Enhancing Medication-based Analgesia in Humans- STUDY 2 (NCT04036968) | Clinical Trial Compass
CompletedPhase 2
Enhancing Medication-based Analgesia in Humans- STUDY 2
United States31 participantsStarted 2020-02-01
Plain-language 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 analgesia, subjective reports, and cognitive performance when compared to the FDA-approved opioid hydromorphone (Dilaudid). This is study 2 is a series of studies.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Peak Cold Pressor Tolerance
Timeframe: 8 hour study session
2
Peak Self-report Rating of "Drug Effect" (0-100), as Measured by the Visual Analog Rating Scale