Acute Effects of THC in Older Adult

Part of paid clinical trials in West Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT06948136
Phase
PHASE1
Status
Recruiting
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Conditions

  • Age-related Cognitive Decline

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Delta-9-THC Low Dose — DRUG
    Active Delta-9-THC administered intravenously over 20 minutes.
  • Placebo — DRUG
    Small amount of sterile ethanol (1-2 mLs), with no THC, administered intravenously over 20 minutes.
  • Delta-9-THC Medium Dose — DRUG
    Active Delta-9-THC administered intravenously over 20 minutes

Study Details

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.

Key Dates

Start date
Jun 6, 2025
Status verified
Aug 2025
Primary completion
Nov 1, 2027
Completion
Nov 1, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
VA Connecticut Healthcare SystemWest HavenConnecticut06516-

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By research site
VA Connecticut Healthcare System· West Haven, CT

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