Phase 2
N=29
Enhancing Medication-based Analgesia in Humans
Pain · Cannabis · Opioid Use, Unspecified
Bottom Line
View on ClinicalTrials.gov: NCT02901275 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcome: Primary: Mean Change From Baseline in Seconds to Withdraw Hand From Cold Pressor Laboratory Pain Task — 25.4; 33.9; 31.7; 36.7 seconds — p=0.61
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
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Seconds to Withdraw Hand From Cold Pressor Laboratory Pain Task |
25.4; 33.9; 31.7; 36.7; 18.1 | 0.61 |
| PRIMARY Mean Peak Rating of "Drug Effect" (0-100) as Measured by the Visual Analog Rating Scale |
10.0; 51.1; 55.7; 55.7; 56.9 | <.0001 sig |
| PRIMARY Mean Change From Baseline in Maximum Percent Correct on Digit Symbol Substitution Test of Cognitive Behavior |
10.2; 5.1; 10.1; 10.3; 3.6 | 0.51 |
Summary
This is a single-group, within-subject, double-blind, double-dummy, placebo and active-controlled study evaluated whether the FDA-approved cannabinoid dronabinol (Marinol) would enhance analgesia, subjective reports, and cognitive performance when compared to the FDA-approved opioid hydromorphone (Dilaudid).
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 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
- Taking medications contraindicated with hydromorphone or dronabinol
- Have a history of clinically significant cardiac arrhythmias or vasopastic disease
- Have an abnormal and clinically-significant ECG
Data sourced from ClinicalTrials.gov (NCT02901275). 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.