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 \>/= 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:
• Taking benzodiazepines with opioids
• 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 \[self-report\]
• 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 \[open answer\]