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A Study of Metyrapone and Oxazepam Combination Product (EMB-001) and Cocaine

E

Embera NeuroTherapeutics

Status and phase

Completed
Phase 1

Conditions

Cocaine Use Disorder

Treatments

Drug: Placebo
Drug: EMB-001
Drug: Saline IV
Drug: Cocaine IV

Study type

Interventional

Funder types

Industry
NIH

Identifiers

NCT02856854
U01DA038879 (U.S. NIH Grant/Contract)
ERL-002

Details and patient eligibility

About

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.

Full description

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.

Enrollment

18 patients

Sex

All

Ages

21 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • non-treatment-seeking cocaine users with a positive urine toxicology screen for cocaine at least once during screening
  • have a medical history and physical examination that demonstrate no clinically significant contraindication for participating in the study
  • males must use contraception; females must be of non-childbearing potential

Exclusion criteria

  • drug allergies or reactions to metyrapone or benzodiazepines, or severe hypersensitivity reactions (like angioedema) to any drugs
  • history of clinically significant adverse reaction to cocaine
  • a low out-of-range serum cortisol value at screening or subjects who have a heightened likelihood of having adrenal insufficiency, or have signs or a history of adrenal insufficiency or confounders of the levels of cortisol and/or cortisol binding globulin
  • treatment with glucocorticoids
  • history of seizures, benzodiazepine use disorder, respiratory disease, neurologic or neuromuscular disease, liver disease or cardiovascular disease
  • other psychiatric or substance use disorders of clinical significance, or suicidality
  • clinically significant finding on medical history, physical examination, clinical laboratory tests, vital signs or ECGs
  • use of any other drugs
  • abnormal BP or HR
  • positive urine drug screen at for alcohol or any drug other than marijuana (THC) or cocaine
  • positive serology test results for HIV-1/HIV-2 Antibodies, Hepatitis B surface Antigen (HBsAg) or Hepatitis C Antibody (HCVAb)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

18 participants in 2 patient groups, including a placebo group

EMB-001 (oral)
Experimental group
Description:
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).
Treatment:
Drug: Cocaine IV
Drug: Saline IV
Drug: EMB-001
Placebo (oral)
Placebo Comparator group
Description:
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).
Treatment:
Drug: Cocaine IV
Drug: Saline IV
Drug: Placebo

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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