A118G SNP and OPRM1 Gene Opioid-Mediated Effects in Humans

• Status: Completed
• Trial end date: 2021-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: National Institute on Drug Abuse (NIDA)

Criteria

Inclusion Criterion:

1. Provide a urine sample that tests negative for opioids, methadone, buprenorphine, oxycodone, amphetamine, cocaine, and benzodiazepines

2. Negative ethanol breath test (0.000)

3. Aged 21-50

4. Deemed medically eligible to take hydromorphone

Exclusion Criterion:

1. Answer "yes" to question 1 of the Brief Pain Inventory (89) to assess the presence of chronic pain.

2. Current use of opioids or other medications for pain

3. Meet DSM-5 criteria for current or lifetime alcohol or drug use disorder (excluding nicotine)

4. Self-report any illicit drug use in the past 7 days

5. Self-report opioid use >5 days in the past 30

6. Evidence of opioid physical dependence at screening or following 1st residential overnight (following confirmed opioid abstinence)

7. Allergy to hydromorphone or other opioid agonists

8. Experience an adverse event that warrants opioid antagonist treatment following 1st hydromorphone dose.

9. If female, not be pregnant or breastfeeding

10. Presence of any clinically significant medical (e.g., chronic renal insufficiency, history of myocardial infarction, seizure disorder) and/or psychiatric illness (e.g., schizophrenia, bipolar disorder) that may interfere with study participation.

11. BMI >30 (obese category)