Cannabis Effects on Opioid Self-Administration

ConditionsOpioid Use Disorder Cannabis Use

Trial statusNot yet recruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-55

SponsorShanna Babalonis, PhD

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Individuals seeking treatment for opioid use disorder

Trial design

Design model

Crossover

Treatments tested in this trial

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

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: Active CannabisExperimental treatment 3 interventions

Group B: Placebo CannabisPlacebo comparator 3 interventions

Trial outcomes

Primary outcomes

Number of Opioid Self-Administration Trials Completed

Number of drug-choice trials completed for intranasal opioid agonists during self-administration sessions.

Time frame

Up to 6.5 Weeks

Sponsors and contacts

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

Shanna Babalonis, PhD

Lead sponsor

University of Kentucky

Sponsor institution

Source ClinicalTrials.gov

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