MedTrace Logo

Abuse Potential of Intravenous Remimazolam Compared to Midazolam and Placebo in Recreational CNS Depressant Users

NCT04110535 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2019-10-01

No results posted yet for this study

Summary

A double-blind, randomized crossover study to assess the subjective abuse potential of intravenous remimazolam compared to midazolam and placebo in recreational CNS depressant users

Conditions

  • Abuse, Drug

Interventions

DRUG

Remimazolam

IV administration over 1 minute

DRUG

Midazolam

IV administration over 1 minute

OTHER

Saline

IV administration over 1 minute

Sponsors & Collaborators

  • PRA Health Sciences

    collaborator INDUSTRY

  • Paion UK Ltd.

    lead INDUSTRY

Principal Investigators

  • Shawn Searle, MD · PRA Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2015-06-23
Primary Completion
2015-10-06
Completion
2015-10-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT04110535 on ClinicalTrials.gov