Ignite Creation Date:
2024-05-06 @ 1:55 PM
Last Modification Date:
2024-10-26 @ 1:22 PM
Study NCT ID:
NCT04169360
Status:
WITHDRAWN
Last Update Posted:
2021-01-28
First Post:
2019-11-05
Brief Title:
Safety and Preliminary Efficacy of ANS-6637 to Reduce Drug Craving and Harm in People With Opioid Use Disorder
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Safety and Preliminary Efficacy of ANS-6637 to Reduce Drug Craving and Harm in People With Opioid Use Disorder
Status:
WITHDRAWN
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The FDA determined that there is not adequate safety information to continue clinical investigations using ANS-6637 and Amygdala Neurosciences the product company of ANS-6637 is no longer pursuing research with this compound
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SEARCH
Brief Summary:
This is a double blind placebo controlled randomized trial to evaluate the safety and preliminary efficacy of ANS-6637 in adults with opioid use disorder with and without opioid agonist therapy Patients will be randomized to two arms 1 ANS-6637 for three months vs 2 Placebo for three months Subjects will subsequently be followed for an additional one month post treatment
Detailed Description:
This is a double blind placebo controlled randomized trial to evaluate the safety and preliminary efficacy of ANS-6637 in adults with opioid use disorder with and without opioid agonist therapy At screening after providing consent participants will be evaluated to ensure criteria for opioid use disorder by DSM V criteria is met and whether the subject is receiving opioid agonist therapy will be determined Participants will undergo a medical evaluation including medical history laboratory tests and EKG evaluation to establish baseline medical and psychiatric diagnosis in order to ensure safety of participation Once enrollment criteria are met patients will be randomized in a blinded fashion to ANS-6637 or placebo stratified by site and form of opioid agonist therapy On Day 0 patients will be initiated on ANS-6637 vs placebo according to randomization group Subjects will be seen twice per week for two weeks followed by weekly for two weeks and then monthly for two months
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