Sequential Trial of Adding Buprenorphine, Cognitive Behavioral Treatment, and Transcranial Magnetic Stimulation to Improve Outcomes of Long-Term Opioid Therapy for Chronic Pain (ACTION)
Medical University of South Carolina
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.
Description
With little evidence available to guide the provision of clinical care for patients on long-term opioid therapy (LTOT) in whom the risks outweigh the benefits, major questions remain about optimizing the risk/benefit profile of LTOT, including: how to best engage patients voluntarily in this process; the safety, tolerability and effectiveness of newer treatment approaches; and optimal treatment selection. The primary objective of the proposed study is to begin to systematically address gaps in this important area to improve pain, reduce risk, and improve quality of life for individuals on LTOT…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
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 medic…
Interventions
- DrugBuprenorphine 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
- DrugPlacebo
double-blinded randomization to placebo or transdermal buprenorphine
- DeviceTranscranial Magnetic Stimulation (TMS)
double-blinded randomization to REAL intermittent theta burst (iTBS) rTMS
- DeviceSham Transcranial Magnetic Stimulation (TMS)
double-blinded randomization to SHAM intermittent theta burst (iTBS) rTMS
Location
- Medical University of South CarolinaCharleston, South Carolina