Phase 2
N=97
A118G SNP and OPRM1 Gene Opioid-Mediated Effects in Humans
Opioid Sensitivity · Individual Difference · Abuse Opioids
Bottom Line
View on ClinicalTrials.gov: NCT02360371 ↗Enrolled (actual)
97
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcome: Primary: Self-report Visual Analog Ratings of HIGH — 7.2; 6.6; 4.5; 5.6 score on a scale — p=0.567
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Within-subject test of blinded study medication (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Self-report Visual Analog Ratings of HIGH |
7.2; 6.6; 4.5; 5.6; 12.5; 18.4 | 0.567 |
| PRIMARY Self-report Visual Analog Ratings of DRUG EFFECT |
13.3; 11.1; 10.8; 11.0; 23.6; 31.9 | 0.805 |
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.
Eligibility Criteria
Inclusion Criterion:
- 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 Criterion:
- 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.
- If female, not be pregnant or breastfeeding
- 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.
- BMI >30 (obese category)
Data sourced from ClinicalTrials.gov (NCT02360371). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.