PK/PD of Oral and Vaporized Delta-9-Tetrahydrocannabinol (THC) in Older Adults
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age65+
SponsorYale University
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
Healthy male and female participants aged 65 ≥ years old
Prior exposure to THC or cannabis least once in the last 10 years; 1-10 times in the last 20 years; or more than 20 times in their lifetime
Capable of providing informed consent in English.
Disqualifiers
Meeting DSM-5 criteria for psychiatric/substance use disorders (SUD) other than tobacco use disorder, within the last year
Current use of cannabinoid products, as evidenced by a urine drug screen
Having a history of treatment for cannabis use disorder
History of intent or current intent of abstaining from cannabis use
Trial design
Design model
Crossover
Treatments tested in this trial
Dronabinol 5 MG
DrugDronabinol 5 mg
Dronabinol 10 MG
DrugDronabinol 10mg
2mg Purified THC in an ethanolic solution
Drug2mg Purified THC in an ethanolic solution
4mg Purified THC in an ethanolic solution
Drug4mg Purified THC in an ethanolic solution
Placebo
DrugOral placebo and/or vaporized saline
Treatment groups
20 Participants
are divided into 5 treatment groupsGroup A: Dronabinol 5mgActive comparator 1 intervention
Group B: Dronabinol 10mgPlacebo comparator 1 intervention
Group C: Vaporized THC 2mgActive comparator 1 intervention
Group D: Vaporized THC 4mgActive comparator 1 intervention
Group E: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Peak concentration (Cmax)
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.
Time frame
Up to 8 hours2
Time to attain Cmax concentration (Tmax)
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 time to attain Cmax concentration (Tmax) will be derived using a linear noncompartmental analysis.
Time frame
Up to 8 hours3
Area under the plasma concentration-time curve (AUC0-8h)
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 area under the plasma concentration-time curve (AUC0-8h) will be derived using a linear noncompartmental analysis.
Time frame
Up to 8 hours4
Nociception
Multimodal quantitative sensory testing (QST) will be used ensure that various types of afferent fibers are engaged, so that the analgesic efficacy of THC can be comprehensively investigated. A composite pain sensitivity measure as a Z-score (ranging from -1 to +1) will be derived from the QST battery, with greater scores indicating a higher sensitivity to pain.
Time frame
Up to 8 hoursSponsors and contacts
Click on the lead sponsor to view all of their trials.
Yale University
Lead sponsor
VA Connecticut Healthcare System
Collaborator
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov