A Phase 2 interventional study of EMB-001 and EMB-001 Placebo in Cocaine Use Disorder, sponsored by Embera NeuroTherapeutics, Inc.. Completed at 4 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Embera NeuroTherapeutics, Inc. · Phase 2, Interventional, and Treatment
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).
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:
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.
Embera NeuroTherapeutics, Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 by mouth twice per day for 12 weeks followed by a 1 week taper
Drug: EMB-001 Placebo
720 mg metyrapone/24 mg oxazepam mg BID
Inactive comparator
Continuous Abstinence From Cocaine Use
The Primary Endpoint is the Percentage 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)
Time frame: Week 11 to Week 13
Change in Cocaine-use Days (Weekly Average)
Weekly cocaine use days 28 days prior to Screening (Time Line Follow-back (TLFB) only) to weekly use days during final 3 weeks of treatment (TLFB confirmed by urine BE)
Time frame: Final 3 weeks of treatment (Weeks 11, 12 and 13 for subjects who complete the trial fully, but whichever weeks are the final 3 weeks for subjects who do not fully complete the trial) compared to the 28 days prior to screening.
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).
Time frame: Baseline to Week 13 (Day 91)
| Milestone | EMB-001 Active | EMB-001 Placebo |
|---|---|---|
| Started | 41 | 41 |
| Completed | 18 | 19 |
| Not completed | 23 | 22 |
The Primary Endpoint is the Percentage 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)
| Participants | EMB-001 Active | EMB-001 Placebo |
|---|---|---|
| Continuous Abstinence From Cocaine Use | 2 | 0 |
Weekly cocaine use days 28 days prior to Screening (Time Line Follow-back (TLFB) only) to weekly use days during final 3 weeks of treatment (TLFB confirmed by urine BE)
| Weekly cocaine use days | EMB-001 Active | EMB-001 Placebo |
|---|---|---|
| Change in Cocaine-use Days (Weekly Average) | 0.6 ± 2.5 | 1.2 ± 1.6 |
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).
| CCQ-B score | EMB-001 Active | EMB-001 Placebo |
|---|---|---|
| Reduction in Total Cocaine Craving Questionnaire-Brief Score | -1.62 ± 2.0 | -2.63 ± 1.3 |
Collected over From randomization to follow-up visit (up to 18 weeks). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| EMB-001 Active | 0/41 (0%) | 0/41 (0%) | 21/41 (51.2%) |
| EMB-001 Placebo | 0/41 (0%) | 0/41 (0%) | 25/41 (61%) |
| Event | EMB-001 Active | EMB-001 Placebo |
|---|---|---|
| SomnolenceNervous system disorders | 8/41 | 6/41 |
| HeadacheNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 4/41 | 6/41 |
| DiarrheaGastrointestinal disorders | 3/41 | 5/41 |
| ACTH stimulation test abnormalInvestigations | 4/41 | 0/41 |
| FatigueGeneral disorders | 3/41 | 4/41 |
| Increased appetiteMetabolism and nutrition disorders | 3/41 | 1/41 |
| Decreased appetiteMetabolism and nutrition disorders | 2/41 | 3/41 |
| Age, Continuous(Years) | EMB-001 Active | EMB-001 Placebo | Total |
|---|---|---|---|
| Mean | 50.6 ± 9.2 | 52.0 ± 7.5 | 51.3 ± 8.38 |
| Sex: Female, Male(Participants) | EMB-001 Active | EMB-001 Placebo | Total |
|---|---|---|---|
| Female | 4 | 3 | 7 |
| Male | 37 | 38 | 75 |
| Race (NIH/OMB)(Participants) | EMB-001 Active | EMB-001 Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 0 | 2 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 32 | 31 | 63 |
| White | 7 | 10 | 17 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Severity of cocaine use disorder (DSM-V)(Participants) | EMB-001 Active | EMB-001 Placebo | Total |
|---|---|---|---|
| Moderate | 7 | 2 | 9 |
| Severe | 34 | 39 | 73 |
| Number of days of cocaine use in the 28 days prior to Screening(Days) | EMB-001 Active | EMB-001 Placebo | Total |
|---|---|---|---|
| Mean | 20.1 ± 6.1 | 21.8 ± 6.5 | 20.9 ± 6.3 |
| Cocaine use route of administration prior to Screening(Participants) | EMB-001 Active | EMB-001 Placebo | Total |
|---|---|---|---|
| Nasal | 14 | 14 | 28 |
| Nasal, Smoking | 9 | 9 | 18 |
| Oral | 1 | 0 | 1 |
| Other: inhale | 1 | 0 | 1 |
| Other: nasal and smoking | 1 | 1 | 2 |
| Smoking | 15 | 17 | 32 |
| CCQ-B Score(Score) | EMB-001 Active | EMB-001 Placebo | Total |
|---|---|---|---|
| Mean | 3.7 ± 1.7 | 4.1 ± 1.3 | 3.9 ± 1.5 |
| ACE Summary(Scores on scale) | EMB-001 Active | EMB-001 Placebo | Total |
|---|---|---|---|
| Mean | 1.8 ± 1.9 | 1.6 ± 2.0 | 1.7 ± 2.0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Every three months, the NIDA DSMB will convene to review the overall safety data, as well as data on safety summarized by treatment condition. As per NIH guidelines, the objective of these reviews will be to determine whether continued conduct of the trial poses any undue risk for participants. Blinded data tables, figures and/or listings will be provided to the Data Safety Monitoring Board (DSMB).
Supporting information: Study protocol, Clinical study report
Time frame: Every three months- blinded results
Access criteria: A DSMB report is prepared an submitted via NIDA
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: EMB-001
Embera NeuroTherapeutics, Inc.