NCT05729932

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
13mo left

Started Sep 2024

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
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

Study Progress63%
Sep 2024Jun 2027

First Submitted

Initial submission to the registry

January 13, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 15, 2023

Completed
1.6 years until next milestone

Study Start

First participant enrolled

September 10, 2024

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

December 15, 2025

Status Verified

December 1, 2025

Enrollment Period

2.8 years

First QC Date

January 13, 2023

Last Update Submit

December 10, 2025

Conditions

Opioid Use Disorder

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline - Opioid Withdrawal Severity - Visual Analog Scale (VAS)

    Subjective ratings of opioid withdrawal severity on visual analog scale (scale 0-100; 0 = not at all, 100 = extremely)

    Change from baseline

Secondary Outcomes (2)

  • Change from Baseline - Opioid Drug Liking - Visual Analog Scale (VAS)

    Change from baseline

  • Change from Baseline - Respiration

    Change from baseline

Study Arms (2)

Intranasal Opioid Agonist

EXPERIMENTAL

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 cannabisDrug: Intransal opioid

Vaporized cannabis

EXPERIMENTAL

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 cannabisDrug: Intransal opioid

Interventions

Inhaled vaporized cannabisDRUG

Double-blind cannabis and placebo doses, administered through vaporizer

Intranasal Opioid AgonistVaporized cannabis
Intransal opioidDRUG

Double-blind opioid and placebo doses, administered intranasal route

Intranasal Opioid AgonistVaporized cannabis

Eligibility Criteria

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

You may qualify if:

  • Current opioid use disorder

You may not qualify if:

  • Current medical conditions that require medical management

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center on Drug and Alcohol Research

Lexington, Kentucky, 40508, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Shanna Babalonis, PhD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul Nuzzo, MA

CONTACT

859-323-0002pnuzz2@email.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
Principal Investigator

Study Record Dates

First Submitted

January 13, 2023

First Posted

February 15, 2023

Study Start

September 10, 2024

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

December 15, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)