Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06545071
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-05
Brief Title:
Autonomous Digital CBT Intervention for Opioid Use Disorder in Individuals With Co-Occurring Internalizing Disorders
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Autonomous Digital CBT Intervention for Opioid Use Disorder in Individuals With Co-Occurring Internalizing Disorders - UG3
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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 primary objective of this protocol is to implement the UG3 phase Phase 1 of a National Institute on Drug Abuse NIDA UG3UH3 grant RFA-DA-23-049 This phase is dedicated to the pilot testing of NEAT-O a digital Cognitive Behavioral Therapy CBT program tailored for individuals with opioid use disorder OUD and concurrent anxiety or mood disorders - collectively referred to as internalizing disorders INTDs NEAT-O is based on an empirically supported CBT framework specifically modified to address the complexities of comorbidity in substance use disorders SUDs This pilot study will evaluate the usability and acceptability of NEAT-O in 15 participants with OUD with the goal of refining the program39s content and delivery methods The results of the pilot study will inform a comprehensive RCT in the UH3 Phase Phase 2 N300 Progression to the UH3 phase with its funding depends on meeting milestones in Phase 1 including demonstrating protocol adherence and the program39s acceptability and usability
Detailed Description:
None
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