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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 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. The trial reports 1 study location across 1 state.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05906511
The ClinicalTrials.gov registry entry for NCT05906511 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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