A Phase 2 interventional study of Within-subject test of blinded study medication in Opioid Sensitivity, Individual Difference and Abuse Opioids, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-27.
Sponsored by Johns Hopkins University · Phase 2, Interventional, and Basic science
Within-subject, double-blind, placebo-controlled examination of opioid abuse potential in healthy individuals as a function of A118G SNP on the OPRM1 gene.
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.
1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.
This study's enrollment of 100 is above the median of 57 across 1,384 interventional studies indexed under Hypersensitivity.
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Exclusion Criterion:
Within-subject double-blind, administration of placebo oral capsule. Order of dose randomized session days 3-5.
Drug: 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.
Drug: 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.
Drug: 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.
Drug: Within-subject test of blinded study medication
Within-subject double-blind, randomized, placebo-controlled, residential human abuse potential study. All participants received 4mg oral hydromorphone on study day 2 and a subset continued into the randomized portion for study days 3-5 wherein they received placebo, 2mg hydromorphone, and 8mg hydromorphone in randomized order. Only one dose was administered per day and following randomized all participants received each dose in random order. Outcomes were collected during 8-hour residential-based sessions and included metrics of FDA human abuse potential testing as well as secondary outcomes of laboratory pain testing, subjective reports of drug effects, and cognitive performance, evaluated as a function of study medication condition. Participants were genotyped for rs-1799971 status and results were analyzed as between-group comparisons based upon genotype.
Self-report Visual Analog Ratings of HIGH
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.
Time frame: 30 minutes after study drug administration
Self-report Visual Analog Ratings of DRUG EFFECT
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.
Time frame: 30 minutes after study drug administration
100 participants were recruited from the community for participation. Analyses were based upon OPRM1 rs-1799971 allele status (A, G), which was available for 97 participants. All participants completed the same 4 study arms.
| Milestone | A118G (rs1799971-G) | A118A (rs1799971-A) |
|---|---|---|
| Started | 13 | 84 |
| Placebo (oral) | 13 | 69 |
| Hydromorphone (oral) 2mg | 13 | 69 |
| Hydromorphone (oral) 4mg | 13 | 69 |
| Hydromorphone (oral) 8mg | 13 | 69 |
| Completed | 13 | 69 |
| Not completed | 0 | 15 |
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.
| score on a scale | A118G (rs1799971-G) | A118A (rs1799971-A) |
|---|---|---|
| Placebo (oral) | 7.2 ± 13.2 | 6.6 ± 16.3 |
| Hydromorphone (oral) 2mg | 4.5 ± 5.9 | 5.6 ± 15.4 |
| Hydromorphone (oral) 4mg | 12.5 ± 19.8 | 18.4 ± 26.4 |
| Hydromorphone (oral) 8mg | 25.5 ± 29.7 | 22.5 ± 27.2 |
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.
| score on a scale | A118G (rs1799971-G) | A118A (rs1799971-A) |
|---|---|---|
| Placebo (oral) | 13.3 ± 21.3 | 11.1 ± 20.0 |
| Hydromorphone (oral) 2mg | 10.8 ± 16.5 | 11.0 ± 20.7 |
| Hydromorphone (oral) 4mg | 23.6 ± 27.0 | 31.9 ± 29.9 |
| Hydromorphone (oral) 8mg | 39.2 ± 37.3 | 39.5 ± 32.1 |
Collected over Adverse events collected for 6 hours post each drug administration session. Only adverse events (AEs) judged to be possibly, probably, or definitely related to study participation are reported.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo (Oral) | 0/82 (0%) | 0/82 (0%) | 19/82 (23.2%) |
| Hydromorphone (Oral) 2mg | 0/82 (0%) | 0/82 (0%) | 21/82 (25.6%) |
| Hydromorphone (Oral) 4mg | 0/97 (0%) | 0/97 (0%) | 65/97 (67%) |
| Hydromorphone (Oral) 8mg | 0/82 (0%) | 0/82 (0%) | 49/82 (59.8%) |
| Event | Placebo (Oral) | Hydromorphone (Oral) 2mg | Hydromorphone (Oral) 4mg | Hydromorphone (Oral) 8mg |
|---|---|---|---|---|
| DrowsinessNervous system disorders | 10/82 | 10/82 | 31/97 | 20/82 |
| NauseaGastrointestinal disorders | 3/82 | 5/82 | 29/97 | 18/82 |
| VomitingGastrointestinal disorders | 0/82 | 0/82 | 14/97 | 7/82 |
| DizzinessNervous system disorders | 0/82 | 0/82 | 8/97 | 9/82 |
| Light HeadednessNervous system disorders | 1/82 | 1/82 | 10/97 | 7/82 |
| HeadacheGeneral disorders | 5/82 | 8/82 | 6/97 | 6/82 |
| Pruritus (Itching)Nervous system disorders | 0/82 | 2/82 | 4/97 | 8/82 |
| LethargyNervous system disorders | 2/82 | 1/82 | 9/97 | 1/82 |
| SleepinessNervous system disorders | 1/82 | 2/82 | 8/97 | 4/82 |
| Dry Mouth (Xerostomia)General disorders | 1/82 | 0/82 | 5/97 | 6/82 |
| Age, Continuous(years) | A118G (rs1799971-G) | A118A (rs1799971-A) | Total |
|---|---|---|---|
| Mean | 37.6 ± 10.0 | 33.3 ± 8.9 | 33.9 ± 9.1 |
| Sex: Female, Male(Participants) | A118G (rs1799971-G) | A118A (rs1799971-A) | Total |
|---|---|---|---|
| Female | 4 | 45 | 49 |
| Male | 9 | 39 | 48 |
| Ethnicity (NIH/OMB)(Participants) | A118G (rs1799971-G) | A118A (rs1799971-A) | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 5 | 8 |
| Not Hispanic or Latino | 10 | 79 | 89 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | A118G (rs1799971-G) | A118A (rs1799971-A) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 1 | 4 | 5 |
| Native Hawaiian or Other Pacific Islander | 0 | 2 | 2 |
| Black or African American | 2 | 43 | 45 |
| White | 9 | 28 | 37 |
| More than one race | 0 | 5 | 5 |
| Unknown or Not Reported | 0 | 2 | 2 |
| Region of Enrollment(participants) | A118G (rs1799971-G) | A118A (rs1799971-A) | Total |
|---|---|---|---|
| United States | 13 | 84 | 97 |
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