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Enhancing Medication-based Analgesia in Humans- STUDY 2

NCT04036968 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2023-12-19

Study results available
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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.

Conditions

  • Pain
  • Cannabis
  • Opioid Use

Interventions

DRUG

Within-subject test of blinded study medications

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.

Sponsors & Collaborators

Principal Investigators

  • Kelly E Dunn, PhD · Johns Hopkins University

  • Claudia Campbell, PhD · Johns Hopkins University

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-01
Primary Completion
2022-11-01
Completion
2022-11-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04036968 on ClinicalTrials.gov