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

More Details

NCT ID
NCT04315181
Status
Completed
Sponsor
Sharon Walsh