NCT07668635

Brief Summary

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
61mo left

Started Jul 2026

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 25, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

July 30, 2026

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2030

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2031

Last Updated

June 25, 2026

Status Verified

June 1, 2026

Enrollment Period

4 years

First QC Date

June 19, 2026

Last Update Submit

June 19, 2026

Conditions

Opioid Use DisorderCannabis Use

Keywords

opioid usecannabis

Outcome Measures

Primary Outcomes (1)

  • Number of Opioid Self-Administration Trials Completed

    Number of drug-choice trials completed for intranasal opioid agonists during self-administration sessions.

    Up to 6.5 Weeks

Study Arms (2)

Active Cannabis

EXPERIMENTAL

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: CannabisDrug: Intranasal Opioid AgonistDrug: Oral Opioid Agonist

Placebo Cannabis

PLACEBO COMPARATOR

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: Placebo CannabisDrug: Intranasal Opioid AgonistDrug: Oral Opioid Agonist

Interventions

CannabisDRUG

Cannabis is administered three times daily during the active cannabis treatment period.

Active Cannabis
Placebo CannabisDRUG

Matched placebo cannabis is administered three times daily during the placebo treatment period.

Placebo Cannabis
Intranasal Opioid AgonistDRUG

Intranasal opioid agonists are administered during sample and self-administration sessions

Active CannabisPlacebo Cannabis
Oral Opioid AgonistDRUG

Oral opioid agonist maintenance doses are administered four times daily throughout study participation.

Active CannabisPlacebo Cannabis

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Individuals seeking treatment for opioid use disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky Center on Drug and Alcohol Research

Lexington, Kentucky, 40508, United States

Location

MeSH Terms

Conditions

Opioid-Related DisordersMarijuana Abuse

Interventions

nabiximolsAnalgesics, Opioid

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

NarcoticsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesAnalgesicsSensory System AgentsPeripheral Nervous System AgentsCentral Nervous System AgentsTherapeutic Uses

Study Officials

  • Shanna Babalonis, PhD

    University of Kentucky, College of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul Nuzzo

CONTACT

859-323-0002paul.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
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 19, 2026

First Posted

June 25, 2026

Study Start

July 30, 2026

Primary Completion (Estimated)

July 30, 2030

Study Completion (Estimated)

July 30, 2031

Last Updated

June 25, 2026

Record last verified: 2026-06

Locations

US(1)