78 Participants NeededMy employer runs this trial

Dronabinol for Cannabis Use Disorder

EM
Overseen ByErin Martin, Ph.D.
Age: 18 - 65
Sex: Any
Trial Phase: Phase 2
Sponsor: Medical University of South Carolina
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how men and women respond differently to cannabis, using dronabinol (a synthetic form of THC) to determine its effects on frequent cannabis users. Participants will visit the study center three times to receive either THC, the active component in cannabis, or a placebo. During these visits, they will complete questionnaires, undergo a brain scan, and one visit will include a blood draw for genetic testing. This trial is suitable for individuals aged 21-45 who use cannabis at least four days a week and are not currently seeking treatment for cannabis use. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant findings in cannabis research.

Is there any evidence suggesting that Dronabinol is likely to be safe for humans?

Previous studies have shown that dronabinol, a synthetic version of THC (the main active component of cannabis), is generally safe for patients. The FDA has approved dronabinol for other uses, such as treating nausea in cancer patients and aiding appetite in individuals with HIV/AIDS. This approval indicates its safety when used correctly for these conditions.

Some participants might experience side effects, typically mild ones like dizziness, dry mouth, or fatigue. Serious side effects are rare. As this trial is in an early stage, researchers are still carefully studying the treatment's safety, but past research suggests it is manageable for most people.12345

Why do researchers think this study treatment might be promising for cannabis use disorder?

Dronabinol is unique because it directly targets the endocannabinoid system, offering a novel approach to treating Cannabis Use Disorder (CUD). Unlike standard treatments like cognitive behavioral therapy or certain medications used off-label, dronabinol is a synthetic form of THC, the primary psychoactive component of cannabis, which may help reduce withdrawal symptoms and cravings. Researchers are excited about dronabinol because it could provide a targeted mechanism of action that directly addresses the neurochemical imbalances associated with cannabis dependency, potentially offering a more effective intervention than current options.

What evidence suggests that Dronabinol might be an effective treatment for Cannabis Use Disorder?

Studies have shown that dronabinol, a synthetic version of THC, can help reduce withdrawal symptoms for individuals trying to quit cannabis. Research also suggests it may improve the likelihood of remaining in treatment programs. In some cases, dronabinol has eased symptoms of cannabis dependence, making it a promising option for those with cannabis use disorder. Early findings indicate it could help manage cravings and lower the risk of relapse. Participants in this trial will receive dronabinol, with separate treatment arms for males and females to assess any differences in response.678910

Are You a Good Fit for This Trial?

This trial is for men and women who use cannabis at least 4 days a week. Participants must be willing to attend three in-person visits, including brain scans and blood draws. People with certain health conditions or on conflicting medications may not be eligible.

Inclusion Criteria

BMI between 18-30 kg/m2
I am willing to use non-hormonal birth control during the study.
Able and willing to provide informed consent
See 5 more

Exclusion Criteria

Allergy to sesame oil
Meet DSM-5 criteria for any current psychiatric disorder other than nicotine or caffeine use disorder, mild alcohol use disorder, CUD, or ADHD
MRI contraindications (e.g., metallic implants, claustrophobia)
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 visit
1 visit (in-person)

Treatment

Participants receive either THC or a placebo, complete questionnaires, and undergo a 1-hour brain scan

2 visits
2 visits (in-person, 7 hours each)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Dronabinol

Trial Overview

The study compares the effects of dronabinol (a form of THC) versus a placebo in regular cannabis users, looking at differences between men and women through questionnaires, brain scans, and genetic testing over multiple visits.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: MalesExperimental Treatment2 Interventions
Group II: FemalesExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials
994
Recruited
7,408,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

Citations

Current Treatments for Cannabis Use Disorder

Dronabinol is an oral synthetic THC, and it has an withdrawal, was shown to reduce cannabis withdrawal in a laboratory model of relapse when ...

Treatments for Cannabis Use Disorder

An RCT of 188 participants found that MET treatment was associated with fewer dependence symptoms and less cannabis use at 1 year follow-up. · MET has been shown ...

Use of Dronabinol for Cannabis Dependence: Two Case ...

Based on recent laboratory studies, dronabinol (delta‐9‐tetrahydrocannabinol) has been shown to reduce cannabis withdrawal symptoms and the ...

Treatments for Cannabis Use Disorder across the Lifespan

Treatments for CUD have demonstrated relative efficacy, particularly in alleviating withdrawal symptoms, dronabinol) [33,36,37] impacting ...

Cannabis Use Disorders | Springer Nature Link

Primary outcomes in two randomized controlled trials of treatments for cannabis use disorders. Cannabis dependence: its nature, consequences, and treatment.

Addiction

Outcomes vary widely: an estimated 35–54% of people with a substance use disorder reach remission, though typically only after many years.

What is addiction?

Cannabis — using too much can lead to dependency and affect your mental health. Stimulants — harm your physical and mental health. very dangerous and can harm ...

Addiction Science | National Institute on Drug Abuse (NIDA)

Drug addiction is a complex medical condition. Learn more about the science of and research into addiction, health, and the brain.

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addictionjournal.org

addictionjournal.org/

Addiction Journal | Peer-Reviewed Addiction Research

One in nine older US adults who have used cannabis in the past 12 months meets the criteria for cannabis use disorder. have declined from 2019; remained ...

Addiction: what is it? - NHS

An overview of what addiction is, the various types of addictions, and how they can be treated.