RECRUITING

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

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Conditions

Opioid WithdrawalChronic Painopioids, long-term opioid use, chronic pain, TMS

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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)

Quick Facts

Study Start:2024-08-12
Study Completion:2029-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06442566

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18yrs;
  2. * English-speaking;
  3. * On LTOT, defined as taking daily prescription opioid therapy for 90 days or more;
  4. * Past week average morphine equivalent dose (MED) ≥50;
  5. * Willing and able to complete written informed consent;
  6. * Willing and able to use a mobile/cell phone;
  7. * Have at least one additional risk for opioid toxicity or overdose from the following list:
  8. * Taking benzodiazepines with opioids
  9. * Substance Use Disorder diagnosis \[non-tobacco; Opioid Risk Tool\]
  10. * Having ever experienced an overdose
  11. * Current major medical problem \[e.g. mod-severe liver disease, pancreatitis, chronic pulmonary disease, untreated sleep apnea, hospitalized for an acute medical issue in the past 6 months\]
  12. * Response to Brief Pain Iinventory Item 8 \<30%, suggesting less than moderately clinically meaningful response to pain treatment
  13. * Co-morbid psychiatric diagnosis \[Opioid Risk Tool\]
  14. * Signs of opioid misuse \[any score \>0 on the following COMM Items: 3, 4, 5, 9, 10, 11, 14, 15, 16\]
  15. * Opioid Risk Tool \>3 or Current Opioid Misuse Measure ≥ 9
  16. * Struggling with the following side effects from opioids \[self-report\]: Dizziness and/or falls Difficult-to-manage stomach pain, nausea, constipation or GI issues, Fatigue or low energy, Sleepiness or sedation, Trouble with memory or thinking clearly \[COMM Item 1\>0\], Other troublesome side effect \[open answer\]
  1. * Known seizure disorder;
  2. * On anti-convulsant medication;
  3. * Known allergy to buprenorphine;
  4. * Active moderate or severe non-opioid substance use disorder (DSMV criteria);
  5. * Active suicidal Ideation;
  6. * Known bipolar disorder;
  7. * Cognitive disorder limiting ability to consent or fully participate in the BCI intervention;
  8. * Severe medical condition (e.g. malignancy), likely to limit life expectancy or study participation;
  9. * Receiving methadone or buprenorphine treatment for OUD or pain;
  10. * On naltrexone;
  11. * Pregnancy;
  12. * Currently Incarcerated;
  13. * Hypokalemia;
  14. * Clinically unstable cardiac or pulmonary disease;
  15. * Taking medications that prolong QTc interval or personal/immediate family history of Long QT Syndrome.

Contacts and Locations

Study Contact

Kelly Barth
CONTACT
843-792-0686
stephen@musc.edu
Rafael Mendoza
CONTACT
mendozra@musc.edu

Principal Investigator

Kelly Barth
PRINCIPAL_INVESTIGATOR
Medical University of South Carolina

Study Locations (Sites)

Medical University of South Carolina
Charleston, South Carolina, 29407
United States

Collaborators and Investigators

Sponsor: Medical University of South Carolina

  • Kelly Barth, PRINCIPAL_INVESTIGATOR, Medical University of South Carolina

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-12
Study Completion Date2029-03-31

Study Record Updates

Study Start Date2024-08-12
Study Completion Date2029-03-31

Terms related to this study

Keywords Provided by Researchers

  • opioids, long-term opioid use, chronic pain, TMS

Additional Relevant MeSH Terms

  • Opioid Withdrawal
  • Chronic Pain