Cannabis Effects on Opioid Self-Administration

June 19, 2026 updated by: Shanna Babalonis, PhD

Impact of Cannabis on Opioid Self-Administration

The study will enroll participants with opioid use disorder and participants will reside at the University of Kentucky Hospital for this 6-week inpatient trial. During this time, double-blind doses of cannabis and opioids will be administered. The goal of the project is to determine if cannabis can alter the drive/desire to take opioids.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

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 Center on Drug and Alcohol Research

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 who experience opioid withdrawal
  • No allergies or adverse reactions to cannabis or opioids
  • Willing to stay inpatient at the UK Hospital research center for approx. 6 weeks

Exclusion Criteria:

  • Individuals seeking treatment for opioid use disorder

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: Active Cannabis
Participants receive active cannabis three times daily for approximately 16 days during one crossover treatment period. During this period, participants complete sample and self-administration sessions evaluating placebo and active intranasal opioid administration.
Drug: Cannabis
Cannabis is administered three times daily during the active cannabis treatment period.
Drug: Intranasal Opioid Agonist
Intranasal opioid agonists are administered during sample and self-administration sessions
Drug: Oral Opioid Agonist
Oral opioid agonist maintenance doses are administered four times daily throughout study participation.
Placebo Comparator: Placebo Cannabis
Participants receive placebo cannabis three times daily for approximately 16 days during one crossover treatment period. During this period, participants complete sample and self-administration sessions evaluating placebo and active intranasal opioid administration.
Drug: Intranasal Opioid Agonist
Intranasal opioid agonists are administered during sample and self-administration sessions
Drug: Oral Opioid Agonist
Oral opioid agonist maintenance doses are administered four times daily throughout study participation.
Drug: Placebo Cannabis
Matched placebo cannabis is administered three times daily during the placebo treatment period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Opioid Self-Administration Trials Completed
Time Frame: Up to 6.5 Weeks
Number of drug-choice trials completed for intranasal opioid agonists during self-administration sessions.
Up to 6.5 Weeks

Collaborators and Investigators

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

Sponsor

Shanna Babalonis, PhD

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, 2030

Study Completion (Estimated)

July 30, 2031

Study Registration Dates

First Submitted

June 19, 2026

First Submitted That Met QC Criteria

June 19, 2026

First Posted (Actual)

June 25, 2026

Study Record Updates

Last Update Posted (Actual)

June 25, 2026

Last Update Submitted That Met QC Criteria

June 19, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 106065

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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