Actively Recruiting

Phase 1
Age: 21Years +
All Genders
Healthy Volunteers
ID06948136

Acute Effects of THC in Older Adult

Led by Yale University ยท Updated on 2025-08-18

60

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

Y

Yale University

Lead Sponsor

N

National Institute on Drug Abuse (NIDA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying how increasing age affects the immediate impact of THC on memory, attention, psychomotor function, feelings of anxiety or reward, and heart rate and blood pressure in adults over 21 years old. The study also explores how age influences the brain's electrical activity during information processing and differences in THC metabolism. This trial is conducted by Yale University and is a Phase 1 randomized study. Participants receive either a low or medium dose of delta-9-THC or a placebo, all administered intravenously over 20 minutes. The placebo consists of a small amount of sterile ethanol without THC. Each test day includes two drug administration sessions where these treatments are given, allowing comparison of the effects at different doses and against placebo. During the study, participants will complete memory tests such as the Rey Auditory Verbal Learning Task approximately 25 minutes after each drug administration. They will also provide subjective feedback on various effects through Visual Analog Scales at multiple time points up to 420 minutes after infusion. The trial monitors cognitive, subjective, and cardiovascular responses to THC to understand age-related differences, with participation involving multiple assessments on test days.

CONDITIONS

Brief Title

Acute Effects of THC in Older Adult

Who Can Participate

Age: 21Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Each test day involves two drug administration sessions with assessments up to 7 hours post-infusion.

Participants receive intravenous doses of Delta-9-THC or placebo in separate sessions with evaluations after each administration.

Each test day includes 2 intravenous infusions over 20 minutes each, with multiple assessments up to 7 hours after the first infusion.

Trial Site Locations

Total: 1 location

1

VA Connecticut Healthcare System

West Haven, Connecticut, United States, 06516

Actively Recruiting

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Research Team

D

Deepak C D'Souza

A

Ashley Schnakenberg Martin, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

OTHER

Number of Arms

3

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