Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06359340
Status:
RECRUITING
Last Update Posted:
2024-04-11
First Post:
2020-03-02
Brief Title:
Therapy and Peer Support for Patients Taking Medication for Opioid Use Disorder
Sponsor:
Public Health Management Corporation
Organization:
Public Health Management Corporation
Study Overview
Official Title:
Identifying Optimal Psychosocial Interventions for Patients Receiving Office-Based Buprenorphine
Status:
RECRUITING
Status Verified Date:
2024-04
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:
Current clinical guidelines for medication assisted treatment MAT of opioid use disorder OUD recommend that treatment include a psychosocial component to help address psychological factors related to addiction However a knowledge gap exists regarding the most effective forms of psychosocial intervention and what interventions are most effective for different types of patients This gap represents a significant barrier to the widespread implementation of effective office-based opioid treatment OBOT with buprenorphine which is important to improving opioid treatment and responding to the critical needs of individuals living with OUD The overarching goal of this patient-centered research is to address the diverse needs and preferences of OUD patients in regards to psychosocial approaches and to overcome the one-size-fits-all strategies that are typically used to treat OUD Importantly the investigators arrived at this goal in part through collaboration and consultation with former patients who have received different types of treatments for OUD In this manner patients provided important insight to inform the selection of interventions to be evaluated patient characteristics that may differentially impact the effects of the interventions and the patient outcomes to be examined
Detailed Description:
The study will evaluate the comparative effectiveness of two psychosocial approaches Cognitive Behavioral Therapy and peer support through the use of Certified Recovery Specialists provided within the context of office-based buprenorphine treatment Patients will be randomly assigned to receive either 1 standard Medication Management MM as typically provided at the site 2 MM with office-based CBT 3 MM with CRS and 4 MM with both CBT and CRS In MM patients will be seen by providers at least weekly until stable and stabilized patients will then be seen by the provider on a monthly basis If a patient needs a higher level of care they will be referred to appropriate specialty treatment to ensure their safety In the CBT study arms CBT will be provided through 12 individual manualized sessions scheduled to coincide with patients MM appointments when possible As outlined by the National Institute on Drug Abuse NIDA sessions will cover standard CBT topics and include exercises and homework Meta-analyses and reviews have concluded that CBT is an effective treatment across a range of SUDs and has helped to enhance treatment retention improve medication adherence and address ancillary problems In the CRS study arms CRSs will meet with clients following their first OBOT session to assist them in accessing community resources and overcoming treatment barriers and provide ongoing patient navigation services to promote attendance at OBOT appointments These appointments will occur either in-person or over the phone and all meetings will be tracked by the CRS Studies indicate that peer-delivered services for individuals with mental health disorders are effective in engaging difficult-to-reach individuals and improving multidimensional outcomes In the combined CBTCRS study arm clients will receive the individual CBT sessions and be assigned to a CRS
Study Oversight
Has Oversight DMC:
None
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?:
True
Is an FDA AA801 Violation?:
None