CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 29 enrolled
Drug / intervention
Within-subject test of blinded study medicationsdrug
Likely dose
Not stated in record
Key inclusion· 4
  • Age 18-75 years
  • Negative urine drug screen for illicit substances including cannabis
  • Medically cleared to take study medications
  • Not pregnant or breast feeding
Key exclusion· 9
  • Meets DSM-5 criteria for alcohol or substance use disorder
  • Currently taking opioids for pain
  • Previous adverse reaction to a cannabinoid product
  • Currently prescribed and taking stimulants or benzodiazepines

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02901275
NCT02901275Phase 2Completed

Using Dronabinol to Enhance the Analgesic Effect of Hydromorphone in Humans

Johns Hopkins University·interventional·Posted Sep 15, 2016·Updated Nov 7, 2023

In Brief

A Phase 2 clinical trial evaluating Within-subject test of blinded study medications for Pain and 2 related conditions. Completed, enrolled 29 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 15, 2016
Enrollment StartDec 1, 2016
Primary CompletionMar 23, 2020
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 9.8 years ago

Interventions

Within-subject test of blinded study medicationsdrug

Within-subject double-blind, double-dummy, study design wherein all participants received all doses in 8-hour outpatient sessions. Primary outcomes assessed during 8-hour outpatient sessions and included laboratory pain testing, subjective reports of drug effects, and cognitive performance, evaluated as a function of study medication condition.