05
Completion: 2021-05

Outcome

Missed primary endpoint

registry analysis (superiority test); A118G (rs1799971-G) vs A118A (rs1799971-A); p = 0.567; Mixed methods NCT02360371 ↗

registry analysis (superiority test); A118G (rs1799971-G) vs A118A (rs1799971-A); p = 0.805; Mixed Model NCT02360371 ↗

Publications

Dunn KE, Huhn AS, Finan PH, Mange A, Bergeria CL, Maher BS, Rabinowitz JA, Strain EC, Antoine D. Polymorphisms in the A118G SNP of the OPRM1 gene produce different experiences of opioids: A human laboratory phenotype-genotype assessment. Addict Biol. 2024 Jan;29(1):e13355. doi: 10.1111/adb.13355.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Hydromorphone	Other / unclassified	2 mg	Oral
Subject	Hydromorphone	Other / unclassified	4 mg	Oral
Subject	Hydromorphone	Other / unclassified	8 mg	Oral