Phase 1
N=11
The Behavioral Effects of Opioids and Alcohol
Opioid Use · Alcohol Drinking
Bottom Line
View on ClinicalTrials.gov: NCT04300751 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: Peak Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Liking — 12.9; 47.1; 49.9; 54.8 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Alcohol (Drug); Opioid Agonist (Drug)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- Sharon Walsh
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peak Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Liking |
12.9; 47.1; 49.9; 54.8; 61.2; 54.6 | — |
| SECONDARY Peak Subject-Rated Outcome: Visual Analog Scale (VAS) - How Drunk do You Feel? |
6.1; 6.5; 8.6; 41.2; 54; 39.6 | — |
| SECONDARY Trough Oxygen Saturation |
97.4; 96.8; 96.6; 96.6; 96.2; 96.1 | — |
| SECONDARY Peak Cold Pressor Test Threshold |
22.6; 63.3; 74.2; 43.4; 60.6; 54.1 | — |
Summary
This study will examine the effects of doses of alcohol/placebo and doses of opioid/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.
Eligibility Criteria
Inclusion Criteria
- Healthy adults ages 21-55
- Current non-medical use of opioids
- Previous alcohol use
Exclusion Criteria
- Physical dependence on opioids, alcohol, or benzodiazepines/sedative/hypnotics
- Seeking treatment for drug use
- Significant medical problems
Data sourced from ClinicalTrials.gov (NCT04300751). 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.