Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06367387
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-04-03
Brief Title:
Pain Self-Management and Patient-Oriented Dosing for Pain and in Retention Opioid Treatment
Sponsor:
Jessica Merlin
Organization:
University of Pittsburgh
Study Overview
Official Title:
Pain Self-Management and Patient-Oriented Dosing for Pain and Retention in Office-based Addiction Treatment a Randomized Trial
Status:
RECRUITING
Status Verified Date:
2024-08
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:
TREETOP
Brief Summary:
This study seeks to improve the treatment of chronic pain in people who are taking buprenorphine also known as Suboxone Subutex Zubsolv
The research study is testing two different interventions along with usual clinical care
1 Pain Self-Management PSM an educational program in which individuals with chronic pain work with a trained pain coach and a pain peer to explore strategies to effectively manage the daily problems that arise from chronic pain
2 Patient-Oriented Dosing POD an alternative dosing of buprenorphine which will be adjusted based on pain levels
The interventions will take place over a period of 12 weeks 3 months Additionally participants will complete surveys every 3 months for a period of 1 year total of 5 survey visits Participants will receive 50 compensation for each survey visit completed up to 250 over one year and can receive up to an additional 100 bonus compensation
There are risks associated with participating in the study including breach of confidentiality psychological distress caused by discussing difficult topics and risks associated with the POD intervention
The research study is testing two different interventions along with usual clinical care
1 Pain Self-Management PSM an educational program in which individuals with chronic pain work with a trained pain coach and a pain peer to explore strategies to effectively manage the daily problems that arise from chronic pain
2 Patient-Oriented Dosing POD an alternative dosing of buprenorphine which will be adjusted based on pain levels
The interventions will take place over a period of 12 weeks 3 months Additionally participants will complete surveys every 3 months for a period of 1 year total of 5 survey visits Participants will receive 50 compensation for each survey visit completed up to 250 over one year and can receive up to an additional 100 bonus compensation
There are risks associated with participating in the study including breach of confidentiality psychological distress caused by discussing difficult topics and risks associated with the POD intervention
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RM1DA055311 | NIH | None | httpsreporternihgovquickSearchRM1DA055311 |