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Not yet recruiting NCT07668635

Cannabis Effects on Opioid Self-Administration

Phase I Interventional Opioid Use Disorder 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: Cannabis, Placebo Cannabis, Intranasal Opioid Agonist, Oral Opioid Agonist.
Who it may be relevant to
Registry conditions: Opioid Use Disorder, 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 →

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Official title

Impact of Cannabis on Opioid Self-Administration

Overview

The study will enroll participants with opioid use disorder and participants will reside at the University of Kentucky Hospital for this 6-week inpatient trial. During this time, double-blind doses of cannabis and opioids will be administered. The goal of the project is to determine if cannabis can alter the drive/desire to take opioids.

Interventions

  • Drug Cannabis
    Cannabis is administered three times daily during the active cannabis treatment period.
  • Drug Placebo Cannabis
    Matched placebo cannabis is administered three times daily during the placebo treatment period.
  • Drug Intranasal Opioid Agonist
    Intranasal opioid agonists are administered during sample and self-administration sessions
  • Drug Oral Opioid Agonist
    Oral opioid agonist maintenance doses are administered four times daily throughout study participation.

Primary outcome measures

  • Number of Opioid Self-Administration Trials Completed [Time frame: Up to 6.5 Weeks]

Eligibility criteria

Inclusion criteria

  • Participants with moderate to severe opioid use disorder who experience opioid withdrawal
  • No allergies or adverse reactions to cannabis or opioids
  • Willing to stay inpatient at the UK Hospital research center for approx. 6 weeks

Exclusion criteria

  • Individuals seeking treatment for opioid use disorder

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 Center on Drug and Alcohol Research — Lexington

Identifiers

NCT: NCT07668635 · 106065

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗