Status:
COMPLETED
A Study to Evaluate EMB 001 in Subjects With Cocaine Use Disorder
Lead Sponsor:
Embera NeuroTherapeutics, Inc.
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Cocaine Use Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
EMB-001 is a combination of 2 drugs: the cortisol synthesis inhibitor, metyrapone (Metopirone®), and the benzodiazepine receptor agonist, oxazepam (original trade name Serax®; now marketed as oxazepam...
Detailed Description
This study is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, study to compare the safety and efficacy of EMB-001 with a placebo control in approximately 80 subjects with mode...
Eligibility Criteria
Inclusion
- Key
- Provide written informed consent prior to any study procedures
- 18 to 65 years of age
- DSM-5 diagnosis of moderate-to-severe CUD
- Seeking treatment for CUD. Subjects with past rehabilitation attempts are eligible if the most recent rehabilitation attempt ended at least 30 days prior to Screening
- Female subjects must be of non-childbearing potential
- Male subjects must agree to use accepted contraceptive regimens during the study and for at least 90 days after the last dose of the study drug
- Key
Exclusion
- Any significant current medical conditions
- Known hypersensitivity to or intolerance of oxazepam, metyrapone, or any benzodiazepine, or severe hypersensitivity reaction (e.g., angioedema) to any drug
- Heightened likelihood of having adrenal insufficiency in the investigator's or designees' opinion
- Current court-mandated treatment requirement for a substance-use disorder
- Current DSM-5 moderate-to-severe substance use disorder, other than CUD, tobacco or caffeine
- Current DSM-5 opioid or benzodiazepine use disorder of any severity
Key Trial Info
Start Date :
July 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2022
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT04501874
Start Date
July 29 2020
End Date
October 15 2022
Last Update
August 8 2023
Active Locations (4)
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1
Pacific Treatment and Research Center, Department of Psychiatry, University of California, San Diego, School of Medicine
San Diego, California, United States, 92092
2
Segal Trials
Miami, Florida, United States, 33161
3
U PENN- Perelman School of Medicine
Philadelphia, Pennsylvania, United States, 19104
4
Medical University of South Carolina
Charleston, South Carolina, United States, 29403