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NCT05729932 Clinical Trial

Cannabis and Opioid Use Disorder

Opioid Use Disorder Clinical Trial

Official title:
Cannabis Modulation of Outcomes Related to Opioid Use Disorder: Opioid Withdrawal, Abuse Potential and Safety

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05729932
Other study ID # 75562-20222
Secondary ID 1R01DA054347
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date June 2024
Est. completion date June 2027

Study information
Verified date February 2024
Source University of Kentucky
Contact Paul Nuzzo, MA
Phone 859-323-0002
Email pnuzz2@email.uky.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 15
Est. completion date June 2027
Est. primary completion date June 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - Current opioid use disorder Exclusion Criteria: - Current medical conditions that require medical management

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Inhaled vaporized cannabis
Double-blind cannabis and placebo doses, administered through vaporizer
• Intransal opioid
Double-blind opioid and placebo doses, administered intranasal route

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
University of Kentucky National Institute on Drug Abuse (NIDA)

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Change from Baseline - Opioid Drug Liking - Visual Analog Scale (VAS) Subjective ratings of drug liking on visual analog scale (scale 0-100, 0 = not at all, 100 = extremely) Change from baseline
Secondary Change from Baseline - Respiration Physiological monitoring of respiration rate (breaths per minute) Change from baseline
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