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Recruiting

NCT Number: NCT05729932

Cannabis and Opioid Use Disorder

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.

Recruiting

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Key information

Conditions

Opioid Use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Center on Drug and Alcohol Research

Lexington, Kentucky, 40508, United States

Location status: Recruiting

Location contact

Paul Nuzzo, MA

CONTACT

[email protected]

859-323-0002

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Current opioid use disorder

Exclusion criteria

  • Current medical conditions that require medical management

Treatment and study plan

Inhaled vaporized cannabis

Drug

Double-blind cannabis and placebo doses, administered through vaporizer

Intransal opioid

Drug

Double-blind opioid and placebo doses, administered intranasal route

Primary outcomes

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

    Time frame: Change from baseline

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

Secondary outcomes

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

    Time frame: Change from baseline

    Subjective ratings of drug liking on visual analog scale (scale 0-100, 0 = not at all, 100 = extremely)

  2. Change from Baseline - Respiration

    Time frame: Change from baseline

    Physiological monitoring of respiration rate (breaths per minute)

Study contacts

Contact information is provided by the study sponsor or research team.

Paul Nuzzo, MA

CONTACT

[email protected]

859-323-0002

Sponsors and collaborators

Lead sponsor

Shanna Babalonis, PhD

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 15, 2023
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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