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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-29

Study Completion Date

2022-10-15

Brief Summary

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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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Detailed Description

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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.

Conditions

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Cocaine Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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EMB-001 Active

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

Group Type ACTIVE_COMPARATOR

EMB-001

Intervention Type DRUG

720 mg metyrapone/24 mg oxazepam mg BID

EMB-001 Placebo

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

Group Type PLACEBO_COMPARATOR

EMB-001 Placebo

Intervention Type DRUG

Inactive comparator

Interventions

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EMB-001

720 mg metyrapone/24 mg oxazepam mg BID

Intervention Type DRUG

EMB-001 Placebo

Inactive comparator

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No