Cannabis and Opioid Use Disorder, Study 2

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorUniversity of Kentucky

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants with moderate to severe opioid use disorder

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Inhaled Cannabis

    Drug

    Participants will receive inhaled cannabis and placebo

  • Intranasal Opioid

    Drug

    Participants will receive intranasal opioids and placebo

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Oral cannabis (placebo)Placebo comparator 2 interventions
Group B: Oral cannabis (active)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Opioid withdrawal severity

Opioid severity is a participant-rated outcome that will be measured on a visual analog scale (0-100)

Time frame
This outcome will be assessed regularly from baseline through 6 hours post cannabis dose during experimental sessions.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: