Status:
WITHDRAWN
Acute Changes In Thermal Pain Response Following Single Oral Dose of Beta-Cary
Lead Sponsor:
Hartford Hospital
Conditions:
Beta-Caryophyllene
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
PHASE2
Brief 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 studie...
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 t...
Eligibility Criteria
Inclusion
- Males and females of all races and ethnicities.
- 18/50 yrs old.
- Medically healthy (as determined by medical history and treatment).
- No current substance abuse disorder
- Adequate comprehension of English in order to complete study materials.
- Able and willing to provide written informed consent, and willing to commit to the study protocol.
Exclusion
- Estimated premorbid intellectual disability \<80 (WRAT-4)
- Neurological or medical disorder that may affect brain function.
- Comorbid DSM-V diagnosis of alcohol or substance abuse in prior 1 month or substance dependence in prior 3 months
- Vulnerable populations (e.g. pregnant, nursing, incarcerated); unwillingness to use reliable means of contraception.
- High risk for suicide defined as \> 1 attempt in past 12 months that required medical attention, any attempt in the past 3 months or current suicidal ideation with plan and intent such that outpatient care is precluded.
- Current homicidal ideation with plan and intent such that outpatient care is precluded.
- Positive result on urine toxicology test for any substance, including CBD
- Any current acute or chronic pain condition
- Current use of any pain prescribed ROTC medications including opioids, NSAIDs, acetaminophen etc.
- Initial detection of abnormal liver function tests or CBC (see below)
- Initial detection of significant EKG abnormality
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04794205
Start Date
September 1 2021
End Date
April 1 2022
Last Update
November 2 2021
Active Locations (1)
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1
Hartford Hospital
Hartford, Connecticut, United States, 06106