Clinical trial NCT04501874: A Study to Evaluate EMB 001 in Subjects With Cocaine Use Disorder
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine Use Disorder
Keywords: cocaine
Lead sponsor: Embera NeuroTherapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2020-08-06
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Continuous Abstinence from Cocaine Use
timeFrame: Week 11 to Week 13
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
timeFrame: 13 weeks
measure: Reduction in cocaine-use days
timeFrame: Week 2 to Week 13
measure: Urine confirmation of cocaine use
timeFrame: Week 2 to Week 13
measure: Reduction in total Cocaine Craving Questionnaire-Brief score
timeFrame: Week 2 to Week 13
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Pacific Treatment and Research Center, Department of Psychiatry, University of California, San Diego, School of Medicine
state: California
city: Miami
country: United States
facility: Segal Trials
state: Florida
city: Philadelphia
country: United States
facility: U PENN- Perelman School of Medicine
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Embera NeuroTherapeutics, Inc.
name: Bruce McCarthy, MD
role: STUDY_CHAIR
References:
citation: 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.