Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04501874
Status:
COMPLETED
Last Update Posted:
2023-08-08
First Post:
2020-08-03
Brief Title:
A Study to Evaluate EMB 001 in Subjects With Cocaine Use Disorder
Sponsor:
Embera NeuroTherapeutics Inc
Organization:
Embera NeuroTherapeutics Inc
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
This is a Phase 2 study in approximately 80 adult subjects with moderate-to-severe Cocaine Use Disorder CUD
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 11 ratio n40arm to one of the following for the Treatment Period weeks 2 - 13 on Study Day 8
EMB-001 720 mg metyrapone24 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 2408 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
After undergoing study procedures during the Screening and Baseline Periods subjects who meet inclusion and exclusion criteria will then be randomized in a 11 ratio n40arm to one of the following for the Treatment Period weeks 2 - 13 on Study Day 8
EMB-001 720 mg metyrapone24 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 2408 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5U01DA038879-03 | NIH | None | httpsreporternihgovquickSearch5U01DA038879-03 |