Ignite Creation Date:
2025-12-26 @ 10:32 AM
Ignite Modification Date:
2025-12-31 @ 11:58 PM
Study NCT ID:
NCT06513728
Status:
COMPLETED
Last Update Posted:
2025-08-08
First Post:
2024-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study of Methadone Patient Access to Collaborative Treatment: a HEAL Initiative
Sponsor:
University of Arizona
Organization:
Study Overview
Official Title:
Methadone Patient Access to Collaborative Treatment
Status:
COMPLETED
Status Verified Date:
2025-05
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:
MPACT
Brief Summary:
Examine the preliminary effect of the MPACT intervention on methadone treatment retention, in treatment overdose and patient trauma symptoms. The study will also explore the relationship between staff trauma symptoms and MPACT implementation.
Detailed Description:
Specific AIMS:
AIM 1: Develop MPACT through multilevel, iterative planning with OTP staff and people with recent MMT experience.
AIM 2: Conduct a 4-month MPACT pilot test in two AZ OTPs: Mesa (urban) with 50 patients and 22 staff, and Sierra Vista (rural-serving) with 50 patients and 8 staff to:
1. Determine MPACT implementation feasibility, acceptability, and preliminary effect on MMT practice change and culture.
2. Determine MPACT preliminary effect on MMT retention, in-MMT overdose, and patient PTSS.
3. Characterize staff trauma history, PTSS and vicarious trauma, and explore their relationship with MPACT acceptability and implementation fidelity.
AIM 3: Characterize MPACT acceptability, likely adoption, and recruitment feasibility among directors, case managers and counselors from a national random sample of 500 OTPs.
AIM 1: Develop MPACT through multilevel, iterative planning with OTP staff and people with recent MMT experience.
AIM 2: Conduct a 4-month MPACT pilot test in two AZ OTPs: Mesa (urban) with 50 patients and 22 staff, and Sierra Vista (rural-serving) with 50 patients and 8 staff to:
1. Determine MPACT implementation feasibility, acceptability, and preliminary effect on MMT practice change and culture.
2. Determine MPACT preliminary effect on MMT retention, in-MMT overdose, and patient PTSS.
3. Characterize staff trauma history, PTSS and vicarious trauma, and explore their relationship with MPACT acceptability and implementation fidelity.
AIM 3: Characterize MPACT acceptability, likely adoption, and recruitment feasibility among directors, case managers and counselors from a national random sample of 500 OTPs.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
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?: