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

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
Medical University of South Carolina
Study ID
NCT06442566
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Chronic Pain
  • Opioid Withdrawal

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Buprenorphine Patch — DRUG
    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
  • Placebo — DRUG
    double-blinded randomization to placebo or transdermal buprenorphine
  • Transcranial Magnetic Stimulation (TMS) — DEVICE
    double-blinded randomization to REAL intermittent theta burst (iTBS) rTMS
  • Sham Transcranial Magnetic Stimulation (TMS) — DEVICE
    double-blinded randomization to SHAM intermittent theta burst (iTBS) rTMS

Study Details

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.

Key Dates

Start date
Aug 12, 2024
Status verified
Nov 2025
Primary completion
Mar 31, 2028
Completion
Mar 31, 2029

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: open label BUP
  • Active Comparator: Real vs Placebo BUP
  • Active Comparator: Real vs Sham TMS

Primary Outcome Measure

Buprenorphine Tolerability [ Time Frame: up to Day-13 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Medical University of South CarolinaCharlestonSouth Carolina29407
Rafael Mendoza
[email protected]
Kelly Barth (PRINCIPAL_INVESTIGATOR)

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Medical University of South Carolina· Charleston, SC

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