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

NCT05906511 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-02-23

No results posted yet for this study

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.

Conditions

  • Pain, Tolerance
  • Oral vs Vaporized THC
  • Abuse Liability

Interventions

DRUG

Dronabinol 5 MG

Dronabinol 5 mg

DRUG

Dronabinol 10 MG

Dronabinol 10mg

DRUG

2mg Purified THC in an ethanolic solution

2mg Purified THC in an ethanolic solution

DRUG

4mg Purified THC in an ethanolic solution

4mg Purified THC in an ethanolic solution

DRUG

Placebo

Oral placebo and/or vaporized saline

Sponsors & Collaborators

  • VA Connecticut Healthcare System

    collaborator FED

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Yale University

    lead OTHER

Principal Investigators

  • Joao P. De Aquino, M.D. · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-17
Primary Completion
2026-06-30
Completion
2026-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05906511 on ClinicalTrials.gov