Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06641115
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-11
Brief Title:
Integrated Treatment for Opioid Use Disorder and PTSD
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Integrated Treatment for Co-Occurring Opioid Use Disorder and Posttraumatic Stress Disorder
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
This study will test a therapy intervention HOPE for individuals with opioid use disorder and posttraumatic stress disorder Interested individuals will need to be taking medications for opioid use disorder eg suboxone naltrexone methadone Interested participants will complete a 10-12 week therapy and be asked to complete surveys
Detailed Description:
Up to half of individuals with OUD have PTSD but to date there are no established evidence-based behavioral interventions that concurrently address OUD and PTSD symptoms The proposed study directly addresses this major clinical gap by testing whether augmenting medications for OUD by testing an adapted trauma-focused integrated behavioral treatment for substance use disorders and co-occurring PTSD ie Helping Opioid Use and PTSD with Exposure HOPE will enhance clinical outcomes The investigators will test HOPE combined with medications for OUD MOUD versus MOUD-only in a randomized clinical trial among 76 individuals with OUD and PTSD to evaluate feasibility and preliminary efficacy in reducing opioid use and PTSD severity Both conditions will also complete ecological momentary assessments EMA to assess for daily opioid use craving and PTSD symptoms EMA will allow for the assessment of the associations between daily PTSD symptoms and opioid craving and use which may then inform treatment development
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