Actively Recruiting
Sequential Trial of Adding Buprenorphine, Cognitive Behavioral Treatment, and Transcranial Magnetic Stimulation to Improve Outcomes of Long-Term Opioid Therapy for Chronic Pain (ACTION)
Led by Medical University of South Carolina · Updated on 2025-11-05
240
Participants Needed
1
Research Sites
52 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
Researchers are evaluating three new and scalable treatments for individuals at risk who are on long-term opioid therapy (LTOT) for chronic pain. The study aims to improve pain management, reduce risks, and enhance quality of life by assessing low-dose transdermal buprenorphine without opioid withdrawal, a brief Cognitive Behavioral Intervention for pain (CBI), and accelerated repetitive Transcranial Magnetic Stimulation (rTMS) over the left dorsolateral prefrontal cortex. This study addresses important gaps in care for patients on LTOT where risks may outweigh benefits. Participants receive personalized buprenorphine patch doses based on their current opioid use, applied for 7 days during the first phase. They may be randomly assigned to receive either the real or placebo buprenorphine patch and real or sham rTMS in a double-blinded manner. The study also includes a brief Cognitive Behavioral Intervention. Treatment effects are measured at baseline, during treatment, and at follow-ups scheduled at 4, 12, 24, and 52 weeks. During the study, participants will complete clinical assessments including pain severity and buprenorphine tolerability up to day 20. Quality of life and transition rates to buprenorphine are also tracked. Researchers will monitor participants closely through repeated standardized outcome measures and follow-up visits over a year. Participation involves consenting, using mobile phones for communication, and attending scheduled visits for assessments and treatments.
CONDITIONS
Brief 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
- Taking daily prescription opioid therapy for 90 days or more
- Past week average morphine equivalent dose of 20 mg or higher
- 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 benzodiazepine use with opioids, substance use disorder (non-tobacco), history of overdose, major medical problems, less than moderate pain treatment response, psychiatric diagnosis, signs of opioid misuse, high opioid risk scores, or troublesome opioid side effects
You will not qualify if you...
- Known allergy to buprenorphine
- Active moderate or severe substance use disorder except nicotine use disorder or prescription opioid use disorder on a case-by-case basis
- 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 or personal/family history of Long QT Syndrome
- Significant or unstable medical or psychiatric conditions impacting safe participation
- Enrolled in another clinical trial or received investigational medication/device within 30 days
- Contraindications to transcranial magnetic stimulation, such as ferromagnetic implants or seizure risk factors
- No identifiable motor threshold for TMS determination by investigators
- Other conditions or treatments affecting safe study participation as determined by investigators
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 days
Participants begin using a buprenorphine patch with dosage individualized based on their current opioid dose for 7 days.
Daily visits or contacts during the 7 days
Duration - Up to 20 days
Participants receive randomized treatment with buprenorphine patch or placebo and randomized real or sham Transcranial Magnetic Stimulation (TMS) to assess tolerability and effectiveness.
Multiple visits during treatment period, including device sessions and medication monitoring
Duration - Up to Day 20 post-treatment start
Participants are monitored for buprenorphine transition and quality of life outcomes after treatment.
1 to 2 follow-up visits depending on individual progress
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
R
Rafael Mendoza
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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