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

NCT04501874 | Completed Phase 2 DMC FDA Drug

• 2 other identifiers: ERL-0035U01DA038879-03
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 4

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).

Conditions

Cocaine Use Disorder

Keywords

cocaine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

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

  13 weeks

• Reduction in cocaine-use days

  Week 2 to Week 13

• Urine confirmation of cocaine use

  Week 2 to Week 13

• Reduction in total Cocaine Craving Questionnaire-Brief score

  Week 2 to Week 13

Study Arms (2)

EMB-001 Active

ACTIVE COMPARATOR

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

Drug: EMB-001

EMB-001 Placebo

PLACEBO COMPARATOR

EMB-001 Placebo by mouth twice per day for 12 weeks followed by a 1 week taper

Drug: EMB-001 Placebo

Interventions

EMB-001 DRUG

720 mg metyrapone/24 mg oxazepam mg BID

EMB-001 Active

EMB-001 Placebo DRUG

Inactive comparator

EMB-001 Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Female subjects must be of non-childbearing potential.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide written informed consent prior to any study procedures
• 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 may not qualify 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

Sponsors & Collaborators

• Embera NeuroTherapeutics, Inc.: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (4)

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

San Diego, California, 92092, United States

Location

Segal Trials

Miami, Florida, 33161, United States

Location

U PENN- Perelman School of Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29403, United States

Location

Related 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.

  PMID: 22236504 BACKGROUND

Study Officials

• Bruce McCarthy, MD

  Embera NeuroTherapeutics, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2020
• First Posted: August 6, 2020
• Study Start: July 29, 2020
• Primary Completion: July 27, 2022
• Study Completion: October 15, 2022
• Last Updated: August 8, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Every three months- blinded results
• Access Criteria: A DSMB report is prepared an submitted via NIDA

Locations

US (4)