CompletedPhase 2

A118G SNP and OPRM1 Gene Opioid-Mediated Effects in Humans

United States100 participantsStarted 2015-04

Plain-language 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.

Who can participate

Age range21 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Provide a urine sample that tests negative for opioids, methadone, buprenorphine, oxycodone, amphetamine, cocaine, and benzodiazepines
✓. Negative ethanol breath test (0.000)
✓. Aged 21-50
✓. Deemed medically eligible to take hydromorphone

Exclusion criteria

✕. Answer "yes" to question 1 of the Brief Pain Inventory (89) to assess the presence of chronic pain.
✕. Current use of opioids or other medications for pain
✕. Meet DSM-5 criteria for current or lifetime alcohol or drug use disorder (excluding nicotine)
✕. Self-report any illicit drug use in the past 7 days
✕. Self-report opioid use \>5 days in the past 30
✕. Evidence of opioid physical dependence at screening or following 1st residential overnight (following confirmed opioid abstinence)
✕. Allergy to hydromorphone or other opioid agonists
✕. Experience an adverse event that warrants opioid antagonist treatment following 1st hydromorphone dose.

What they're measuring

Self-report Visual Analog Ratings of HIGH

Timeframe: 30 minutes after study drug administration

Self-report Visual Analog Ratings of DRUG EFFECT

Timeframe: 30 minutes after study drug administration

Trial details

NCT IDNCT02360371

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-05

Results submitted2021-07-20

View on ClinicalTrials.gov More Opioid Sensitivity trials