Phase
Condition
Chronic Pain
Pain
Treatment
Sham Transcranial Magnetic Stimulation (TMS)
Transcranial Magnetic Stimulation (TMS)
Placebo
Clinical Study ID
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
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
Study Description
Connect with a study center
Medical University of South Carolina
Charleston, South Carolina 29407
United StatesActive - Recruiting
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