Acute Effects of THC in Older Adult (THC-Aging)

Yale University

Status and phase: Enrolling; Phase 1

Conditions: Age-related Cognitive Decline

Treatments: Drug: Delta-9-THC Medium Dose; Drug: Delta-9-THC Low Dose; Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06948136

2000038388

1R21DA058138-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 21 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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60 participants in 3 patient groups, including a placebo group

Delta-9-THC Very Low Dose

Active Comparator group

Description:

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

Treatment:

Drug: Delta-9-THC Low Dose

Placebo

Placebo Comparator group

Description:

Control: Small amount of alcohol administered intravenously (quarter teaspoon), with no delta-9-THC, over 20 minutes.

Treatment:

Drug: Placebo

Delta-9-THC Medium Dose

Active Comparator group

Description:

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

Treatment:

Drug: Delta-9-THC Medium Dose