NCT06058702 Genetics of Cannabis Use Disorder and Cannabinoid Response in Humans
| NCT ID | NCT06058702 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Yale University |
| Condition | Schizophrenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 215 participants |
| Start Date | 2024-09-16 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 215 participants in total. It began in 2024-09-16 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: -Ages 21-60 years old Exclusion Criteria: * Major or unstable medical conditions based on history, the Structured Clinical Interview for DSM-5, collateral information, physical and laboratory examinations, ECG, and vital signs. * Cannabis naïve individuals * Positive pregnancy test
Contact & Investigator
Deepak D'Souza, MD
PRINCIPAL INVESTIGATOR
Yale University
Frequently Asked Questions
Who can join the NCT06058702 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 60 Years, studying Schizophrenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06058702 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06058702 currently recruiting?
Yes, NCT06058702 is actively recruiting participants. Contact the research team at deepak.douza@yale.edu for enrollment information.
Where is the NCT06058702 trial being conducted?
This trial is being conducted at West Haven, United States.
Who is sponsoring the NCT06058702 clinical trial?
NCT06058702 is sponsored by Yale University. The principal investigator is Deepak D'Souza, MD at Yale University. The trial plans to enroll 215 participants.
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