Cannabis for Opioid Use Disorder

PN
Overseen ByPaul Nuzzo
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Shanna Babalonis, PhD

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether cannabis can reduce the urge to use opioids in individuals with opioid use disorder. Participants will stay at the University of Kentucky Hospital for about six weeks and try different treatments, including cannabis and opioids. The study will compare the effects of real cannabis versus a placebo (a substance with no active drug) to determine any differences. The trial seeks individuals with moderate to severe opioid use disorder who experience withdrawal symptoms and are willing to stay in the hospital for the study's duration. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this potentially groundbreaking treatment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that cannabis might help reduce opioid use and improve outcomes for people with opioid use disorder. Research suggests it can lessen withdrawal symptoms and lower the chances of misusing opioids. Access to cannabis has also been linked to fewer opioid prescriptions and overdose deaths.

Cannabis is generally well-tolerated in terms of safety, though some people might experience side effects like dizziness or dry mouth. Importantly, using cannabis does not seem to increase the risk of returning to non-medical opioid use for those in treatment.

This clinical trial is in its early phase, focusing on safety. Early-phase trials often begin with small groups to closely monitor side effects and ensure the treatment is safe for participants.12345

Why are researchers excited about this trial's treatments?

Cannabis is unique in the treatment of opioid use disorder because it offers a new mechanism of action that could potentially reduce dependency by interacting with the body's endocannabinoid system. Unlike traditional treatments such as methadone or buprenorphine, which are opioid agonists that work by partially activating opioid receptors, cannabis might help manage cravings and withdrawal symptoms without directly interacting with these receptors. Researchers are excited about this approach as it could provide a novel pathway to manage opioid dependence with potentially fewer side effects and a lower risk of addiction.

What evidence suggests that this trial's treatments could be effective for opioid use disorder?

This trial will compare active cannabis with placebo cannabis for opioid use disorder. Research on cannabis for opioid use disorder has shown mixed results. Some studies suggest that medicinal cannabis might help reduce cravings and withdrawal symptoms, potentially lowering opioid use by 25%. However, other research indicates that people who use cannabis may be more likely to use opioids and start using them later on. Evidence also suggests that opening cannabis dispensaries can lead to fewer opioid prescriptions. Despite these findings, many studies show no clear impact of cannabis on treatment outcomes like relapse or adherence to a treatment plan.13467

Who Is on the Research Team?

SB

Shanna Babalonis, PhD

Principal Investigator

University of Kentucky, College of Medicine

Are You a Good Fit for This Trial?

This trial is for adults with opioid use disorder who are willing to stay in the hospital for 6 weeks. Participants must be able to safely receive both cannabis and opioids under medical supervision.

Inclusion Criteria

Participants with moderate to severe opioid use disorder who experience opioid withdrawal
No allergies or adverse reactions to cannabis or opioids
I am willing to stay in the hospital for about 6 weeks for the study.

Exclusion Criteria

Individuals seeking treatment for opioid use disorder

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Inpatient Treatment

Participants reside at the University of Kentucky Hospital for a 6-week inpatient trial, receiving double-blind doses of cannabis and opioids.

6 weeks
Continuous inpatient stay

Crossover Treatment Period

Participants receive active or placebo cannabis three times daily for approximately 16 days, completing sample and self-administration sessions with opioids.

16 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Cannabis
  • Intranasal Opioid Agonist
  • Oral Opioid Agonist
  • Placebo Cannabis

Trial Overview

The study tests whether using cannabis (compared to placebo) affects how much people with opioid use disorder want or choose to take opioids. Both real and fake cannabis, as well as different forms of opioids, will be given in a double-blind setup.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Active CannabisExperimental Treatment3 Interventions
Group II: Placebo CannabisPlacebo Group3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Shanna Babalonis, PhD

Lead Sponsor

Trials
5
Recruited
140+

Citations

Cannabis for Opioid Use Disorder - NCBI Bookshelf

No evidence of an impact of cannabis on quality of life, functioning, satisfaction, relapse, hospitalizations, or overdoses in people with opioid use disorder ...

Cannabis Legalization and Opioid Use Disorder in ...

OUD decreased from 1.12% to 1.06% in states without cannabis laws, increased from 1.13% to 1.19% in states that enacted MCL, and remained ...

For Opioid Use Disorder, Does Cannabis Produce Harm or ...

Cannabis users had 3.5 times greater odds of any opioid use and 2.6 times greater odds of new-onset opioid use 3 years later.

The Role of Medicinal Cannabis as an Emerging Therapy for ...

medicinal cannabis may have efficacy in reducing cravings and withdrawal effects, there is a reported 25% reduction in mean annual opioid ...

Access to medical, recreational cannabis reduces opioid use

The researchers found medical and recreational cannabis dispensary openings were associated with significant reductions in all opioid outcomes.

Medical cannabis for opioid use disorder: The association ...

Recent research suggests that cannabis has the potential to reduce withdrawal symptoms and prevent opioid misuse and relapse, but this literature is also ...

Relationship Between Marijuana and Opioids

Cannabis access is associated with reduced rates of opioid use and abuse, traffic fatalities, drug treatment admissions, and overdose deaths.