NCT04794205

Acute Changes In Thermal Pain Response Following Single Oral Dose of Beta-Cary

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Hartford Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Beta-Caryophyllene is an essential oil and cannabis plant derivative also found in edible herbs. It has shown promise as a potential analgesic in preclinical trials. However, there are no human studies characterizing pharmacokinetics of BCP in humans. Therefore, it is of great importance to determine the pharmacokinetics of BCP in humans so that appropriate dosing can be developed for analgesia. This pharmacokinetic work will lay the groundwork for subsequent experiments testing the neural mechanism of BCP on pain.

Detailed description

Chronic pain conditions are among the most common reasons adults seek medical care. Given the abuse potential for opioid analgesics, a substantial number of individuals with chronic pain have turned to alternatives such as medical marijuana. There is increasing evidence that medical marijuana has potential benefits for pain related conditions, but it also carries unwanted side effects such as impaired cognition and motor skills that may linger long after use, social stigma, and a moderate potential for abuse. Much of the marijuana/pain research is predicated on the assumption that its potential analgesic effects are due to its primary psychoactive ingredient - delta-9-tetrahydrocannabinol (THC). However, marijuana also contains dozens of phytochemicals, including cannabinoids and terpenes. Accordingly, there is interest in characterizing potential pain-relieving effects of these non-intoxicating constituents of marijuana. Thus far, it is unclear which components may be most relevant for influencing pain, or the mechanisms by which they exert their effects. Betacaryophyllene (BCP) may be a possible candidate because it is isolatable, has shown evidence as a potential analgesic in preclinical research, is known to be safe for human administration, and there is a strong premise for believing it interacts with the neurobiological systems in the brain that process pain. This project was conceptualized to advance our mechanistic understanding of the analgesic potential of BCP in humans. The study will be a randomized, placebo-controlled, double-blind study of the pharmacokinetic mechanisms of BCP, including dosing and duration of action, and its potential analgesic effect on thermal pain induction following single-oral dosage. Ten healthy participants will be screened and on each of four subsequent visits will be dosed with either 5 mg, 30 mg, 150 mg of BCP or placebo. Participants' sensitivity to thermal pain induction will be measured before and after administration of the drug using a self survey of pain level. Successful completion of the project may elucidate the potential analgesic effects of ingesting beta-caryophyllene in humans, which can lead to new forms of treatment for pain.

Conditions

• Beta-Caryophyllene

Interventions

Type	Name	Description
DRUG	Low Dose Beta-Caryophyllene	5 mg BCP
DRUG	Medium Dose Beta-Caryophyllene	30 mg BCP
DRUG	High Dose Beta-Caryophyllene	150 mg BCP
DRUG	Placebo	Placebo drug.

Timeline

• Start date: 2021-09-01
• Primary completion: 2022-04-01
• Completion: 2022-04-01
• First posted: 2021-03-11
• Last updated: 2021-11-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study