A Study to Evaluate EMB 001 in Subjects With Cocaine Use Disorder
a study on Cocaine Use
Summary
- Eligibility
- for people ages 18-65 (full criteria)
- Location
- at San Diego, California and other locations
- Dates
- study startedestimated completion
Description
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 (generic) only). This is a Phase 2 study in approximately 80 adult subjects with moderate-to-severe Cocaine Use Disorder (CUD).
Official Title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Study to Evaluate the Safety and Efficacy of EMB 001 in Subjects With Moderate-to-Severe Cocaine Use Disorder
Details
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 moderate-to-severe CUD. Subjects will receive investigational medicinal product (IMP) during a 12-week, double-blind Treatment Period (Week 2 through Week 13) and a 1-week, double-blind Taper Period (Week 14). After undergoing study procedures during the Screening and Baseline Periods, subjects who meet inclusion and exclusion criteria will then be randomized in a 1:1 ratio (n=40/arm) to one of the following for the Treatment Period (weeks 2 - 13) on Study Day 8: - EMB-001 720 mg metyrapone/24 mg oxazepam mg BID, for a total daily dose of 1440 mg metyrapone and 48 mg oxazepam (Active Group) - Placebo BID, (Placebo Group) During the Taper Period (week 14), subjects in the Active Group will receive EMB-001 240/8 mg BID; and the Placebo Group will continue to receive placebo. Both groups will change from taking three capsules BID (twice daily) to one capsule BID (twice daily). There will be a follow-up visit for safety assessments at Week 18.
Keywords
Cocaine Use Disorder cocaine Disease EMB-001
Eligibility
You can join if…
Open to people ages 18-65
- 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
You CAN'T join if...
- 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
Locations
- Pacific Treatment and Research Center, Department of Psychiatry, University of California, San Diego, School of Medicine
not yet accepting patients
San Diego California 92092 United States - Medical University of South Carolina
accepting new patients
Charleston South Carolina 29403 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Embera NeuroTherapeutics, Inc.
- ID
- NCT04501874
- Phase
- Phase 2
- Study Type
- Interventional
- Last Updated