Dronabinol for Cannabis Use Disorder
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.12345Why 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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either THC or a placebo, complete questionnaires, and undergo a 1-hour brain scan
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medical University of South Carolina
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
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 ...
2.
cannabisevidence.org
cannabisevidence.org/clinician-resources/clinician-briefs/treatments-for-cannabis-use-disorder/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 ...
3.
researchgate.net
researchgate.net/publication/5459708_Use_of_Dronabinol_for_Cannabis_Dependence_Two_Case_Reports_and_ReviewUse 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.
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.
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