Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06580444
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
Brexanolone to Target Concurrent PTSD and Stress Induced Alcohol Use in Veterans A Dose Finding Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Brexanolone to Target Concurrent Posttraumatic Stress Disorder PTSD and Stress Induced Alcohol Use in Veterans A Dose Finding Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research study is to find out how Zulressobrexanolone influences Posttraumatic Stress Disorder PTSD symptoms and alcohol use
Detailed Description:
The overall objectives of this study are to establish the safety of administering 90 60 and 30mcgkgh target doses of brexanolone BREX 20-hour infusion versus placebo and investigate efficacy of each dose to reduce PTSD symptoms alcohol consumption and stress reactivity via mood-induction paradigms in individuals with PTSDAUD
The primary aims of this study are to
1 Evaluate the safety and tolerability of BREX 90 60 and 30 mcgkgh among individuals with PTSDAUD
2 Investigate the medication effect of the 90 60 and 30 mcgkgh doses of BREX to reduce alcohol consumption and PTSD symptoms in men and women with PTSDAUD
The secondary aim of this study is to
1 Investigate the medication effect of each of the 90 60 30 mcgkgh doses of BREX to reduce stress reactivity via mood-induction paradigm in men and women with PTSDAUD
The exploratory aim of this study is to
1 Explore sex-specific responses to brexanolones effect on PTSD and alcohol use among men and women with PTSDAUD
The primary aims of this study are to
1 Evaluate the safety and tolerability of BREX 90 60 and 30 mcgkgh among individuals with PTSDAUD
2 Investigate the medication effect of the 90 60 and 30 mcgkgh doses of BREX to reduce alcohol consumption and PTSD symptoms in men and women with PTSDAUD
The secondary aim of this study is to
1 Investigate the medication effect of each of the 90 60 30 mcgkgh doses of BREX to reduce stress reactivity via mood-induction paradigm in men and women with PTSDAUD
The exploratory aim of this study is to
1 Explore sex-specific responses to brexanolones effect on PTSD and alcohol use among men and women with PTSDAUD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None