215 Participants Needed

Genetics and Cannabinoid Response for Cannabis Use Disorder

DD
CH
CL
Overseen ByChristina Luddy, BS
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Yale University
Approved in 5 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

Cannabis is widely used worldwide and is associated with negative outcomes including cannabis use disorder (CanUD), psychosis, and cognitive impairment amongst others. Given the legalization of "recreational" and "medical" cannabis globally, the increasing availability of cannabis, the higher potency of cannabis, the availability of highly potent cannabinoid products, the commercialization of cannabis, and the rising rates of cannabis use, it is critical to understand how genetic factors influence 1) an individual's vulnerability for addiction and psychosis, 2) the response to cannabinoids, 3) the response to novel treatments for CanUD. CanUD is strongly genetically influenced; the investigators published the first CanUD genomewide association study (GWAS) with genomewide-significant results; however, the precise nature of the contribution of genetic factors in the development of CanUD is still not clear. Cannabis exposure has also been linked to a number of psychosis outcomes including schizophrenia (SCZ). SCZ is highly heritable and population-based and genetics studies both support a bidirectional genetic relationship between SCZ and CanUD. However, the precise contribution of genetic factors in the development of psychosis outcomes related to cannabis are not clear.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is Delta-9-THC generally safe for human use?

Research suggests that Delta-9-THC, when used in a controlled and monitored setting, has a reasonable safety profile for medical purposes, with most adverse effects being mild to moderate. However, it can cause some acute effects like increased heart rate, low blood pressure when standing, and mental effects such as anxiety or paranoia, so monitoring is important.12345

How is the drug Delta-9-THC unique in treating cannabis use disorder?

Delta-9-THC (Dronabinol) is unique because it directly targets the same cannabinoid receptors in the brain that are affected by cannabis, potentially helping to reduce withdrawal symptoms and cravings. This approach is different from other treatments that may not directly interact with these specific receptors.678910

Who Is on the Research Team?

DD

Deepak D'Souza, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for people aged 18-60 who have used cannabis and may struggle with addiction (CanUD) or have experienced psychosis. It's not for those with major health issues, no history of cannabis use, or pregnant individuals.

Exclusion Criteria

Positive pregnancy test
I do not have any major or unstable health conditions.
Cannabis naïve individuals

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either active delta-9-THC or placebo intravenously over 20 minutes

1 day
1 visit (in-person)

Assessment

Participants are assessed using various scales including PANSS, VAS, CADSS, and CogState Battery at multiple time points after drug infusion

6 hours
1 visit (in-person)

Follow-up

Participants are monitored for any delayed effects or adverse reactions post-treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Delta-9-THC
Trial Overview Researchers are testing the effects of Delta-9-THC (the active component in cannabis) against a placebo to understand how genetics influence addiction, response to cannabinoids, and potential treatments for CanUD.
How Is the Trial Designed?
3Treatment groups
Active Control
Placebo Group
Group I: Delta-9-THC Very Low DoseActive Control1 Intervention
Group II: Delta-9-THC Medium DoseActive Control1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Delta-9-THC is already approved in United States, Canada for the following indications:

🇺🇸
Approved in United States as Marinol for:
🇺🇸
Approved in United States as Syndros for:
🇨🇦
Approved in Canada as REDUVO for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials
1,963
Recruited
3,046,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

Published Research Related to This Trial

A study involving 431 individuals with chronic non-cancer pain found that using a standardized herbal cannabis product for one year did not increase the risk of serious adverse events compared to non-users, suggesting a reasonable safety profile for medical cannabis.
However, cannabis users experienced a higher rate of non-serious adverse events, mostly mild to moderate, indicating that while cannabis may be safe for serious complications, it can still lead to some side effects that need to be monitored.
Cannabis for the Management of Pain: Assessment of Safety Study (COMPASS).Ware, MA., Wang, T., Shapiro, S., et al.[2022]
The metabolism of THC is significantly influenced by genetic variations in the CYP2C9 enzyme, with individuals carrying the CYP2C9*3 variant showing reduced exposure to the active metabolite THC-COOH, which may have therapeutic implications.
THC is primarily cleared from the body through liver metabolism, and its clearance is dependent on liver blood flow rather than protein binding, indicating that the route of administration (IV or inhalation) does not significantly affect THC elimination.
Minimal Physiologically Based Pharmacokinetic Model of Intravenously and Orally Administered Delta-9-Tetrahydrocannabinol in Healthy Volunteers.Wolowich, WR., Greif, R., Kleine-Brueggeney, M., et al.[2020]
The safety of cannabis and cannabinoid medications is a significant concern, and while some safety information can be drawn from recreational use studies, medical and recreational users may experience different effects.
There is a pressing need for long-term safety monitoring of cannabinoid use in patients, as clinical experience is still developing, which will help inform both therapeutic decisions and public policy.
Safety issues concerning the medical use of cannabis and cannabinoids.Ware, MA., Tawfik, VL.[2019]

Citations

Cannabis for the Management of Pain: Assessment of Safety Study (COMPASS). [2022]
Minimal Physiologically Based Pharmacokinetic Model of Intravenously and Orally Administered Delta-9-Tetrahydrocannabinol in Healthy Volunteers. [2020]
Safety issues concerning the medical use of cannabis and cannabinoids. [2019]
Methods for clinical research involving cannabis administration. [2019]
Consumer Experiences with Delta-8-THC: Medical Use, Pharmaceutical Substitution, and Comparisons with Delta-9-THC. [2023]
The genetic aetiology of cannabis use: from twin models to genome-wide association studies and beyond. [2023]
High genes: Genetic underpinnings of cannabis use phenotypes. [2021]
Genetic and Environmental Factors Associated with Cannabis Involvement. [2023]
Genetic Factors in Cannabinoid Use and Dependence. [2019]
A large-scale genome-wide association study meta-analysis of cannabis use disorder. [2023]
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