Acute Effects of THC in Older Adult

Study acronym: THC-Aging
StatusRecruiting
PhasePhase 1
Started

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Record History

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  1. Minor Study completion pushed from Nov 1, 2027 to Nov 1, 2028
    • Secondary endpoints: details revised at 1 of 1 entry
    • Site contact updated
    • Eligibility criteria expanded, about 5 words
  2. Minor Eligibility criteria shortened, about 80 wordsv4
  3. Minor Interventions: Delta-9-THC (Drug), Placebo (Drug) to Delta-9-THC Low Dose (Drug), Delta-9-THC Medium Dose (Drug), Placebo (Drug)
    • Study arms: 2 to 3
    v3
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 30, 2025 to Jun 6, 2025
    • Site details revised
    v2
  5. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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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.
Trial Details
NCT Number NCT06948136
Lead Sponsor Yale University
Collaborators: National Institute on Drug Abuse (NIDA)
Conditions
(from sponsor)
Age-related Cognitive Decline
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov