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Completed

NCT Number: NCT04501874

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

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).

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Key information

Conditions

Cocaine Use Disorder

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pacific Treatment and Research Center, Department of Psychiatry, University of California, San Diego, School of Medicine, San Diego, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EMB-001

Drug

720 mg metyrapone/24 mg oxazepam mg BID

EMB-001 Placebo

Drug

Inactive comparator

Primary outcomes

  1. Continuous Abstinence from Cocaine Use

    Time frame: 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 outcomes

  1. Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

    Time frame: 13 weeks

    Adverse event data (including clinically significant changes in laboratory values) will be compiled for EMB-001 and placebo cohorts.

  2. Reduction in cocaine-use days

    Time frame: Week 2 to Week 13

    Self-report weekly cocaine non-use days by Timeline Follow-Back

  3. Urine confirmation of cocaine use

    Time frame: Week 2 to Week 13

    Qualitative urine BE levels twice per week

  4. Reduction in total Cocaine Craving Questionnaire-Brief score

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Embera NeuroTherapeutics, Inc.

Industry

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 6, 2020
Registry last updated
Aug 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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