Alcohol and Opioids

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

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Stevie Britch, PhD; Phone Number: 8592574581; Email: Stevie.Britch@uky.edu
• Study Contact Backup: Name: Paul Nuzzo, MA; Phone Number: 8593230002; Email: Paul.nuzzo@uky.edu

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40508
      • Recruiting
      • University of Kentucky
      • Contact: Paul Nuzzo, MA; Phone Number: 859-323-0002; Email: Paul.nuzzo@uky.edu

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
Change in Subject-Rated Outcomes	Participants will rate their subjective drug effects (ex: drug liking, high) on standardized VAS scales.	These outcomes (visual analog scores, scale of 0-100) will be 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
Change in Oxygen Saturation	Oxygen saturation (measured as a percentage) will be monitored throughout each session	Oxygen saturation will be recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session)
Change in Respiration Rate	Respiration rate (number of breaths per minute)	Respiration rate will be recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session)
Change in Blood pressure	Systolic and diastolic blood pressure (mm Hg)	Blood pressure will be 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 Walsh, PhD, University of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2021
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): November 1, 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 30, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: opioid; alcohol; opiate
• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Analgesics, Opioid
• 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