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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
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.
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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
240
Start Date
2024-08-12
Completion Date
2029-03-31
Last Updated
2025-11-05
Healthy Volunteers
Yes
Conditions
Interventions
Buprenorphine Patch
Buprenorphine patch dosing will be individualized based on each participant's current morphine-equivalent dose (per package insert/recommendations; between 5mcg and 20mcg per hour). Dosage based on baseline MEQ (\<30 MEQ = 5mcg/hr patch, 30-80 MEQ =10-15mcg/hour patch; \>80 MEQ = 20mcg/hour patch), which will remain on for 7 days (Phase Ia Days 1-7), as tolerated
Placebo
double-blinded randomization to placebo or transdermal buprenorphine
Transcranial Magnetic Stimulation (TMS)
double-blinded randomization to REAL intermittent theta burst (iTBS) rTMS
Sham Transcranial Magnetic Stimulation (TMS)
double-blinded randomization to SHAM intermittent theta burst (iTBS) rTMS
Locations (1)
Medical University of South Carolina
Charleston, South Carolina, United States