Phase 2
N=31
Enhancing Medication-based Analgesia in Humans- STUDY 2
Pain · Cannabis · Opioid Use
Bottom Line
View on ClinicalTrials.gov: NCT04036968 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Peak Cold Pressor Tolerance — 118.6; 130.8; 161.1; 163.2 minutes — p=0.195
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Within-subject test of blinded study medications (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peak Cold Pressor Tolerance |
118.6; 130.8; 161.1; 163.2; 154.6 | 0.195 |
| PRIMARY Peak Self-report Rating of "Drug Effect" (0-100), as Measured by the Visual Analog Rating Scale |
4.8; 12.6; 15.7; 18.0; 17.9 | <.001 sig |
| PRIMARY Peak Number Accurate on Circular Lights |
64.9; 59.2; 64.1; 63.6; 64.3 | 0.074 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04036968). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.