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Recruiting Phase 1 NCT06948136

NCT06948136 Acute Effects of THC in Older Adult

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Clinical Trial Summary
NCT ID NCT06948136
Status Recruiting
Phase Phase 1
Sponsor Yale University
Condition Age-related Cognitive Decline
Study Type INTERVENTIONAL
Enrollment 60 participants
Start Date 2025-06-06
Primary Completion 2027-11-01

Eligibility & Interventions

Sex All sexes
Min Age 21 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
Delta-9-THC Low DosePlaceboDelta-9-THC Medium Dose

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 60 participants in total. It began in 2025-06-06 with a primary completion date of 2027-11-01.

⚠ 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

The primary objective of this study is to determine if increasing age confers greater vulnerability to the acute A) cognitive (e.g., memory, attention, psychomotor function), B) subjective (e.g., anxiogenic and rewarding effects), and C) cardiovascular (heart rate and blood pressure), effects of THC in adults \> 21 years old. The secondary aims of the study are to explore age-related acute effects of THC on electrophysiological indices of information processing (e.g., auditory steady-state response (ASSR), oddball paradigm \[P300\], and resting state cortical noise) and to determine age-related differences in the metabolism of THC.

Eligibility Criteria

* Ability to provide informed consent * No history (current or past) of unstable or serious medical, neurological or psychiatric conditions. * High school education or greater * No positive pregnancy test and/or lactation/ planning to nurse while in this study * English speaking

Contact & Investigator

Central Contact

Deepak C D'Souza

✉ deepak.douza@yale.edu

📞 203-932-5711

Principal Investigator

Deepak C D'Souza, MD

PRINCIPAL INVESTIGATOR

Yale University School of Medicine; VA Connecticut Healthcare System

Frequently Asked Questions

Who can join the NCT06948136 clinical trial?

This trial is open to participants of all sexes, aged 21 Years or older, studying Age-related Cognitive Decline. 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 NCT06948136 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 NCT06948136 currently recruiting?

Yes, NCT06948136 is actively recruiting participants. Contact the research team at deepak.douza@yale.edu for enrollment information.

Where is the NCT06948136 trial being conducted?

This trial is being conducted at West Haven, United States.

Who is sponsoring the NCT06948136 clinical trial?

NCT06948136 is sponsored by Yale University. The principal investigator is Deepak C D'Souza, MD at Yale University School of Medicine; VA Connecticut Healthcare System. The trial plans to enroll 60 participants.

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