CompletedPhase 2

Enhancing Medication-based Analgesia in Humans

United States29 participantsStarted 2016-12

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 dronabinol (Marinol) would enhance analgesia, subjective reports, and cognitive performance when compared to the FDA-approved opioid hydromorphone (Dilaudid).

Who can participate

Age range18 Years – 75 Years

SexALL

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 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

What they're measuring

Mean Change From Baseline in Seconds to Withdraw Hand From Cold Pressor Laboratory Pain Task

Timeframe: Baseline and time of hand withdrawal from cold pressor, up to 60 seconds

Mean Peak Rating of "Drug Effect" (0-100) as Measured by the Visual Analog Rating Scale

Timeframe: 8-hour study session

Mean Change From Baseline in Maximum Percent Correct on Digit Symbol Substitution Test of Cognitive Behavior

Timeframe: Baseline and 8-hours

Trial details

NCT IDNCT02901275

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-03-23

Results submitted2021-03-30

View on ClinicalTrials.gov More Pain trials