Acute Effects of THC in Older Adult

Phase 1

Not yet recruiting

• Conditions: Age-related Cognitive Decline
• Interventions: Drug: Delta-9-THC; Drug: Placebo

• Registration Number: NCT06948136
• Lead Sponsor: Yale University

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. It is hypothesized that increasing age will confer greater vulnerability to THC-induced cognitive impairments, anxiogenic effects, and cardiovascular effects but are less vulnerability to its rewarding effects. Increasing age will confer greater vulnerability to THC-induced deficits in electrophysiological indices of information processing including.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-21
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-23
• Last Update Submitted: 2025-04-23
• Study First Posted: 2025-04-29
• Last Update Posted: 2025-04-29
• Study Start: 2025-05-30
• Primary Completion: 2027-11-01
• Study Completion: 2027-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Delta-9-THC	Delta-9-THC	Active delta-9-THC (0.03 mg/kg) administered intravenously over 20 minutes.
Placebo	Placebo	Control: Small amount of alcohol administered intravenously (quarter teaspoon), with no delta-9-THC, over 20 minutes.

Primary Outcome Measures

Name	Time	Method
Rey Auditory Verbal Learning Task (RAVLT) total immediate recall	Each test day will be split into two drug administration sessions. The RAVLT will be administered approximately 25 minutes after each drug administration.	The task consists of 5 trials, an interference list, free delayed recall, and recognition.

Secondary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS)	-60 minutes, 20 minutes, 60 minutes, 120 minutes, 170 minutes, 210 minutes, 270 minutes, 300 minutes, 360 minutes, 420 minutes after the start of the initial THC/placebo drug infusion.	Various feeling states will be measured using a self-reported visual analog scale of feeling states (ex: "calm and relaxed", and "tired") associated with drug administration. Subjects will be asked to score the perceived intensity of these feeling states at that moment on a 100 mm line (0 = not at all, 100 = extremely). A higher score reflects a positive response.

Trial Locations

Locations (1)

VA Connecticut Healthcare System; 🇺🇸 West Haven, Connecticut, United States