The Behavioral Effects of Opioids and Alcohol

NCT04300751 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 55176R01DA016718
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Opioid Use; Alcohol Drinking

Keywords

opioid; opiate; alcohol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Peak Subject-Rated Outcome: Visual Analog Scale (VAS) - How Drunk do You Feel?

  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 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

  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).

Study Arms (3)

Alcohol

EXPERIMENTAL

Participants will receive experimental doses of active or placebo alcohol, p.o. Alcohol/placebo will be administered once per session.

Drug: Alcohol

Opioid Agonist

EXPERIMENTAL

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

Opioid Agonist/Alcohol Combination

EXPERIMENTAL

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: Alcohol; Drug: Opioid Agonist

Interventions

Alcohol DRUG

Active alcohol or placebo, administered orally

Alcohol; Opioid Agonist/Alcohol Combination

Opioid Agonist DRUG

Active opioid agonist or placebo, administered orally

Opioid Agonist; Opioid Agonist/Alcohol Combination

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adults ages 21-55
• Current non-medical use of opioids
• Previous alcohol use

You may not qualify if:

• Physical dependence on opioids, alcohol, or benzodiazepines/sedative/hypnotics
• Seeking treatment for drug use
• Significant medical problems

Sponsors & Collaborators

• Sharon Walsh: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40508, United States

Location

MeSH Terms

Conditions

Alcohol Drinking

Interventions

Ethanol; Analgesics, Opioid

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Results Point of Contact

• Title: Director for the Center on Drug and Alcohol Research
• Organization: University of Kentucky

Sharon.Walsh@uky.edu

859-257-6485

Study Officials

• Sharon L Walsh, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This is a randomized, double-blind, double-dummy, placebo-controlled, within-subjects design
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of the Center on Drug and Alcohol Research

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: March 9, 2020
• Study Start: March 24, 2021
• Primary Completion: November 9, 2024
• Study Completion: November 9, 2024
• Last Updated: November 20, 2025
• Results First Posted: November 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)