ACTION: Trial of Adding Buprenorphine, CBT, and TMS to Improve Outcomes of Long-Term Opioid Therapy for Chronic Pain
RecruitingPhase 1, Phase 2NCT06442566
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Sequential Trial of Adding Buprenorphine, Cognitive Behavioral Treatment, and Transcranial Magnetic Stimulation to Improve Outcomes of Long-Term Opioid Therapy for Chronic Pain (ACTION)
- Conditions
- Opioid Withdrawal
- Chronic Pain
- Interventions
- Drug: Buprenorphine Patch
- Drug: Placebo
- Device: Transcranial Magnetic Stimulation (TMS)
- Device: Sham Transcranial Magnetic Stimulation (TMS)
- Sponsor
- Medical University of South Carolina
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Start date
- 2024-08-12
- Primary completion
- 2028-03-31
- Sex
- All
- Age range
- from 18 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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 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 \[self-report\] 1. Dizziness and/or falls 2. Difficult-to-manage stomach pain, nausea, constipation or GI issues 3. Fatigue or low energy 4. Sleepiness or sedation 5. Trouble with memory or thinking clearly \[COMM Item 1\>0\] 6. Other troublesome side effect \[open answer\] Exclusion criteria: Known allergy to buprenorphine Active moderate or severe substance use disorder with the exception of those listed below: 1. . Those with nicotine use disorder. 2. . Those meeting criteria for prescription opioid use disorder using only prescribed opioids will be considered on a case-by-case basis. Cognitive disorder limiting ability to consent or fully participate in the brief cognitive intervention Receiving methadone or buprenorphine treatment for OUD or pain Taking naltrexone Pregnancy Currently incarcerated Taking medications that prolong QTc interval, as determined by study investigators Personal/immediate family history of Long QT Syndrome. Significant or unstable condition/s or treatments that may impact safe participation in the study (as determined by the study investigators) such as significant cardiac condition (e.g. poorly-controlled heart failure, current or past cardiac arrhythmia, sustained systolic blood pressure \>180), significant metabolic disorder (e.g. labile diabetes, significant electrolyte abnormality), canc…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06442566