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Acute Effects of THC in Older Adult

NCT06948136 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-08-18

No results posted yet for this study

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

Interventions

DRUG

Delta-9-THC Low Dose

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

DRUG

Placebo

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

DRUG

Delta-9-THC Medium Dose

Active Delta-9-THC administered intravenously over 20 minutes

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Yale University

    lead OTHER

Principal Investigators

  • Deepak C D'Souza, MD · Yale University School of Medicine; VA Connecticut Healthcare System

  • Ashley Schnakenberg Martin, PhD · Yale University School of Medicine; VA Connecticut Healthcare System

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-06
Primary Completion
2027-11-01
Completion
2027-11-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06948136 on ClinicalTrials.gov