Cannabis and Opioid Use Disorder

December 10, 2025 updated by: Shanna Babalonis, PhD, University of Kentucky

Cannabis Modulation of Outcomes Related to Opioid Use Disorder: Opioid Withdrawal, Abuse Potential and Safety

This study plans to enroll participants with opioid use disorder who are not currently seeking treatment to assess the effects of cannabis on opioid withdrawal and other related outcomes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

15

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

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40508
        • Recruiting
        • Center on Drug and Alcohol Research
        • Contact:

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 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Current opioid use disorder

Exclusion Criteria:

  • Current medical conditions that require medical management

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intranasal Opioid Agonist
Participants will receive non-therapeutic, experimental doses of an opioid agonist or placebo. Active opioid agonist/placebo will be administered once per session and will be administered intransally (snorting).
Drug: Inhaled vaporized cannabis
Double-blind cannabis and placebo doses, administered through vaporizer
Drug: Intransal opioid
Double-blind opioid and placebo doses, administered intranasal route
Experimental: Vaporized cannabis
Participants will receive non-therapeutic, experimental doses of active or placebo vaporized cannabis. Active cannabis/placebo will be administered once per session and will be administered via a vaporizer.
Drug: Inhaled vaporized cannabis
Double-blind cannabis and placebo doses, administered through vaporizer
Drug: Intransal opioid
Double-blind opioid and placebo doses, administered intranasal route

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline - Opioid Withdrawal Severity - Visual Analog Scale (VAS)
Time Frame: Change from baseline
Subjective ratings of opioid withdrawal severity on visual analog scale (scale 0-100; 0 = not at all, 100 = extremely)
Change from baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline - Opioid Drug Liking - Visual Analog Scale (VAS)
Time Frame: Change from baseline
Subjective ratings of drug liking on visual analog scale (scale 0-100, 0 = not at all, 100 = extremely)
Change from baseline
Change from Baseline - Respiration
Time Frame: Change from baseline
Physiological monitoring of respiration rate (breaths per minute)
Change from baseline

Collaborators and Investigators

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

Sponsor

University of Kentucky

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)

September 10, 2024

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

January 13, 2023

First Submitted That Met QC Criteria

February 6, 2023

First Posted (Actual)

February 15, 2023

Study Record Updates

Last Update Posted (Estimated)

December 15, 2025

Last Update Submitted That Met QC Criteria

December 10, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 75562-20242
  • 1R01DA054347 (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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