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; 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. 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 21 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

• at least one lifetime use of cannabis and/or THC in the past ten years
• negative urine screen for illicit substance use
• no other illicit substance use during the past three months
• not nicotine dependent (5 cigarettes per day; score of 3 on the Fagerstrom Test for Nicotine Dependence)
• alcohol use ≤ 7 drinks/week in women and 14 in men
• no current or past serious mental illness (e.g., schizophrenia, bipolar and related disorders, etc.) diagnosed with the use of the diagnostic and statistical manual of mental disorders (DSM-5)
• no family history of psychosis
• no history of significant medical or neurological disease per PI discretion
• BMI ≤ 32
• high school education or greater
• no positive pregnancy test and/or lactation
• English speaking

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Delta-9-THC

Active Comparator group

Description:

Active delta-9-THC (0.03 mg/kg) administered intravenously over 20 minutes.

Treatment:

Drug: Delta-9-THC

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