NCT02406066 is a Phase 1 clinical trial of metyrapone & oxazepam in Cocaine Use Disorder, sponsored by Embera NeuroTherapeutics, Inc..

Who is sponsoring NCT02406066?

NCT02406066 is sponsored by Embera NeuroTherapeutics, Inc..

What drugs are being tested in NCT02406066?

Interventions in NCT02406066: metyrapone & oxazepam, metyrapone & oxazepam, metyrapone & oxazepam, Placebo.

What condition does NCT02406066 study?

NCT02406066 studies Cocaine Use Disorder, Tobacco Use Disorder.

Is NCT02406066 still recruiting?

NCT02406066 is currently completed. Last updated 21 July 2016.

Last reviewed 2016-07-21 · How we verify

NCT02406066

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Phase 1 Combined Single and Multiple Rising Dose Study of the Safety and Pharmacokinetics of Metyrapone/Oxazepam Combination (EMB-001)

Completed Phase 1 Last updated 21 July 2016

What this trial tests

Phase 1 trial testing metyrapone & oxazepam in Cocaine Use Disorder in 24 participants. Completed in 1 June 2016.

Timeline

1 March 2015

Primary endpoint
1 December 2015

1 June 2016

Quick facts

Lead sponsor	Embera NeuroTherapeutics, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	24
Start date	1 March 2015
Primary completion	1 December 2015
Estimated completion	1 June 2016
Sites	2 locations across United States

Drugs / interventions tested

metyrapone & oxazepam — full drug profile →
metyrapone & oxazepam — full drug profile →
metyrapone & oxazepam — full drug profile →
Placebo

Conditions studied

Cocaine Use Disorder — all drugs for Cocaine Use Disorder →
Tobacco Use Disorder — all drugs for Tobacco Use Disorder →

Sponsor

Embera NeuroTherapeutics, Inc. — full company profile →

Who can join

Adults 18 to 65, any sex, with Cocaine Use Disorder or Tobacco Use Disorder. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Safety/Tolerability based on multiple safety parameters (adverse events (AE), physical examinations, vital signs, 12-lead ECG, Sheehan Suicidality Tracking Scale (S STS) and laboratory tests)
Time frame: Daily on Days 1-12, and on Day 17. Study Completion occurs on Day 17.
Safety will be assessed through monitoring of adverse events (AE), physical examinations, vital signs, 12-lead ECG, Sheehan Suicidality Tracking Scale (S STS) and laboratory tests.

Sponsor's own description

This is a study of EMB-001 (a combination of two FDA-approved drugs, metyrapone and oxazepam) in otherwise healthy adults who are regular cigarette smokers. There will be 3 groups of 8 subjects; in each group, 6 subjects will get the drug combination and 2 will get placebo. Neither the subjects nor the study personnel will know who got drug and who got placebo (double-blind). In the first group the drug doses will be low, and they will be increased in the second and third groups. Subjects will receive a single dose on Day 1, followed 24 hours later by the start of doses twice daily for 7 days, and then a final morning dose on the last day. The levels of the drugs in the blood will be assessed by repeated blood draws after the first day and after the end of dosing. Safety will be assessed after the single dose and repeated dosing. Effects of study drug on smoking and craving cigarettes will be assessed at the end of repeated dosing. The hypothesis is that this drug combination will be safe, with relatively few side effects.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Cocaine Use Disorder

Currently open trials in the same condition.

NCT07227948 — Repurposing Semaglutide for the Treatment of Cocaine Use Disorder · Phase 2 · recruiting
NCT07086794 — Cocaine and Pentoxifylline (BED IN 47) · EARLY_PHASE1 · recruiting
NCT06050304 — CRACK-TARGET 1: Descriptive Study of Observed Behavioral Sensitization and Expectations · NA · recruiting
NCT07091877 — Cocaine Cue-reactivity Incubation Study · NA · recruiting
NCT05986578 — Identifying Electrophysiological Targets for Transcranial Magnetic Stimulation in Cocaine Use Disorder · NA · recruiting

Other Embera NeuroTherapeutics, Inc. trials

Trials by the same sponsor.

NCT04933916 — Study of EMB-001 as a Potential Smoking Cessation Treatment · Phase 1, PHASE2 · terminated
NCT04501874 — A Study to Evaluate EMB 001 in Subjects With Cocaine Use Disorder · Phase 2 · completed
NCT03404817 — Single Dose Crossover Comparative Bioavailability and Food Effect Study of Two EMB-001 Formulations · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02406066 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Embera NeuroTherapeutics, Inc.
Last refreshed: 21 July 2016

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02406066.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing