Trial of Adding Buprenorphine Patch, Cognitive Behavioral Therapy, and Transcranial Magnetic Stimulation to Improve Outcomes in Adults on Long-Term Opioid Therapy for Chronic Pain

What this Trial Is About

Researchers are evaluating three new and scalable treatments for individuals at risk who are on long-term opioid therapy LTOT for chronic pain. The study aims to improve pain management, reduce risks, and enhance quality of life by assessing low-dose transdermal buprenorphine without opioid withdrawal, a brief Cognitive Behavioral Intervention for pain CBI, and accelerated repetitive Transcranial Magnetic Stimulation rTMS over the left dorsolateral prefrontal cortex. This study addresses important gaps in care for patients on LTOT where risks may outweigh benefits. Participants receive personalized buprenorphine patch doses based on their current opioid use, applied for 7 days during the first phase. They may be randomly assigned to receive either the real or placebo buprenorphine patch and real or sham rTMS in a double-blinded manner. The study also includes a brief Cognitive Behavioral Intervention. Treatment effects are measured at baseline, during treatment, and at follow-ups scheduled at 4, 12, 24, and 52 weeks. During the study, participants will complete clinical assessments including pain severity and buprenorphine tolerability up to day 20. Quality of life and transition rates to buprenorphine are also tracked. Researchers will monitor participants closely through repeated standardized outcome measures and follow-up visits over a year. Participation involves consenting, using mobile phones for communication, and attending scheduled visits for assessments and treatments.

ACTION: Trial of Adding Buprenorphine, CBT, and TMS to Improve Outcomes of Long-Term Opioid Therapy for Chronic Pain