A Phase 1 interventional study of EMB-001 and Placebo in Cocaine Use Disorder, sponsored by Embera NeuroTherapeutics, Inc.. Completed at 1 site in United States. Open to participants aged 21 Years to 55 Years. Per ClinicalTrials.gov, last updated 2017-08-01.
Sponsored by Embera NeuroTherapeutics, Inc. · Phase 1, 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 Phase 1b cocaine interaction study is being conducted in order to assess the safety and PK of EMB-001 and cocaine in combination.
This is a single center, randomized, double-blinded, multiple-dose, PLB controlled, 2-period, 4-sequence, crossover study design.
After establishing eligibility approximately 16 subjects with cocaine use disorder will be randomized to one of four sequences.
Treatment periods will be separated by a 7-day in-patient washout period. EMB-001/PLB will be orally administered for 7 consecutive days, BID for 6 days (starting on Day 1 and Day 15) followed on the last day (Day 7 and Day 21) by one EMB-001/PLB oral dose in the morning. Infusion of 40 mg IV cocaine and IV saline-to-match cocaine infusion will be administered in a randomized order, 2 hours apart, starting 3 hours after the last morning EMB-001/PLB oral administration.
The subjects will be discharged from the research clinic 2 days after the last dose of cocaine, and will have a follow-up visit 7 days after last dose.
Exclusion Criteria:
EMB-001 will be orally administered for 7 consecutive days, twice daily for 6 days followed on the last day by one EMB-001 oral dose (QD) in the morning. Three hours later Cocaine IV or Saline IV will be administered followed 2 hours by the other (saline or cocaine).
Drug: EMB-001 · Drug: Cocaine IV · Drug: Saline IV
PLB-to-match EMB-001 will be orally administered for 7 consecutive days, BID for 6 days, followed on the last day by one PLB oral dose in the morning. Three hours later Cocaine IV or Saline IV will be administered followed 2 hours by the other (saline or cocaine).
Drug: Placebo · Drug: Cocaine IV · Drug: Saline IV
EMB-001 is a combination of metyrapone (720mg per dose in this study) and oxazepam (24mg per dose in this study)
Also known as: metyrapone and oxazepam
EMB-001 matched placebo
Also known as: oral placebo
Cocaine administered at doses of 20 and 40mg
Also known as: IV cocaine
Cocaine matched placebo
Also known as: IV saline
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Adverse event data (including clinically significant changes in laboratory values) will be compiled for EMB-001 and placebo cohorts.
Time frame: 29 Days
Vital signs
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.
Time frame: 29 days
ECGs
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.
Time frame: 29 days
PK Parameter EMB-001
Cmax (maximum concentration) of EMB-001 will be compared when taken alone and when taken with cocaine
Time frame: 21 days
PK Parameter Cocaine
Cmax (maximum concentration) of cocaine will be compared when taken alone and when taken with EMB-001
Time frame: 21 days
PK Parameter EMB-001
AUC (area under the curve) of EMB-001 will be compared when taken alone and when taken with cocaine
Time frame: 21 days
PK Parameter Cocaine
AUC (area under the curve) of Cocaine will be compared when taken alone and when taken with EMB-001
Time frame: 21 days
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, Csr
This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Embera NeuroTherapeutics, Inc.