Cocaine Use DisorderPhase 2NCT04501874
A Study to Evaluate EMB 001 in Subjects With Cocaine Use Disorder
A Phase 2 study testing EMB-001 in people with Cocaine Use Disorder, run by Embera NeuroTherapeutics, Inc. at 4 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cocaine Use Disorder
- What is being tested?
- EMB-001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 4 sitesUnited States
- Study dates
- 29 Jul 2020to 15 Oct 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Medical University of South Carolina
Charleston, South Carolina, 29403
Segal Trials
Miami, Florida, 33161
U PENN- Perelman School of Medicine
Philadelphia, Pennsylvania, 19104
Pacific Treatment and Research Center, Department of Psychiatry, University of California, San Diego, School of Medicine
San Diego, California, 92092
About this study
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
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).
Read the 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.
- Conditions
- Cocaine Use Disorder
- Being tested
- EMB-001, EMB-001 Placebo
- Keywords
- cocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMB-001Drug
720 mg metyrapone/24 mg oxazepam mg BID
EMB-001 PlaceboDrug
Inactive comparator
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: EMB-001 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Week 11 to Week 13
Secondary outcomes (2)
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)
Measured: 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).
Measured: Baseline to Week 13 (Day 91)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start29 Jul 2020
- Primary completion27 Jul 2022
- Study completion15 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cocaine Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Embera NeuroTherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Bruce McCarthy, MD, Study chair, Embera NeuroTherapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04501874
- Sponsor's protocol ID
- ERL-003
- Other IDs
- 5U01DA038879-03
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2020
- Last updated
- 21 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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).
Publications
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.
PubMed 22236504
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04501874
- Acronym / sponsor ID
- ERL-003
- Conditions
- Cocaine Use Disorder
- Keywords
- cocaine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Embera NeuroTherapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 29 Jul 2020 (actual)
- Primary completion
- 27 Jul 2022 (actual)
- Study completion
- 15 Oct 2022 (actual)
- First posted
- 6 Aug 2020 (actual)
- Results
- Posted 21 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMB-001 Active | Active comparator | Drug: EMB-001EMB-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 |
| EMB-001 Placebo | Placebo comparator | Drug: EMB-001 PlaceboEMB-001 Placebo by mouth twice per day for 12 weeks followed by a 1 week taper |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMB-001720 mg metyrapone/24 mg oxazepam mg BID | Drug | EMB-001 Active |
| EMB-001 PlaceboInactive comparator | Drug | EMB-001 Placebo |
Primary outcome
Continuous Abstinence From Cocaine Use
Time frame: Week 11 to Week 13
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)
2 secondary outcomes
Change in Cocaine-use Days (Weekly Average)
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
Time frame: Baseline to Week 13 (Day 91)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22236504Kablinger 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.
- Individual participant dataSharing planned: 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce McCarthy, MD study chair
Embera NeuroTherapeutics, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EMB-001 in people with Cocaine Use Disorder, run by Embera NeuroTherapeutics, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continuous Abstinence From Cocaine Use (time frame: Week 11 to Week 13). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04501874, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.