drugset / Trial / NCT06442566
ACTION: Trial of Adding Buprenorphine, CBT, and TMS to Improve Outcomes of Long-Term Opioid Therapy for Chronic Pain
Phase 1/2
Recruiting
240 enrolled
Medical University of South Carolina
National Institute on Drug Abuse (NIDA) · collab
RandomizedSequentialDouble-blindTreatment
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.
Timeline
- Start
- 2024-08-12
- Primary completion
- 2028-03-31
- Completion
- 2029-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Buprenorphine | Other / unclassified | 5 ug | Other |
| Subject | Buprenorphine | Other / unclassified | 10 ug | Other |
| Subject | Buprenorphine | Other / unclassified | 15 ug | Other |
| Subject | Buprenorphine | Other / unclassified | 20 ug | Other |