Reinforcing Effects of Marijuana and Opioids

April 12, 2026 updated by: Shanna Babalonis, PhD

Modulation of Drug Intake: Evaluation of Opioid and Cannabinoid Interactions on Drug Self-Administration

The primary goals of this study are to examine 1) marijuana modulation of oxycodone self-administration and 2) oxycodone modulation of marijuana self-administration, under controlled conditions and across a range of doses for each drug.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40506
        • University Of Kentucky

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Ages 18-50
  • Experience with marijuana and opioids
  • General good health
  • Willing to live at the University of Kentucky Hospital (research unit) for approx. 6.5 weeks (meals are provided,

Exclusion Criteria:

  • Significant medical complications/conditions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Double-blind marijuana/placebo administration
Participants will receive double-blind administration of vaporized marijuana/placebo
Drug: Marijuana
Double-blind administration of marijuana
Other Names:
  • Cannabis
Drug: Opioid
Double-blind administration of an opioid agonist
Experimental: Double-blind opioid/placebo administration
Participants will receive double-blind administration of intranasal opioid agonist/placebo
Drug: Marijuana
Double-blind administration of marijuana
Other Names:
  • Cannabis
Drug: Opioid
Double-blind administration of an opioid agonist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-Administration of Drug Units Earned
Time Frame: Through a progressive-ratio self-administration model given once per treatment condition throughout each 6 hour session
The number of units of drug (out of a total of 7) earned in each experimental condition. Participants work for some, none, or all of the available drug dose. For each dose condition, the number of drug units completed for drug was pulled from the raw data and averaged to yield one mean (SEM).
Through a progressive-ratio self-administration model given once per treatment condition throughout each 6 hour session

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak End-tidal Carbon Dioxide (EtCO2)
Time Frame: This outcome was recorded prior to and in regular intervals after drug administration for the duration of each session (approximately 6 hours).
End-tidal Carbon Dioxide (EtCO2): For each dose condition, the participants' peak value was pulled from the raw data and averaged to yield one mean (SEM). Higher scores indicate greater impairment.
This outcome was recorded prior to and in regular intervals after drug administration for the duration of each session (approximately 6 hours).
Trough Respiration Rate
Time Frame: This outcome was recorded prior to and in regular intervals after drug administration for the duration of each session (approximately 6 hours).
Respiration rate (number of breaths per minute): For each dose condition, the participants' trough value was pulled from the raw data and averaged to yield one mean (SEM). Lower scores indicate greater impairment.
This outcome was recorded prior to and in regular intervals after drug administration for the duration of each session (approximately 6 hours).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanna Babalonis, PhD

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Shanna Babalonis, PhD, University Of Kentucky

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 3, 2023

Primary Completion (Actual)

March 27, 2025

Study Completion (Actual)

March 27, 2025

Study Registration Dates

First Submitted

July 18, 2022

First Submitted That Met QC Criteria

August 1, 2022

First Posted (Actual)

August 2, 2022

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 12, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 45017-20221
  • R01DA045700 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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