A Study to Evaluate EMB 001 in Subjects With Cocaine Use Disorder

Embera NeuroTherapeutics, Inc.82 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Cocaine Use Disorder

Interventions

EMB-001DRUG

720 mg metyrapone/24 mg oxazepam mg BID

EMB-001 PlaceboDRUG

Inactive comparator

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * 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 Criteria: * 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 (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

Outcomes

Primary Outcomes

Continuous Abstinence From Cocaine Use

The Primary Endpoint is the Percentage 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)

Time frame: Week 11 to Week 13

Secondary Outcomes

Change in Cocaine-use Days (Weekly Average)

Weekly cocaine use days 28 days prior to Screening (Time Line Follow-back (TLFB) only) to weekly use days during final 3 weeks of treatment (TLFB confirmed by urine BE)

Time frame: Final 3 weeks of treatment (Weeks 11, 12 and 13 for subjects who complete the trial fully, but whichever weeks are the final 3 weeks for subjects who do not fully complete the trial) compared to the 28 days prior to screening.

Reduction in Total Cocaine Craving Questionnaire-Brief Score

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).

Time frame: Baseline to Week 13 (Day 91)

Data from ClinicalTrials.gov

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