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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.