Opioid and Cannabinoid Interactions

February 27, 2024 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)

9

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 Contact

  • Name: Shanna Babalonis, Ph.D.
  • Phone Number: (859) 257-1881
  • Email: babalonis@uky.edu

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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Subject-Rated Outcomes
Time Frame: These outcomes (visual analog scores, scale of 0-100) will be recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).
Participants will rate their subjective drug effects (ex: drug liking, high) on standardized VAS scales.
These outcomes (visual analog scores, scale of 0-100) will be recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Oxygen Saturation
Time Frame: Oxygen saturation will be recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).
Oxygen saturation (measured as a percentage) will be monitored throughout each session.
Oxygen saturation will be recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).
Change in Respiration Rate
Time Frame: Respiration rate will be recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).
Respiration rate (number of breaths per minute)
Respiration rate will be recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).
Change in Blood pressure
Time Frame: Blood pressure will be recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).
Systolic and diastolic blood pressure (mm Hg)
Blood pressure will be recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).

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)

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 (Estimated)

February 29, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

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.

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