The Behavioral Effects of Opioids and Alcohol

Interactions of Alcohol and Opioids: Pharmacodynamic Effects

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.

Study Overview

• Status: Completed
• Conditions: Alcohol Drinking; Opioid Use
• Intervention / Treatment: Drug: Opioid Agonist; Drug: Alcohol

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40508
      • University Of Kentucky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Alcohol; Participants will receive experimental doses of active or placebo alcohol, p.o. Alcohol/placebo will be administered once per session.	Drug: Alcohol; Active alcohol or placebo, administered orally
Experimental: Opioid Agonist; Participants will receive non-therapeutic, experimental doses of an active opioid agonist or placebo. Active opioid agonist/placebo will be administered once per session and will be administered orally	Drug: Opioid Agonist; Active opioid agonist or placebo, administered orally
Experimental: Opioid Agonist/Alcohol Combination; Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally.	Drug: Opioid Agonist; Active opioid agonist or placebo, administered orally; Drug: Alcohol; Active alcohol or placebo, administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Liking	Participants rated their subjective drug liking on a standardized VAS scale (0 to 100; 0=Not at all, 100=Extremely). A higher score indicates greater drug liking. This outcome was recorded multiple times at regular intervals throughout the experimental dose condition sessions. For each dose condition, the participants' peak value was pulled from the raw data and averaged to yield one mean (SEM).	These outcomes (visual analog scores, scale of 0-100) are recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Subject-Rated Outcome: Visual Analog Scale (VAS) - How Drunk do You Feel?	Participants rated their subjective response to the question "How drunk do you feel?" on a standardized VAS scale (0 to 100; 0=Not at all, 100=Extremely). A higher score indicates greater feeling of drunk. TThis outcome was recorded multiple times at regular intervals throughout the experimental dose condition sessions. For each dose condition, the participants' peak value was pulled from the raw data and averaged to yield one mean (SEM).	These outcomes (visual analog scores, scale of 0-100) are recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session)
Trough Oxygen Saturation	Oxygen saturation (measured as a percentage through pulse ox) monitored throughout each session. Lower scores indicate greater impairment. This outcome was recorded multiple times at regular intervals throughout the experimental dose condition sessions. For each dose condition, the participants' trough value was pulled from the raw data and averaged to yield one mean (SEM).	Oxygen Saturation recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session).
Peak Cold Pressor Test Threshold	Participants immerse their forearm in cold water (1.0 +/- .5 degree Celsius) and remove their arm from the cold water to indicated pain tolerance (max 5 mins). Cold Pressor Test Threshold (time elapsed since cold water immersion measured in seconds) monitored throughout each session. Higher scores indicate greater impairment. This outcome was recorded multiple times at regular intervals throughout the experimental dose condition sessions. For each dose condition, the participants' peak value was pulled from the raw data and averaged to yield one mean (SEM).	Cold Pressor Test Threshold was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session).

Collaborators and Investigators

• Sponsor: Sharon Walsh
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Sharon L Walsh, PhD, University Of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2021
• Primary Completion (Actual): November 9, 2024
• Study Completion (Actual): November 9, 2024

Study Registration Dates

• First Submitted: March 5, 2020
• First Submitted That Met QC Criteria: March 5, 2020
• First Posted (Actual): March 9, 2020

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 5, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: opioid; alcohol; opiate
• Additional Relevant MeSH Terms: Drinking Behavior; Behavior; Alcohol Drinking; Physiological Effects of Drugs; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics; Narcotics; Organic Chemicals; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Alcohols; Central Nervous System Agents; Analgesics, Opioid; Ethanol
• Other Study ID Numbers: 55176; R01DA016718 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We have no plans to share individual participant data with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No