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NCT Number: NCT06948136

Acute Effects of THC in Older Adult

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.

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Key information

Conditions

Age-related Cognitive Decline

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

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

Primary outcomes

  1. 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.

    The task consists of 5 trials, an interference list, free delayed recall, and recognition.

Secondary outcomes

  1. Visual Analog Scale (VAS)

    Time frame: -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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ashley Schnakenberg Martin, PhD

CONTACT

[email protected]

Deepak C D'Souza

CONTACT

[email protected]

203-932-5711 ext. 12594

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: THC-Aging

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 29, 2025
Registry last updated
Aug 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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