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

Cocaine Use Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04501874
• Other study ID #: ERL-003
• Secondary ID: 5U01DA038879-03
• Status: Completed
• Phase: Phase 2
• Start date: July 29, 2020
• Est. completion date: October 15, 2022

Study information

• Verified date: August 2023
• Source: Embera NeuroTherapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: October 15, 2022
• Est. primary completion date: July 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cocaine Use Disorder

Intervention

Drug:
• EMB-001
720 mg metyrapone/24 mg oxazepam mg BID
• EMB-001 Placebo
Inactive comparator

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Segal Trials	Miami	Florida
United States	U PENN- Perelman School of Medicine	Philadelphia	Pennsylvania
United States	Pacific Treatment and Research Center, Department of Psychiatry, University of California, San Diego, School of Medicine	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Embera NeuroTherapeutics, Inc.	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kablinger AS, Lindner MA, Casso S, Hefti F, DeMuth G, Fox BS, McNair LA, McCarthy BG, Goeders NE. Effects of the combination of metyrapone and oxazepam on cocaine craving and cocaine taking: a double-blind, randomized, placebo-controlled pilot study. J Psychopharmacol. 2012 Jul;26(7):973-81. doi: 10.1177/0269881111430745. Epub 2012 Jan 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Continuous Abstinence from Cocaine Use	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)	Week 11 to Week 13
Secondary	Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)	Adverse event data (including clinically significant changes in laboratory values) will be compiled for EMB-001 and placebo cohorts.	13 weeks
Secondary	Reduction in cocaine-use days	Self-report weekly cocaine non-use days by Timeline Follow-Back	Week 2 to Week 13
Secondary	Urine confirmation of cocaine use	Qualitative urine BE levels twice per week	Week 2 to Week 13
Secondary	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).	Week 2 to Week 13