Cannabis and Opioid Use Disorder, Study 2

June 22, 2026 updated by: Shanna Babalonis, PhD, University of Kentucky
This inpatient study enrolls healthy individuals who have opioid use disorder. Participants live at the University of Kentucky Hospital for approx. 6 weeks. During this time, we will examine how repeated doses of oral cannabis and acute doses of oral and inhaled cannabis 1) modify the intensity and time course of opioid withdrawal, 2) modify the effects of intranasal opioid administration and 3) impact the safety of opioid administration.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants with moderate to severe opioid use disorder

Exclusion Criteria:

  • Individuals who do not use opioids or do not experience opioid withdrawal when they stop using opioids

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
Placebo Comparator: Oral cannabis (placebo)
Participants will receive placebo oral cannnabis
Drug: Inhaled Cannabis
Participants will receive inhaled cannabis and placebo
Drug: Intranasal Opioid
Participants will receive intranasal opioids and placebo
Experimental: Oral cannabis (active)
Participants will receive active oral cannabis
Drug: Inhaled Cannabis
Participants will receive inhaled cannabis and placebo
Drug: Intranasal Opioid
Participants will receive intranasal opioids and placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid withdrawal severity
Time Frame: This outcome will be assessed regularly from baseline through 6 hours post cannabis dose during experimental sessions.
Opioid severity is a participant-rated outcome that will be measured on a visual analog scale (0-100)
This outcome will be assessed regularly from baseline through 6 hours post cannabis dose during experimental sessions.

Collaborators and Investigators

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

Sponsor

University of Kentucky

Investigators

  • Principal Investigator: Shanna Babalonis, PhD, University of Kentucky College of Medicine

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 (Estimated)

July 30, 2026

Primary Completion (Estimated)

July 30, 2029

Study Completion (Estimated)

January 30, 2030

Study Registration Dates

First Submitted

June 16, 2026

First Submitted That Met QC Criteria

June 16, 2026

First Posted (Actual)

June 22, 2026

Study Record Updates

Last Update Posted (Actual)

June 26, 2026

Last Update Submitted That Met QC Criteria

June 22, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 75562-20263

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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