Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05906511 · ClinicalTrials.gov registry record · Early Phase 1
PK/PD of Oral and Vaporized Delta-9-Tetrahydrocannabinol (THC) in Older Adults
A Early Phase 1 study of Pain, Tolerance and Oral vs Vaporized THC, sponsored by Yale University.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT05906511: Recruiting Early Phase 1 study of Pain, Tolerance and Oral vs Vaporized THC, sponsored by Yale University.
NCT05906511 is a Early Phase 1 study of Pain, Tolerance and Oral vs Vaporized THC that is actively recruiting participants, run by Yale University. The registered enrollment target is 20 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (62% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05906511, a Early Phase 1 study of Pain, Tolerance and Oral vs Vaporized THC, is actively recruiting participants, sponsored by Yale University.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Serial blood samples will be collected for plasma levels of THC; its phase I metabolite 11-hydroxy-THC (OH-THC); phase II metabolite 11-nor-9-carboxy-THC (THC-COOH); and THC-COOH glucuronide. For THC and all other analytes, the peak concentration (Cmax) will be derived using a linear noncompartmental analysis.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Dronabinol 5 MG
- DRUG Dronabinol 10 MG
- DRUG 2mg Purified THC in an ethanolic solution
- DRUG 4mg Purified THC in an ethanolic solution
Study Locations (1)
Connecticut
- VA Connecticut Healthcare System - West Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2023-10-17 |
| Est. Completion | 2026-08-31 |
| Phase | Early Phase 1 |
What NCT05906511 shows while recruiting
NCT05906511 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (62% lower).
The record links to 3 conditions, with Pain, Tolerance appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.
NCT05906511 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT05906511 about?
NCT05906511 is a clinical study titled "PK/PD of Oral and Vaporized Delta-9-Tetrahydrocannabinol (THC) in Older Adults". 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 pop...
What is the current status of trial NCT05906511?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 20 participants. The study started on 2023-10-17. Estimated completion is 2026-08-31.
What conditions does trial NCT05906511 study?
This clinical trial studies the following conditions: Pain, Tolerance, Oral vs Vaporized THC, Abuse Liability.
What interventions are being tested in trial NCT05906511?
The interventions under investigation include: Placebo (DRUG), Dronabinol 5 MG (DRUG), Dronabinol 10 MG (DRUG), 2mg Purified THC in an ethanolic solution (DRUG), 4mg Purified THC in an ethanolic solution (DRUG).
Who is sponsoring clinical trial NCT05906511?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05906511 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05906511's enrollment target sits among peer trials
20 1157th of 2000 higher than 710 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00573339 · 20 participants
Cardiac Magnetic Resonance Imaging (MRI) Normal Reference Control Group Testing
- NCT00692939 · 20 participants · Phase 1
Autologous Stem Cell Transplantation for Crohn's Disease
- NCT00967785 · 20 participants · Phase 1
A Phase I Study of Mozobil in the Treatment of Patients With WHIMS
- NCT01406691 · 20 participants · Phase 4
Light Flashes to Treat Delayed Sleep Phase Disorder (DSPD)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI