Cannabis and Opioid Use Disorder

• Sponsor: University of Kentucky (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05729932
• Collaborator: (none)
• Enrollment: 15
• Arms: 2
• Anticipated Duration (Months): 41

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Opioid Use Disorder	Drug: Inhaled vaporized cannabis; Drug: Intransal opioid	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Basic Science
• Official Title: Cannabis Modulation of Outcomes Related to Opioid Use Disorder: Opioid Withdrawal, Abuse Potential and Safety
• Anticipated Study Start Date: Apr 1, 2023
• Anticipated Primary Completion Date: Aug 1, 2026
• Anticipated Study Completion Date: Sep 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intranasal Opioid Agonist 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 cannabis; Double-blind cannabis and placebo doses, administered through vaporizer; Drug: Intransal opioid; Double-blind opioid and placebo doses, administered intranasal route
Experimental: Vaporized cannabis 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 cannabis; Double-blind cannabis and placebo doses, administered through vaporizer; Drug: Intransal opioid; Double-blind opioid and placebo doses, administered intranasal route

Outcome Measures

Primary Outcome Measures

1. Change from Baseline - Opioid Withdrawal Severity - Visual Analog Scale (VAS) [Change from baseline]

   Subjective ratings of opioid withdrawal severity on VAS

Secondary Outcome Measures

1. Change from Baseline - Opioid Drug Liking - Visual Analog Scale (VAS) [Change from baseline]

   Subjective ratings of drug liking on VAS

2. Change from Baseline - Respiration [Change from baseline]

   Physiological monitoring of respiration rate

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Current opioid use disorder

Exclusion Criteria:

• Current medical conditions that require medical management

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Kentucky

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shanna Babalonis, PhD, Principal Investigator, University of Kentucky
• ClinicalTrials.gov Identifier: NCT05729932
• Other Study ID Numbers: 75562
• First Posted: Feb 15, 2023
• Last Update Posted: Feb 15, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Opioid-Related Disorders; Substance-Related Disorders; Analgesics, Opioid

Study Results

No Results Posted as of Feb 15, 2023