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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of South Carolina

About this trial

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.

Eligibility criteria

Qualifiers

Taking benzodiazepines with opioids

Substance Use Disorder diagnosis [non-tobacco; Opioid Risk Tool]

Dizziness and/or falls

Difficult-to-manage stomach pain, nausea, constipation or GI issues

Disqualifiers

. Those with nicotine use disorder.

. Those meeting criteria for prescription opioid use disorder using only prescribed opioids will be considered on a case-by-case basis.

Trial design

Treatments tested in this trial

  • Buprenorphine Patch
  • Placebo
  • Transcranial Magnetic Stimulation (TMS)
  • Sham Transcranial Magnetic Stimulation (TMS)

Treatment groups

240 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Medical University of South Carolina

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator