Recruiting
Phase 1

THC

Sponsor:

Yale University

Code:

NCT06948136

Conditions

Age-related Cognitive Decline

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Interventions

Delta-9-THC Low Dose

Placebo

Delta-9-THC Medium Dose

Study Details

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.

Conditions

Age-related Cognitive Decline

Study ID

NCT06948136

Start date

Jun 6, 2025

Status verified date

Aug, 2025

Completion date

Nov 1, 2027

Anticipated

Primary completion date

Nov 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

  • 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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Delta-9-THC Very Low Dose

Active delta-9-THC administered intravenously over 20 minutes.

placebo comparator: Placebo

Control: Small amount of alcohol administered intravenously (quarter teaspoon), with no delta-9-THC, over 20 minutes.

active comparator: Delta-9-THC Medium Dose

Active delta-9-THC administered intravenously over 20 minutes.

Interventions

Delta-9-THC Low Dose

Active Delta-9-THC administered intravenously over 20 minutes.

Placebo

Small amount of sterile ethanol (1-2 mLs), with no THC, administered intravenously over 20 minutes.

Delta-9-THC Medium Dose

Active Delta-9-THC administered intravenously over 20 minutes

Primary outcome measure

  • Rey Auditory Verbal Learning Task (RAVLT) total immediate recall [ Time Frame: Each test day will be split into two drug administration sessions. The RAVLT will be administered approximately 25 minutes after each drug administration. ]

Central Contacts and Locations

Central contacts

Deepak C D'Souza

203-932-5711deepak.douza@yale.edu

Ashley Schnakenberg Martin, PhD

ashley.martin@yale.edu

Locations

VA Connecticut Healthcare System

Recruiting

West Haven, Connecticut, United States, 06516

More Information

Sponsor

Yale University

Last update posted

Aug 18, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2025-08-18.