Sequential Trial of Adding Buprenorphine, Cognitive Behavioral Treatment, and Transcranial Magnetic Stimulation to Improve Outcomes of Long-Term Opioid Therapy for Chronic Pain (ACTION)
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.
• Age ≥ 18yrs;
• English-speaking;
• On LTOT, defined as taking daily prescription opioid therapy for 90 days or more;
• Past week average morphine equivalent dose (MED) ≥50;
• 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:
• Taking benzodiazepines with opioids
• Substance Use Disorder diagnosis \[non-tobacco; Opioid Risk Tool\]
• Having ever experienced an overdose
• Current major medical problem \[e.g. mod-severe liver disease, pancreatitis, chronic pulmonary disease, untreated sleep apnea, hospitalized for an acute medical issue in the past 6 months\]
• Response to Brief Pain Iinventory Item 8 \<30%, suggesting less than moderately clinically meaningful response to pain treatment
• Co-morbid psychiatric diagnosis \[Opioid Risk Tool\]
• Signs of opioid misuse \[any score \>0 on the following COMM Items: 3, 4, 5, 9, 10, 11, 14, 15, 16\]
• Opioid Risk Tool \>3 or Current Opioid Misuse Measure ≥ 9
• Struggling with the following side effects from opioids \[self-report\]: Dizziness and/or falls Difficult-to-manage stomach pain, nausea, constipation or GI issues, Fatigue or low energy, Sleepiness or sedation, Trouble with memory or thinking clearly \[COMM Item 1\>0\], Other troublesome side effect \[open answer\]