Phase 1
Completed N=11
Prescription Medication Interactions
Opioid Use Disorder · Sedative Use
Source: ClinicalTrials.gov NCT04315181 ↗
Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcomePrimary: Change in Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Liking — 7.40; 39.00; 40.80; 24.50 Score on a scale — p=<0.0001
Summary
This study will examine the effects of doses of opioid/placebo and doses of sedative/placebo, alone and in combination. The primary outcomes are related to pharmacodynamic measures (subjective ratings of drug liking and other abuse-related effects; physiological outcomes) to determine the interaction effects of these compounds.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Liking |
7.40; 39.00; 40.80; 24.50; 15.00; 40.70 | <0.0001 sig |
| SECONDARY Change in Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Effect |
10.70; 39.30; 39.70; 25.00; 21.50; 39.10 | <0.0001 sig |
| SECONDARY Change in Respiration Rate |
12.70; 12.00; 11.50; 12.10; 12.90; 11.80 | 0.138 |
| SECONDARY Change in End-tidal Carbon Dioxide (EtCO2) |
39.60; 41.20; 42.90; 39.10; 38.40; 42.00 | <0.0001 sig |
| SECONDARY Change in Oxygen Saturation |
96.77; 96.29; 95.72; 96.86; 96.87; 96.59 | 0.0002 sig |
Eligibility Criteria
Inclusion Criteria
- Healthy adults, ages 18-55
- Current non-medical use of opioids and sedatives
Exclusion Criteria
- Physical dependence on opioids, alcohol, or benzodiazepines/sedatives/hypnotics
- Seeking treatment for drug use
- Significant medical problems
Data sourced from ClinicalTrials.gov (NCT04315181). 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. Informational only — not medical advice.