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Not yet recruiting NCT07661446

Cannabis and Opioid Use Disorder, Study 2

Phase I Interventional Opioid Use Disorders Cannabis Use

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Inhaled Cannabis, Intranasal Opioid.
Who it may be relevant to
Registry conditions: Opioid Use Disorders, Cannabis Use. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

This inpatient study enrolls healthy individuals who have opioid use disorder. Participants live at the University of Kentucky Hospital for approx. 6 weeks. During this time, we will examine how repeated doses of oral cannabis and acute doses of oral and inhaled cannabis 1) modify the intensity and time course of opioid withdrawal, 2) modify the effects of intranasal opioid administration and 3) impact the safety of opioid administration.

Interventions

  • Drug Inhaled Cannabis
    Participants will receive inhaled cannabis and placebo
  • Drug Intranasal Opioid
    Participants will receive intranasal opioids and placebo

Primary outcome measures

  • Opioid withdrawal severity [Time frame: This outcome will be assessed regularly from baseline through 6 hours post cannabis dose during experimental sessions.]

Eligibility criteria

Inclusion criteria

  • Participants with moderate to severe opioid use disorder

Exclusion criteria

  • Individuals who do not use opioids or do not experience opioid withdrawal when they stop using opioids

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Triple blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • University of Kentucky — Lexington

Identifiers

NCT: NCT07661446 · 75562-20263

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗