Prescription Medication Interactions

Purpose

This study will examine the effects of doses of opioid/placebo and doses of sedative/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
  • Sedative Use

Eligibility

Eligible Ages
Between 18 Years and 55 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Healthy adults, ages 18-55
  • Current non-medical use of opioids and sedatives

Exclusion Criteria

  • Physical dependence on opioids, alcohol, or benzodiazepines/sedatives/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 design

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Oral opioid agonist
Participants will receive non-therapeutic experimental doses of active or placebo oral opioid agonist. 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
Oral sedative
Participants will receive non-therapeutic experimental doses of active or placebo oral sedative. Active sedative/placebo will be administered once per session and will be administered orally.
  • Drug: Sedatives
    Active sedative or placebo, administered orally
Experimental
Opioid agonist/sedative
Participants will receive non-therapeutic, experimental doses of active opioid agonist/placebo in combination with non-therapeutic, experimental doses of active sedative/placebo. Opioid/placebo and sedative/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid and sedative doses will be administered orally.
  • Drug: Opioid Agonist
    Active opioid agonist or placebo, administered orally
  • Drug: Sedatives
    Active sedative or placebo, administered orally

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

Center on Drug and Alcohol Research
Lexington, Kentucky 40208
Contact:
Paul A Nuzzo, M.A.
859-323-0002
pnuzz2@email.uky.edu

More Details

NCT ID
NCT04315181
Status
Recruiting
Sponsor
Sharon Walsh

Study Contact

Konnor QX Long, B.S.
859-257-4581
konnor@uky.edu