Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06442566
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-29
Brief Title:
ACTION Trial of Adding Buprenorphine CBT and TMS to Improve Outcomes of Long-Term Opioid Therapy for Chronic Pain
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
Sequential Trial of Adding Buprenorphine Cognitive Behavioral Treatment and Transcranial Magnetic Stimulation to Improve Outcomes of Long-Term Opioid Therapy for Chronic Pain ACTION
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
ACTION
Brief Summary:
This study will sequentially evaluate three novel and scalable interventions for at-risk individuals on long term opioid therapy for chronic pain 1 low-dose transdermal buprenorphine initiation without a period of opioid withdrawal 2 a brief Cognitive Behavioral Intervention for pain CBI and 3 accelerated rTMS over the left dorsolateral prefrontal cortex by examining standardized repeated measures of clinical outcomes at baseline during treatment and at 4- 12- 24- and 52-week follow-up
Detailed Description:
With little evidence available to guide the provision of clinical care for patients on long-term opioid therapy LTOT in whom the risks outweigh the benefits major questions remain about optimizing the riskbenefit profile of LTOT including how to best engage patients voluntarily in this process the safety tolerability and effectiveness of newer treatment approaches and optimal treatment selection The primary objective of the proposed study is to begin to systematically address gaps in this important area to improve pain reduce risk and improve quality of life for individuals on LTOT
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01DA058620 | NIH | None | httpsreporternihgovquickSearch1R01DA058620 |