A Study to Evaluate EMB 001 in Subjects With Cocaine Use Disorder
- Registration Number
- NCT04501874
- Lead Sponsor
- Embera NeuroTherapeutics, Inc.
- 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 (generic) only).
This is a Phase 2 study in approximately 80 adult subjects with moderate-to-severe Cocaine Use Disorder (CUD).
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 82
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EMB-001 Placebo EMB-001 Placebo EMB-001 Placebo by mouth twice per day for 12 weeks followed by a 1 week taper EMB-001 Active EMB-001 EMB-001 Combination product of 720 mg metyrapone/24 mg oxazepam mg by mouth twice per day for 12 weeks followed by a 1 week taper
- Primary Outcome Measures
Name Time Method Continuous Abstinence from Cocaine Use Week 11 to Week 13 The Primary Endpoint is the Proportion of Subjects That Successfully Achieve Abstinence From Cocaine During the Last Three Weeks of Treatment using the Timeline Follow Back; days of abstinence, confirmed by Urine benzoylecgonine (BE)
- Secondary Outcome Measures
Name Time Method Urine confirmation of cocaine use Week 2 to Week 13 Qualitative urine BE levels twice per week
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) 13 weeks Adverse event data (including clinically significant changes in laboratory values) will be compiled for EMB-001 and placebo cohorts.
Reduction in cocaine-use days Week 2 to Week 13 Self-report weekly cocaine non-use days by Timeline Follow-Back
Reduction in total Cocaine Craving Questionnaire-Brief score Week 2 to Week 13 The Cocaine Craving Questionnaire-Brief (CCQ-B) assesses current cocaine craving in routine clinical practice. The CCQ-B is a 10 item questionnaire and items are scored on a one to seven scale. Total responses are then divided by 10 to achieve a total craving score between 1.0 (least craving) to 7.0 (most craving).
Trial Locations
- Locations (4)
Pacific Treatment and Research Center, Department of Psychiatry, University of California, San Diego, School of Medicine
🇺🇸San Diego, California, United States
Segal Trials
🇺🇸Miami, Florida, United States
U PENN- Perelman School of Medicine
🇺🇸Philadelphia, Pennsylvania, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States