CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 31 enrolled
Drug / intervention
Within-subject test of blinded study medicationsdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT04036968
NCT04036968Phase 2Completed
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Evaluating Cannabidiol (CBD) to Enhance the Analgesic Effect of Hydromorphone in Humans

Johns Hopkins University·interventional·Posted Jul 30, 2019·Updated Dec 19, 2023

In Brief

A Phase 2 clinical trial evaluating Within-subject test of blinded study medications for Pain and 2 related conditions. Completed, enrolled 31 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 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain, Cannabis, Opioid Use
CountriesUnited States
CollaboratorsNational Institute on Drug Abuse (NIDA)

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedJul 30, 2019
Enrollment StartFeb 1, 2020
Primary CompletionNov 1, 2022
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 6.9 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.