Opioid and Cannabinoid Interactions

March 24, 2025 updated by: Shanna Babalonis, PhD

Interactions of Marijuana and Opioids: Pharmacodynamic Effects

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

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, 40508
        • 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

No

Description

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 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: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vaporized Marijuana
Participants will receive non-therapeutic, experimental doses of active vaporized marijuana. Active marijuana will be administered once per session and will be administered via a vaporizer.
Drug: Vaporized Marijuana
Active Marijuana administered through vaporizer
Other Names:
  • THC
  • Cannabis
Drug: Placebo
Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)
Experimental: Opioid Agonist
Participants will receive non-therapeutic, experimental doses of an active opioid agonist. Active opioid agonist will be administered once per session and will be administered intranasally (snorting).
Drug: Placebo
Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)
Drug: Opioid Agonist
Active Opioid Agonist administered intranasally
Other Names:
  • Oxycodone
Experimental: Opioid Agonist/Marijuana Combination
Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana 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 administered through vaporizer
Other Names:
  • THC
  • Cannabis
Drug: Opioid Agonist
Active Opioid Agonist administered intranasally
Other Names:
  • Oxycodone
Placebo Comparator: Placebo
Participants will receive non-therapeutic, experimental doses of placebo. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer.
Drug: Placebo
Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Subject-Rated Outcome - VAS Drug Liking
Time Frame: This outcome (visual analog scores, scale of 0-100) was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a peak score was calculated across all these time intervals.
Participants rated their subjective drug liking on a standardized VAS scale (0 to 100). Low scores mean little to no drug liking. Higher scores mean greater drug liking. Raw data transformed to peak scores.
This outcome (visual analog scores, scale of 0-100) was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a peak score was calculated across all these time intervals.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Oxygen Saturation
Time Frame: Oxygen saturation was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a score was calculated across all these time intervals.
Oxygen saturation (measured as a percentage) monitored throughout each session. Raw data transformed to trough scores.
Oxygen saturation was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a score was calculated across all these time intervals.
Change in Respiration Rate
Time Frame: Respiration rate was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a score was calculated across all these time intervals.
Respiration rate (number of breaths per minute). Raw data transformed to trough scores.
Respiration rate was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a score was calculated across all these time intervals.
Change in Systolic Blood Pressure
Time Frame: Blood pressure was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a peak score was calculated across all these time intervals.
Systolic blood pressure (mm Hg). Raw data transformed to peak scores.
Blood pressure was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a peak score was calculated across all these time intervals.
Change in Diastolic Blood Pressure
Time Frame: Blood pressure was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a peak score was calculated across all these time intervals.
Diastolic blood pressure (mm Hg). Raw data transformed to peak scores.
Blood pressure was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a peak score was calculated across all these time intervals.

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)

June 21, 2019

Primary Completion (Actual)

February 15, 2024

Study Completion (Actual)

February 15, 2024

Study Registration Dates

First Submitted

October 3, 2018

First Submitted That Met QC Criteria

October 10, 2018

First Posted (Actual)

October 15, 2018

Study Record Updates

Last Update Posted (Actual)

April 10, 2025

Last Update Submitted That Met QC Criteria

March 24, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

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

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We have no plans to share individual participant data with other researchers.

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.

Clinical Trials on Opioid Use

Clinical Trials on Vaporized Marijuana

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United States

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe