Status:
COMPLETED
Enhancing Medication-based Analgesia in Humans- STUDY 2
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Pain
Cannabis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This is a single-group, within-subject, double-blind, double-dummy, placebo and active-controlled study evaluated whether the FDA-approved cannabinoid cannabidiol (CBD; Epidiolex) would enhance analge...
Detailed Description
This was a human laboratory systematic examination of whether adding the FDA-approved cannabinoid cannabidiol (CBD; Epidiolex; oral) to the FDA-approved opioid hydromorphone (Dilaudid; oral) would cha...
Eligibility Criteria
Inclusion
- Aged 18-75
- Urine sample tests negative for common illicit substances of abuse, including cannabis
- Medically cleared to take study medications
- Are not pregnant or breast feeding
- Willing to comply with the study protocol.
Exclusion
- Meet DSM-5 criteria for alcohol/substance use disorder
- Taking opioids for pain
- Previous adverse reaction to a cannabinoid product
- Prescribed and taking stimulants or benzodiazepines
- Answer "yes" to item 1 of the Brief Pain Inventory indicating chronic pain
- Self-report any illicit drug or cannabinoid use in the past 7 days
- Presence of any clinically significant medical/psychiatric illness judged by the investigators to put subject at elevated risk for experiencing an adverse event
- History of seizure disorder
- Have a known allergy to the study medications or sesame seed oil
- ALT or AST levels \>3x ULN and/or Bilirubin levels \>2x ULN during Screening
- Current (past 60-day) suicidal thoughts or past year history of suicidal behavior
- Taking medications contraindicated with hydromorphone or cannabidiol
- Have a history of clinically significant cardiac arrhythmias or vasopastic disease
- Have an abnormal and clinically-significant ECG
Key Trial Info
Start Date :
February 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2022
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT04036968
Start Date
February 1 2020
End Date
November 1 2022
Last Update
December 19 2023
Active Locations (1)
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1
Johns Hopkins University Bayview Medical Campus
Baltimore, Maryland, United States, 21224