Cannabis and Opioid Use Disorder, Study 2

NCT07661446 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: 75562-20263
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Opioid Use Disorders; Cannabis Use

Keywords

Cannabis; marijuana; opioid; opioid use disorder; opioid withdrawal; opioid interaction

Outcome Measures

Primary Outcomes (1)

• Opioid withdrawal severity

  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.

Study Arms (2)

Oral cannabis (placebo)

PLACEBO COMPARATOR

Participants will receive placebo oral cannnabis

Drug: Inhaled Cannabis; Drug: Intranasal Opioid

Oral cannabis (active)

EXPERIMENTAL

Participants will receive active oral cannabis

Drug: Inhaled Cannabis; Drug: Intranasal Opioid

Interventions

Inhaled Cannabis DRUG

Participants will receive inhaled cannabis and placebo

Oral cannabis (active); Oral cannabis (placebo)

Intranasal Opioid DRUG

Participants will receive intranasal opioids and placebo

Oral cannabis (active); Oral cannabis (placebo)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participants with moderate to severe opioid use disorder

You may not qualify if:

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

Sponsors & Collaborators

• University of Kentucky: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40508, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Marijuana Abuse

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Shanna Babalonis, PhD

  University of Kentucky College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul Nuzzo

CONTACT

859-323-0002; paul.nuzzo@uky.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 22, 2026
• Study Start: July 30, 2026
• Primary Completion (Estimated): July 30, 2029
• Study Completion (Estimated): January 30, 2030
• Last Updated: June 26, 2026

Record last verified: 2026-06

Locations

US (1)