Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06442566
PHASE1/PHASE2

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

View on ClinicalTrials.gov

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

Interventions

DRUG

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

DRUG

Placebo

double-blinded randomization to placebo or transdermal buprenorphine

DEVICE

Transcranial Magnetic Stimulation (TMS)

double-blinded randomization to REAL intermittent theta burst (iTBS) rTMS

DEVICE

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