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Purpose

This study will examine the effects of doses of marijuana/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 18 Years and 50 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Healthy adults ages 18-50
  • Current non-medical use of opioids and marijuana

Exclusion Criteria

  • Physical dependence on opioids, alcohol benzodiazepines/sedative/hypnotics
  • Seeking treatment for drug use
  • Significant medical problems

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential 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
Vaporized Marijuana 		Participants will receive non-therapeutic, experimental doses of active or placebo. vaporized marijuana. Active marijuana/placebo will be administered once per session and will be administered via a vaporizer.
  • Drug: Vaporized Marijuana
    Active Marijuana or Placebo, administered through vaporizer
    Other names:
    • Cannabis
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 intranasally (snorting).
  • Drug: Opioid Agonist
    Active Opioid Agonist or Placebo, administered intranasally
Experimental
Opioid Agonist/Marijuana Combination 		Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with non-therapeutic, experimental doses of active vaporized marijuana/placebo. Opioid/placebo and marijuana/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer.
  • Drug: Vaporized Marijuana
    Active Marijuana or Placebo, administered through vaporizer
    Other names:
    • Cannabis
  • Drug: Opioid Agonist
    Active Opioid Agonist or Placebo, administered intranasally

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

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

More Details

NCT ID
NCT03705559
Status
Recruiting
Sponsor
Shanna Babalonis, PhD

Study Contact

Shanna Babalonis, Ph.D.
(859) 257-1881
babalonis@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.