RecruitingEarly Phase 1NCT05906511

PK/PD of Oral and Vaporized Delta-9-Tetrahydrocannabinol (THC) in Older Adults

Pharmacokinetics and Pharmacodynamics of Oral and Vaporized Delta-9-Tetrahydrocannabinol (THC) in Older Adults


Sponsor

Yale University

Enrollment

20 participants

Start Date

Oct 17, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The overarching goal of this double-blind, placebo-controlled, crossover study is to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) effects of the main analgesic and psychoactive constituent of cannabis, delta-9 tetrahydrocannabinol (THC), among older adults - the fastest growing population of cannabis consumers, and the most likely age cohort to use cannabinoids to relieve pain. This protocol includes two sub-studies, each randomizing 20 men and women aged 65 years or older to receive two administration routes of THC; oral administration and vaporized administration.


Eligibility

Min Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called 2mg Purified THC in an ethanolic solution, a drug called 4mg Purified THC in an ethanolic solution, and others for people with abuse liability, oral vs vaporized thc, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 65 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDronabinol 5 MG

Dronabinol 5 mg

DRUGDronabinol 10 MG

Dronabinol 10mg

DRUG2mg Purified THC in an ethanolic solution

2mg Purified THC in an ethanolic solution

DRUG4mg Purified THC in an ethanolic solution

4mg Purified THC in an ethanolic solution

DRUGPlacebo

Oral placebo and/or vaporized saline


Locations(1)

VA Connecticut Healthcare System

West Haven, Connecticut, United States

View Full Details on ClinicalTrials.gov

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NCT05906511


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