144 Participants Needed

THC for Cannabis Use

(RiDE-2 Trial)

NC
Overseen ByNatania Crane, PhD
Age: 18 - 65
Sex: Any
Trial Phase: Phase < 1
Sponsor: University of Illinois at Chicago

Trial Summary

Will I have to stop taking my current medications?

Yes, you will need to stop taking any medication that could interact with a single dose of Δ9-THC.

What data supports the effectiveness of the drug THC for cannabis use?

THC, a major component of cannabis, is used in FDA-approved drugs like nabiximols to help with pain and muscle stiffness in multiple sclerosis, and dronabinol for nausea in cancer patients and appetite loss in AIDS patients. This suggests THC can have therapeutic effects, although its use is limited by its mind-altering properties.12345

Is THC generally safe for human use?

Cannabis sativa (marijuana), which contains THC, has been frequently reported in safety databases for being associated with adverse events. While not all reports are confirmed adverse events, this suggests there may be safety concerns that require further investigation.678910

How is the drug THC unique for treating cannabis use?

THC is unique because it is the main psychoactive component of cannabis and is being studied for its potential to help manage cannabis use itself, which is different from other treatments that might not directly involve cannabinoids. This approach leverages THC's interaction with the body's cannabinoid receptors, which is not a common mechanism in other treatments for cannabis use.1112131415

What is the purpose of this trial?

The purpose of this study is to better understand how people's mood, behavior, and brains respond to different recreational drugs. We are also trying to understand why some people may feel differently or their brain may respond differently than other people after taking the same recreational drug.

Eligibility Criteria

This trial is for healthy individuals interested in how recreational drugs like cannabis affect mood, behavior, and brain response. Participants should not have a history of prescription drug abuse or substance use disorders.

Inclusion Criteria

Body mass index of 18.5-30
I have used cannabis more than 10 times in my life and at least once in the last 3 months, but not every day.
I am in good physical and mental health.
See 1 more

Exclusion Criteria

Unwilling/unable to sign informed consent document
I have tested positive for drugs (except THC) or THC in saliva.
Contraindication for fMRI BOLD study (e.g., metal implants)
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive THC or placebo during the first or second laboratory visit, with fMRI scanning to assess mood, behavior, and brain response

2 visits
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of substance use and CUD/SUD symptoms

2 years
Yearly follow-ups

Treatment Details

Interventions

  • THC
Trial Overview The study is testing the effects of THC (the active ingredient in cannabis) compared to a placebo. Participants will receive either THC or an inactive capsule without knowing which one they are taking.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: THCExperimental Treatment1 Intervention
Participants will receive THC (7.5 mg) at their first or second laboratory visit.
Group II: Placebo oral capsulePlacebo Group1 Intervention
Participants will receive a placebo at their first or second laboratory visit.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials
653
Recruited
1,574,000+

Findings from Research

Cannabinoids from Cannabis sativa, particularly non-psychoactive components like cannabidiol (CBD), have therapeutic potential for various conditions, including pain and spasticity in multiple sclerosis, while minimizing the psychotropic effects of THC.
FDA-approved cannabinoid medications, such as nabiximols, dronabinol, and nabilone, are effective in treating symptoms like chemotherapy-induced nausea and vomiting, and anorexia in AIDS patients, showcasing their clinical relevance across multiple medical fields.
Cannabinoids: Therapeutic Use in Clinical Practice.Pagano, C., Navarra, G., Coppola, L., et al.[2022]
Only about 20% of individuals undergoing treatment for cannabis dependence achieve long-term abstinence, highlighting the need for more effective and accessible treatment options.
Psychotherapeutic strategies, especially combination therapies that include motivational interventions and behavioral skills training, have shown larger effect sizes for cannabis dependence compared to other substance use disorders, indicating their potential effectiveness.
State of the art treatments for cannabis dependence.Danovitch, I., Gorelick, DA.[2021]
In a 2-year observational study of 585 adult patients using medical cannabis, there was a significant increase in the authorization of THC-dominant and CBD-dominant products, indicating a shift in prescribing patterns.
Patients using CBD-dominant or balanced (THC:CBD) products reported greater improvements in anxiety and well-being compared to those using THC-dominant products, suggesting that the cannabinoid profile can influence treatment outcomes.
Authorization Patterns, Safety, and Effectiveness of Medical Cannabis in Quebec.Kalaba, M., MacNair, L., Peters, EN., et al.[2021]

References

Cannabinoids: Therapeutic Use in Clinical Practice. [2022]
Recommendations for Reducing the Risk of Cannabis Use-Related Adverse Psychosis Outcomes: A Public Mental Health-Oriented Evidence Review. [2023]
Exclusive Therapeutic Use of Cannabis in a Large Sample of Daily Cannabis Users in France: A Cross-Sectional Survey. [2023]
State of the art treatments for cannabis dependence. [2021]
Authorization Patterns, Safety, and Effectiveness of Medical Cannabis in Quebec. [2021]
Identifying Herbal Adverse Events From Spontaneous Reporting Systems Using Taxonomic Name Resolution Approach. [2020]
A curated and standardized adverse drug event resource to accelerate drug safety research. [2020]
Post-market surveillance of consumer products: Framework for adverse event management. [2022]
Detection of serious adverse drug reactions using diagnostic codes in the International Statistical Classification of Diseases and Related Health Problems. [2021]
MetaADEDB 2.0: a comprehensive database on adverse drug events. [2021]
[Cannabis and cannabinoids as drugs]. [2018]
Delta9-tetrahydrocannabinol content of commercially available hemp products. [2019]
Delta9-tetrahydrocannabinol (THC), 11-hydroxy-THC, and 11-nor-9-carboxy-THC plasma pharmacokinetics during and after continuous high-dose oral THC. [2021]
14.United Statespubmed.ncbi.nlm.nih.gov
Tetrahydrocannabinol Does Not Reduce Pain in Patients With Chronic Abdominal Pain in a Phase 2 Placebo-controlled Study. [2018]
The safety of studies with intravenous Δ⁹-tetrahydrocannabinol in humans, with case histories. [2021]
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