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

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.

Conditions

Opioid Withdrawal, Chronic Pain

Study Overview

Study Details

Study overview

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.

Sequential Trial of Adding Buprenorphine, Cognitive Behavioral Treatment, and Transcranial Magnetic Stimulation to Improve Outcomes of Long-Term Opioid Therapy for Chronic Pain (ACTION)

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

Condition
Opioid Withdrawal
Intervention / Treatment

-

Contacts and Locations

Charleston

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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 following list:
  • * Taking benzodiazepines with opioids
  • * Substance Use Disorder diagnosis \[non-tobacco; Opioid Risk Tool\]
  • * Having ever experienced an overdose
  • * Current major medical problem \[e.g. mod-severe liver disease, pancreatitis, chronic pulmonary disease, untreated sleep apnea, hospitalized for an acute medical issue in the past 6 months\]
  • * Response to Brief Pain Iinventory Item 8 \<30%, suggesting less than moderately clinically 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 \[self-report\]: 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 \[open answer\]
  • * 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 BCI intervention;
  • * Severe medical condition (e.g. malignancy), likely to limit life expectancy or study participation;
  • * 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 of Long QT Syndrome.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Medical University of South Carolina,

Kelly Barth, PRINCIPAL_INVESTIGATOR, Medical University of South Carolina

Study Record Dates

2029-03-31