Actively Recruiting
ACTION: Trial of Adding Buprenorphine, CBT, and TMS to Improve Outcomes of Long-Term Opioid Therapy for Chronic Pain
Led by Medical University of South Carolina · Updated on 2025-11-05
240
Participants Needed
1
Research Sites
241 weeks
Total Duration
On this page
Sponsors
M
Medical University of South Carolina
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
ACTION: Trial of Adding Buprenorphine, CBT, and TMS to Improve Outcomes of Long-Term Opioid Therapy for Chronic Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- English-speaking
- On long-term opioid therapy, defined as daily prescription opioid use for 90 days or more
- Average morphine equivalent dose of at least 20 mg in past week
- Willing and able to provide written informed consent
- Willing and able to use a mobile or cell phone
- Have at least one additional risk factor for opioid toxicity or overdose, such as taking benzodiazepines with opioids, substance use disorder diagnosis (non-tobacco), history of overdose, major medical problem (e.g., moderate to severe liver disease, pancreatitis, chronic pulmonary disease, untreated sleep apnea, recent hospitalization), less than moderate response to pain treatment, co-morbid psychiatric diagnosis, signs of opioid misuse, high opioid risk tool score, or struggling with opioid side effects like dizziness, stomach pain, fatigue, sleepiness, memory problems, or other troublesome effects
You will not qualify if you...
- Known allergy to buprenorphine
- Active moderate or severe substance use disorder except nicotine use disorder or certain prescription opioid use disorder cases
- Cognitive disorder limiting consent or participation in cognitive intervention
- Receiving methadone or buprenorphine treatment for opioid use disorder or pain
- Taking naltrexone
- Pregnancy
- Currently incarcerated
- Taking medications that prolong QTc interval
- Personal or immediate family history of Long QT Syndrome
- Significant or unstable conditions impacting safe participation, such as serious cardiac condition, metabolic disorder, cancer, major psychiatric disorder, developmental disorder, or neurologic disease
- Enrolled in another clinical trial or received investigational medication/device in last 30 days
- Contraindications for transcranial magnetic stimulation like ferromagnetic implants, seizure risk, or no identifiable motor threshold
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Medical University of South Carolina
Charleston, South Carolina, United States, 29407
Actively Recruiting
Research Team
K
Kelly Barth
CONTACT
R
Rafael Mendoza
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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