NCT06055309

Behavioral Pharmacology of Cannabis in Older Adults

Behavioral Pharmacology of Cannabis in Older Adults: A Pilot Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: University of Arkansas · Academic / Other
• Sex: All
• Age: 55 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This study examines the effects of cannabis on mood, cognitive and psychomotor performance, balance and vital signs in older adults.

Detailed description

The overarching aims of this pilot study are to determine the dose-related effects of cannabis and explore feasibility and acceptability of conducting a rigorous behavioral pharmacology study in this population. Using a within-subject design in older adults (55-70 years), this study will (1) determine acute dose-related effects of cannabis on physiological, subjective, cognitive, and psychomotor measures and (2) explore acceptability/feasibility of this approach among older adults in order to refine procedures for future studies. Volunteers (55-70 years) will undergo three 7.5-hour experimental sessions conducted one week apart, in which they receive cannabis containing various oral doses of tetrahydrocannabinol (THC) / cannabidiol (CBD) administered in a brownie formulation and the following are assessed: 1) self-reported and/or observer ratings of positive and negative subjective effects; 2) performance effects, measured by reaction time, coordination, and cognitive impairment; and 3) cardiovascular effects. Participants will be contacted the day after each session for feedback on the acceptability of session length, types, number and duration of tasks and any adverse events. Reasons for dropout will also be sought to determine whether study procedures impacted attrition. Findings will: 1) provide investigative team with the hands-on research cannabis research experience; 2) elucidate the optimal THC dose range; and 3) determine the most feasible/acceptable study design in older adults that will inform further rigorous studies examining acute and chronic administration of cannabis formulations among older adults.

Conditions

• Health Services for the Aged

Interventions

Type	Name	Description
DRUG	Cannabis (up to three doses)	a dose of cannabis will be baked into brownies

Timeline

• Start date: 2025-05-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2023-09-26
• Last updated: 2026-01-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study