NCT06442566 ACTION: Trial of Adding Buprenorphine, CBT, and TMS to Improve Outcomes of Long-Term Opioid Therapy for Chronic Pain

Eligibility & Interventions

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.

This trial targets 240 participants in total. It began in 2024-08-12 with a primary completion date of 2028-03-31.

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.

Eligibility Criteria

Inclusion criteria: Age \>/= 18 years English-speaking On LTOT, defined as taking daily prescription opioid therapy for 90 days or more Past week average morphine equivalent dose (MED) \>/= 20mg Willing and able to complete written informed consent Willing and able to use a mobile/cell phone Have at least one additional risk for opioid toxicity or overdose from the following list: Opioid Toxicity or Overdose Risks: 1. Taking benzodiazepines with opioids 2. Substance Use Disorder diagnosis \[non-tobacco; Opioid Risk Tool\] 2\) Having ever experienced an overdose 4) Current major medical problem \[e.g. mod-severe liver disease, pancreatitis, chronic pulmonary disease, untreated sleep apnea, hospitalized for an acute medical issue in the past 6 months\]a,b 5) Response to BPI Item 8 \<30%, suggesting less than moderately clinically meaningful response to pain treatmentc 6) Co-morbid psychiatric diagnosis \[Opioid Risk Tool\] 7) Signs of opioid misuse \[any score \>0 on the following COMM Items: 3,4,5,9,10,11,14,15,16\] 8)Opioid Risk Tool \>3 or Current Opioid Misuse Measure ≥ 9 9) Struggling with any of the following side effects from opioids \[self-report\] 1. Dizziness and/or falls 2. Difficult-to-manage stomach pain, nausea, constipation or GI issues 3. Fatigue or low energy 4. Sleepiness or sedation 5. Trouble with memory or thinking clearly \[COMM Item 1\>0\] 6. Other troublesome side effect \[open answer\] Exclusion criteria: Known allergy to buprenorphine Active moderate or severe substance use disorder with the exception of those listed below: 1. . Those with nicotine use disorder. 2. . Those meeting criteria for prescription opioid use disorder using only prescribed opioids will be considered on a case-by-case basis. Cognitive disorder limiting ability to consent or fully participate in the brief cognitive intervention Receiving methadone or buprenorphine treatment for OUD or pain Taking naltrexone Pregnancy Currently incarcerated Taking medications that prolong QTc interval, as determined by study investigators Personal/immediate family history of Long QT Syndrome. Significant or unstable condition/s or treatments that may impact safe participation in the study (as determined by the study investigators) such as significant cardiac condition (e.g. poorly-controlled heart failure, current or past cardiac arrhythmia, sustained systolic blood pressure \>180), significant metabolic disorder (e.g. labile diabetes, significant electrolyte abnormality), cancer (e.g. brain cancer, chemotherapy-induced cognitive impairment), major psychiatric disorder (e.g. active bipolar disorder, schizophrenia spectrum or other psychotic disorder, suicidal/homicidal intent within the past month, or any suicide attempts within the past year or current active suicidal ideation, as determined by medical clinician), developmental disorder (e.g. autism spectrum disorder, intellectual disability), or other neurologic disease (e.g. movement disorder, multiple sclerosis, moderate to severe brain injury). Enrolled in a clinical trial or has received an investigational medication or device in the last 30 days. TMS contraindications (e.g., ferromagnetic implants, conditions or treatments that lower seizure threshold, taking contraindicated medications, no identifiable motor threshold, as determined by study investigators).

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