← Back to Search

Marijuana + Opioids for Opioid Use Disorder

Phase 1
Waitlist Available
Research Sponsored by Shanna Babalonis, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Healthy adults ages 18-50
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up these outcomes (visual analog scores, scale of 0-100) will be recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).
Awards & highlights

Study Summary

This trial will study the effects of marijuana and opioids, alone and in combination, on abuse-related measures and physiological outcomes.

Who is the study for?
This trial is for healthy adults aged 18-50 who currently use opioids and marijuana without medical guidance. It's not open to those with opioid dependence, alcohol or sedative addiction, significant health issues, or individuals actively seeking drug treatment.Check my eligibility
What is being tested?
The study tests how vaporized marijuana and an opioid agonist interact when taken alone or together. Researchers will look at participants' subjective feelings towards the drugs and measure physiological responses to understand these interactions.See study design
What are the potential side effects?
Possible side effects may include changes in mood, altered sensory perceptions from marijuana use, and typical opioid-related effects such as drowsiness, nausea, constipation, and potential for increased abuse risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a healthy adult between 18 and 50 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~these outcomes (visual analog scores, scale of 0-100) will be recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).
This trial's timeline: 3 weeks for screening, Varies for treatment, and these outcomes (visual analog scores, scale of 0-100) will be recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Subject-Rated Outcomes
Secondary outcome measures
Change in Blood pressure
Change in Oxygen Saturation
Change in Respiration Rate

Trial Design

3Treatment groups
Experimental Treatment
Group I: Vaporized MarijuanaExperimental Treatment1 Intervention
Participants will receive non-therapeutic, experimental doses of active or placebo. vaporized marijuana. Active marijuana/placebo will be administered once per session and will be administered via a vaporizer.
Group II: Opioid Agonist/Marijuana CombinationExperimental Treatment2 Interventions
Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with non-therapeutic, experimental doses of active vaporized marijuana/placebo. Opioid/placebo and marijuana/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer.
Group III: Opioid AgonistExperimental Treatment1 Intervention
Participants will receive non-therapeutic, experimental doses of an active opioid agonist or placebo. Active opioid agonist/placebo will be administered once per session and will be administered intranasally (snorting).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Medical Cannabis
Not yet FDA approved
Opioid Agonist
2019
Completed Phase 1
~40

Find a Location

Who is running the clinical trial?

Shanna Babalonis, PhDLead Sponsor
2 Previous Clinical Trials
46 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,447 Previous Clinical Trials
2,594,057 Total Patients Enrolled

Media Library

Opioid Agonist Clinical Trial Eligibility Overview. Trial Name: NCT03705559 — Phase 1
Opioid Use Disorder Research Study Groups: Opioid Agonist/Marijuana Combination, Vaporized Marijuana, Opioid Agonist
Opioid Use Disorder Clinical Trial 2023: Opioid Agonist Highlights & Side Effects. Trial Name: NCT03705559 — Phase 1
Opioid Agonist 2023 Treatment Timeline for Medical Study. Trial Name: NCT03705559 — Phase 1
Opioid Use Disorder Patient Testimony for trial: Trial Name: NCT03705559 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total number of participants involved in this clinical trial?

"Affirmative. Per the details on clinicaltrials.gov, this medical study is actively seeking participants. It was originally posted to the site in June 2019 and its most recent update was made October 2021; 105 patients are being recruited from a single location."

Answered by AI

Are there any potential risks associated with Opioid Agonist treatment?

"This medication has been subject to limited clinical research, so it was given a rating of 1 for safety. This Phase 1 trial is still in the early stages and only provides partial data on efficacy and overall protection."

Answered by AI

Are there any openings in this clinical research study at the moment?

"As current records on clinicaltrials.gov demonstrate, this trial is actively seeking participants to enrol in their study. It was first announced June 21st 2019 and the latest update was posted October 21 2022."

Answered by AI

Could you please provide an overview of other research conducted involving Opioid Agonist?

"At present, 31 clinical trials related to Opioid Agonists are in progress with 3 of those studies at Phase 3. Notably, there are 46 total sites running these experiments; many located within Hartford, Connecticut."

Answered by AI

Might I be eligible to partake in this clinical trial?

"For this research initiative, 105 adults aged between 18 and 50 with existing marijuana use are necessary. Applicants must fulfill the following prerequisites: Adults in good health age 18-50, Current non-clinical consumption of opioids and cannabis."

Answered by AI

Is this investigation a pioneering endeavor?

"At present, there are 31 studies for opioid agonist being conducted in 32 cities and 5 countries. The inaugural trial, sponsored by Jazz Pharmaceuticals, was initiated in 2015 and saw 200 patients through Phase 2 & 3 clinical trials. Since then, a further 60 investigations have been carried out."

Answered by AI

Does this research offer an opportunity to those above the age of fifty?

"This trial's criteria states that patients must be between 18 to 50 years old. Additionally, there are 32 studies for minors and 179 trials for seniors over 65."

Answered by AI

Who else is applying?

What state do they live in?
Kansas
Alabama
California
Other
How old are they?
18 - 65
What site did they apply to?
University of Kentucky
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
1
3+

Why did patients apply to this trial?

I've tried many ways to get opioid and continue to fail. I have severe backpain and depression. Id like to help study the effects of cannabis and thc on this conditions if it helps legalization and reform.
PatientReceived 2+ prior treatments
~2 spots leftby Mar 2025