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

Part of paid clinical trials in West Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT05906511
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Dronabinol 5 MG — DRUG
    Dronabinol 5 mg
  • Dronabinol 10 MG — DRUG
    Dronabinol 10mg
  • 2mg Purified THC in an ethanolic solution — DRUG
    2mg Purified THC in an ethanolic solution
  • 4mg Purified THC in an ethanolic solution — DRUG
    4mg Purified THC in an ethanolic solution
  • Placebo — DRUG
    Oral placebo and/or vaporized saline

Study Details

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.

Key Dates

Start date
Oct 17, 2023
Status verified
Feb 2026
Primary completion
Jun 30, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Active Comparator: Dronabinol 5mg
    Dronabinol 5 mg
  • Placebo Comparator: Dronabinol 10mg
    Dronabinol 10 mg
  • Active Comparator: Vaporized THC 2mg
    Vaporized THC 2mg
  • Active Comparator: Vaporized THC 4mg
    Vaporized THC 4 mg
  • Placebo Comparator: Placebo
    Masked oral placebo or vaporized saline

Primary Outcome Measure

Peak concentration (Cmax) [ Time Frame: Up to 8 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA Connecticut Healthcare SystemWest HavenConnecticut06516
Julia Meyerovich
[email protected]
203-932-5711
Joao P. De Aquino, M.D. (PRINCIPAL_INVESTIGATOR)

Find similar trials in West Haven, CT

By research site
VA Connecticut Healthcare System· West Haven, CT

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