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

NCT04794205 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2021-11-02

No results posted yet for this study

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.

Conditions

  • Beta-Caryophyllene

Interventions

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.

Sponsors & Collaborators

  • Hartford Hospital

    lead OTHER

Principal Investigators

  • Godfrey Pearlson, MD · Founding Director Olin Research Center; Yale University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-30
Primary Completion
2022-04-30
Completion
2022-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04794205 on ClinicalTrials.gov