Trial Outcomes & Findings for A Study to Evaluate the Abuse Potential of Oxymorphone Compared to Other Mu Opioid Agonists. (NCT NCT03389750)
NCT ID: NCT03389750
Last Updated: 2023-09-07
Results Overview
The positive subjective effects of the most efficacious dose of the intravenous challenge drugs. These are measured using self-reported assessment by the participant in terms of drug "liking" rated on a visual analog scale of 0-100. Higher values indicate a greater drug effect.
COMPLETED
PHASE2
16 participants
Throughout study enrollment period (8-9 weeks)
2023-09-07
Participant Flow
This investigation was a within-subjects design. The participants were presented with the following drugs/doses in randomized order: Oxymorphone (1.8, 3.2, 5.6, and 10 mg/70 kg) Oxycodone (10, 18, 32, 56 mg/70 kg) Hydromorphone (3.2, 5.6, 10, and 18 mg/70 kg) Placebo (0 mg). Data are only presented for individuals who received all 13 dose conditions (i.e., N=8).
Participant milestones
| Measure |
Intravenous Challenge Drug
Oxycodone, oxymorphone, hydromorphone and placebo were administered in random order. A morphine condition was dropped prior to the initiation of the trial.
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
Oxycodone
|
8
|
|
Overall Study
Oxymorphone
|
8
|
|
Overall Study
Hydromorphone
|
8
|
|
Overall Study
Placebo
|
8
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Abuse Potential of Oxymorphone Compared to Other Mu Opioid Agonists.
Baseline characteristics by cohort
| Measure |
Intravenous Challenge Drug
n=16 Participants
All participants received: oxycodone, oxymorphone, and hydromorphone for the purpose of comparison of their abuse potential among each other and to placebo (saline).
|
|---|---|
|
Age, Continuous
|
38 Years
STANDARD_DEVIATION 7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Throughout study enrollment period (8-9 weeks)Population: The most robust self-reported drug "Liking" across the various dose of each IV drug (Scale: 0-100). These data are reported only for study completers (i.e., those individuals who experienced all 13 drug \& dose drug conditions). Higher values indicate a greater drug effect.
The positive subjective effects of the most efficacious dose of the intravenous challenge drugs. These are measured using self-reported assessment by the participant in terms of drug "liking" rated on a visual analog scale of 0-100. Higher values indicate a greater drug effect.
Outcome measures
| Measure |
IV Placebo
n=8 Participants
Intravenous administration of placebo (saline, 0 mg/70kg)
|
IV Oxymorphone 1.8 mg
n=8 Participants
Intravenous administration of Oxymorphone 1.8 mg/70kg.
|
IV Oxymorphone 3.2 mg
n=8 Participants
Intravenous administration of Oxymorphone 3.2 mg/70kg.
|
IV Oxymorphone 5.6 mg
n=8 Participants
Intravenous administration of Oxymorphone 5.6 mg/70kg.
|
IV Oxymorphone 10 mg
n=8 Participants
Intravenous administration of Oxymorphone 10 mg/70kg.
|
IV Hydromorphone 3.2 mg
n=8 Participants
Intravenous administration of Hydromorphone 3.2 mg/70kg.
|
IV Hydromorphone 5.6 mg
n=8 Participants
Intravenous administration of Hydromorphone 5.6 mg/70kg.
|
IV Hydromorphone 10 mg
n=8 Participants
Intravenous administration of Hydromorphone 10 mg/70kg.
|
IV Hydromorphone 18 mg
n=8 Participants
Intravenous administration of Hydromorphone 18 mg/70kg.
|
IV Oxycodone 10 mg
n=8 Participants
Intravenous administration of Oxycodone 10 mg/70kg.
|
IV Oxycodone 18 mg
n=8 Participants
Intravenous administration of Oxycodone 18 mg/70kg.
|
IV Oxycodone 32 mg
n=8 Participants
Intravenous administration of Oxycodone 32 mg/70kg.
|
IV Oxycodone 56 mg
n=8 Participants
Intravenous administration of Oxycodone 56 mg/70kg.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Positive Subjective Drug Effects (i.e., Drug "Liking").
|
52.1 units on a scale
Standard Error 1.0
|
57.5 units on a scale
Standard Error 2.8
|
71.8 units on a scale
Standard Error 5.2
|
71.5 units on a scale
Standard Error 6.1
|
84 units on a scale
Standard Error 4.9
|
66.3 units on a scale
Standard Error 3.8
|
71.3 units on a scale
Standard Error 4.9
|
84.3 units on a scale
Standard Error 4.8
|
79.6 units on a scale
Standard Error 5.4
|
59.5 units on a scale
Standard Error 3.9
|
63.3 units on a scale
Standard Error 3.9
|
70.3 units on a scale
Standard Error 4.4
|
79.1 units on a scale
Standard Error 5.5
|
Adverse Events
IV Challenge Drug: Placebo 0 mg
IV Challenge Drug: Oxymorphone 1.8 mg
IV Challenge Drug: Oxymorphone 3.2 mg
IV Challenge Drug: Oxymorphone 5.6 mg
IV Challenge Drug: Oxymorphone 10 mg
IV Challenge Drug: Hydromorphone 3.2 mg
IV Challenge Drug: Hydromorphone 5.6 mg
IV Challenge Drug: Hydromorphone 10 mg
IV Challenge Drug: Hydromorphone 18 mg
IV Challenge Drug: Oxycodone 10 mg
IV Challenge Drug: Oxycodone 18 mg
IV Challenge Drug: Oxycodone 32 mg
IV Challenge Drug: Oxycodone 56 mg
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place