Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Dronabinol · 1 trial · 3 indications
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.
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.
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.
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.
A modified Multiple-Choice Procedure (MPC) will be used to measure abuse liability. The MCP was developed and validated by Roland Griffiths to efficiently assess drug reinforcement - including cannabinoid-induced reinforcement. In each of the 6 experimental sessions, participants will choose between forfeiting or receiving escalating sums of money, on a scale of values between -$20.00 and $20.00; or re-receiving the study medication assigned for that day. The primary outcome will be the crossover point, the value at which the participant chooses money rather than the study medication, which will be determined for each session.
| Arm | Type | Description |
|---|---|---|
| Dronabinol 5mg | ACTIVE_COMPARATOR | Dronabinol 5 mg |
| Dronabinol 10mg | PLACEBO_COMPARATOR | Dronabinol 10 mg |
| Vaporized THC 2mg | ACTIVE_COMPARATOR | Vaporized THC 2mg |
| Vaporized THC 4mg | ACTIVE_COMPARATOR | Vaporized THC 4 mg |
| Placebo | PLACEBO_COMPARATOR | Masked oral placebo or vaporized saline |
| Name | Type | Description |
|---|---|---|
| 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 |
Inclusion Criteria: 1. Healthy male and female participants aged 65 ≥ years old 2. 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 3. Capable of providing informed consent in English. Exclusion Criteria: 1...
Dronabinol is a small molecule being developed for pain and tolerance. It is currently in Phase 1 clinical development as an investigational drug. The active clinical trial is studying its effects in older adults, focusing on pain management and tolerance, among other outcomes.
Dronabinol is a synthetic form of delta-9-tetrahydrocannabinol (THC), the primary psychoactive component of cannabis. It works by binding to cannabinoid receptors in the body, which are part of the endocannabinoid system, to modulate pain signaling and other physiological processes.
Dronabinol is being developed by National Healthcare Corp., a company traded under the ticker symbol NHC. The company is conducting clinical research to evaluate the drug's safety and efficacy for pain and tolerance indications.
Dronabinol is in Phase 1 clinical development. The current trial is an early Phase 1 study that is actively recruiting participants. As an investigational drug, it has not yet been approved by regulatory authorities and is still undergoing clinical evaluation.
Dronabinol is being studied in a single clinical trial with the identifier NCT05906511. This early Phase 1 study, titled 'PK/PD of Oral and Vaporized Delta-9-Tetrahydrocannabinol (THC) in Older Adults,' is recruiting 20 participants aged 65 and older in the United States. The trial is randomized, double-blind, and placebo-controlled.
Yes, Dronabinol is also known as Dronabinol 5 MG. This alternative name refers to a specific dosage strength of the drug, which is commonly used in clinical and pharmaceutical contexts. Both names refer to the same active pharmaceutical ingredient.