Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06384157
Status:
RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-04-22
Brief Title:
Proof of Concept and Dose-ranging Study of INDV-2000 in Individuals with Moderate to Severe Opioid Use Disorder
Sponsor:
Indivior Inc
Organization:
Indivior Inc
Study Overview
Official Title:
A Phase II Double Blind Placebo Controlled Randomised Dose-Ranging Study to Assess the Safety and Efficacy of INDV-2000 Over 3 Months in Treatment Seeking Individuals with Opioid Use Disorder
Status:
RECRUITING
Status Verified Date:
2024-08
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:
The purpose of this study is to measure safety and efficacy and to determine dose-response relationship for INDV-2000 in participants with moderate to severe Opioid Use Disorder OUD who are new to treatment have recently initiated or completed short-term medically supervised withdrawal with transmucosal TM buprenorphine and are interested in transitioning to a non opioid treatment
Detailed Description:
From Day 1 to Day 7 TM buprenorphine and randomized INDV-2000Placebo will be administered INDV-2000Placebo will be administered alone from Day 8 onward The randomized treatment period starts when the participant receives randomized treatment at Day 1 and ends at hisher last study visit if on INDV-2000Placebo alone or ends when starting buprenorphine rescue therapy
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