Alcohol and Opioids

Purpose

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

Eligibility

Eligible Ages
Between 21 Years and 55 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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 Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Basic Science
Masking
Double (Participant, Investigator)
Masking Description
This is a randomized, double-blind, double-dummy, placebo-controlled, within-subjects design

Arm Groups

ArmDescriptionAssigned Intervention
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: Alcohol
    Active alcohol or placebo, administered orally
  • Drug: Opioid Agonist
    Active opioid agonist or placebo, administered orally

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky
Lexington, Kentucky 40508
Contact:
Paul Nuzzo, MA
859-323-0002
Paul.nuzzo@uky.edu

More Details

NCT ID
NCT04300751
Status
Recruiting
Sponsor
Sharon Walsh

Study Contact

Stevie Britch, PhD
8592574581
Stevie.Britch@uky.edu