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

Last updated: October 23, 2024
Sponsor: Medical University of South Carolina
Overall Status: Active - Recruiting

Phase

1/2

Condition

Chronic Pain

Pain

Treatment

Sham Transcranial Magnetic Stimulation (TMS)

Transcranial Magnetic Stimulation (TMS)

Placebo

Clinical Study ID

NCT06442566
Pro00130123
1R01DA058620
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Inclusion

Inclusion Criteria:

  • Age ≥ 18yrs;

  • English-speaking;

  • On LTOT, defined as taking daily prescription opioid therapy for 90 days or more;

  • Past week average morphine equivalent dose (MED) ≥50;

  • 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 followinglist:

  • Taking benzodiazepines with opioids

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

  • Having ever experienced an overdose

  • Current major medical problem [e.g. mod-severe liver disease, pancreatitis, chronicpulmonary disease, untreated sleep apnea, hospitalized for an acute medical issue inthe past 6 months]

  • Response to Brief Pain Iinventory Item 8 <30%, suggesting less than moderatelyclinically meaningful response to pain treatment

  • Co-morbid psychiatric diagnosis [Opioid Risk Tool]

  • Signs of opioid misuse [any score >0 on the following COMM Items: 3, 4, 5, 9, 10, 11, 14, 15, 16]

  • Opioid Risk Tool >3 or Current Opioid Misuse Measure ≥ 9

  • Struggling with the following side effects from opioids [self-report]: Dizzinessand/or falls Difficult-to-manage stomach pain, nausea, constipation or GI issues,Fatigue or low energy, Sleepiness or sedation, Trouble with memory or thinkingclearly [COMM Item 1>0], Other troublesome side effect [open answer]

Exclusion

Exclusion Criteria:

  • Known seizure disorder;

  • On anti-convulsant medication;

  • Known allergy to buprenorphine;

  • Active moderate or severe non-opioid substance use disorder (DSMV criteria);

  • Active suicidal Ideation;

  • Known bipolar disorder;

  • Cognitive disorder limiting ability to consent or fully participate in the BCIintervention;

  • Severe medical condition (e.g. malignancy), likely to limit life expectancy or studyparticipation;

  • Receiving methadone or buprenorphine treatment for OUD or pain;

  • On naltrexone;

  • Pregnancy;

  • Currently Incarcerated;

  • Hypokalemia;

  • Clinically unstable cardiac or pulmonary disease;

  • Taking medications that prolong QTc interval or personal/immediate family history ofLong QT Syndrome.

Study Design

Total Participants: 240
Treatment Group(s): 4
Primary Treatment: Sham Transcranial Magnetic Stimulation (TMS)
Phase: 1/2
Study Start date:
August 12, 2024
Estimated Completion Date:
March 31, 2029

Study Description

With little evidence available to guide the provision of clinical care for patients on long-term opioid therapy (LTOT) in whom the risks outweigh the benefits, major questions remain about optimizing the risk/benefit profile of LTOT, including: how to best engage patients voluntarily in this process; the safety, tolerability and effectiveness of newer treatment approaches; and optimal treatment selection. The primary objective of the proposed study is to begin to systematically address gaps in this important area to improve pain, reduce risk, and improve quality of life for individuals on LTOT.

Connect with a study center

  • Medical University of South Carolina

    Charleston, South Carolina 29407
    United States

    Active - Recruiting

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