Cocaine Use Disorder
Conditions
Keywords
cocaine
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.
Interventions
DRUGEMB-001
720 mg metyrapone/24 mg oxazepam mg BID
DRUGEMB-001 Placebo
Inactive comparator
Sponsors
National Institute on Drug Abuse (NIDA)
Embera NeuroTherapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Continuous Abstinence from Cocaine Use | 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) | 13 weeks | Adverse event data (including clinically significant changes in laboratory values) will be compiled for EMB-001 and placebo cohorts. |
| Reduction in cocaine-use days | Week 2 to Week 13 | Self-report weekly cocaine non-use days by Timeline Follow-Back |
| Urine confirmation of cocaine use | Week 2 to Week 13 | Qualitative urine BE levels twice per week |
| Reduction in total Cocaine Craving Questionnaire-Brief score | 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). |
Countries
United States
Outcome results
None listed