Trial · NCT02856854
A Study of Metyrapone and Oxazepam Combination Product (EMB-001) and Cocaine
NCT02856854, Phase 1, Completed, Embera NeuroTherapeutics, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Metyrapone and Oxazepam Combination Product (EMB-001) and Cocaine. Trials, record NCT02856854. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02856854
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Metyrapone and Oxazepam Combination Product (EMB-001) and Cocaine
- NCT number
- NCT02856854
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 18 participants, actual
- Lead sponsor
- Embera NeuroTherapeutics, Inc.
- Conditions
- Cocaine Use Disorder
- Interventions
- EMB-001, Placebo, Cocaine IV, Saline IV
- First posted
- 2016-08-05
- Last updated
- 2017-08-01
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) | 29 Days | Adverse event data (including clinically significant changes in laboratory values) will be compiled for EMB-001 and placebo cohorts. |
| Primary | Vital signs | 29 days | Blood Pressure (BP) and heart rate (HR) measures during saline infusions will be compared to HR and BP after cocaine infusion (40 mg). Changes in BP and HR induced by cocaine infusion along with EMB-001 will be compared to those with EMB-001-matched placebo. |
| Primary | ECGs | 29 days | Changes in ECG readings during saline infusion will be compared to those taken during cocaine infusion along with EMB-001 will be compared to those with EMB-001-matched placebo. |
| Secondary | PK Parameter EMB-001 | 21 days | Cmax (maximum concentration) of EMB-001 will be compared when taken alone and when taken with cocaine |
| Secondary | PK Parameter Cocaine | 21 days | Cmax (maximum concentration) of cocaine will be compared when taken alone and when taken with EMB-001 |
| Secondary | PK Parameter EMB-001 | 21 days | AUC (area under the curve) of EMB-001 will be compared when taken alone and when taken with cocaine |
| Secondary | PK Parameter Cocaine | 21 days | AUC (area under the curve) of Cocaine will be compared when taken alone and when taken with EMB-001 |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22236504 | BACKGROUND |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01DA038879 | EMB-001: A novel combination therapy for the treatment of cocaine-use disorder | MCCARTHY, BRUCE | EMBERA NEUROTHERAPEUTICS, INC. | NATIONAL INSTITUTE ON DRUG ABUSE | 2016 to 2019 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02856854
GET https://conductscience.org/api/trials/v1/NCT02856854/registered