Cannabis and Opioid Use Disorder

Phase 1

Recruiting

• Conditions: Opioid Use Disorder
• Interventions: Drug: Inhaled vaporized cannabis; Drug: Intransal opioid

• Registration Number: NCT05729932
• Lead Sponsor: University of Kentucky

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-13
• Study First Submitted QC: 2023-02-06
• Study First Posted: 2023-02-15
• Study Start: 2024-09-10
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-10
• Primary Completion: 2027-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Current opioid use disorder

Exclusion Criteria

• Current medical conditions that require medical management

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Vaporized cannabis	Inhaled 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.
Intranasal Opioid Agonist	Inhaled vaporized cannabis	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).
Intranasal Opioid Agonist	Intransal opioid	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).
Vaporized cannabis	Intransal opioid	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.

Primary Outcome Measures

Name	Time	Method
Change from Baseline - Opioid Withdrawal Severity - Visual Analog Scale (VAS)	Change from baseline	Subjective ratings of opioid withdrawal severity on visual analog scale (scale 0-100; 0 = not at all, 100 = extremely)

Secondary Outcome Measures

Name	Time	Method
Change from Baseline - Opioid Drug Liking - Visual Analog Scale (VAS)	Change from baseline	Subjective ratings of drug liking on visual analog scale (scale 0-100, 0 = not at all, 100 = extremely)
Change from Baseline - Respiration	Change from baseline	Physiological monitoring of respiration rate (breaths per minute)

Trial Locations

Locations (1)

Center on Drug and Alcohol Research; 🇺🇸 Lexington, Kentucky, United States