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Phase 1 Completed N=11 Randomized Double-blind Basic Science

The Behavioral Effects of Opioids and Alcohol

Opioid Use Disorder · Alcohol Drinking
Source: ClinicalTrials.gov NCT04300751 ↗
Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcomePrimary: Peak Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Liking — 12.9; 47.1; 49.9; 54.8 score on a scale

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.

Outcome Measures

OutcomeResultp-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

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
View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.

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