EICHORCondition: Opioid Use · Alcohol Use Disorder · Sponsor: Yale University
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This pilot study is designed to test feasibility and superiority of rTMS types and target locations for the optimal rTMS intervention for individuals seeking treatment for Alcohol Use Disorder (AUD) or Opioid Use Disorder (OUD). The critical questions this study seeks to answer are: which rTMS type applied to l-dlPFC in OUD participants will induce the greatest reduction of opioid use post-treatment? Is inhibitory rTMS applied to medial prefrontal cortex (mPFC) more effective than excitatory rTMS applied to l-dlPFC at reducing alcohol use post treatment in AUD participants?
This description comes directly from the study's public registry record.
Vaughn R Steele, Ph.D. · 860.545.7855 · vaughn.steele@yale.edu
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Inclusion Criteria: * Be able to give valid informed consent in English. * Absence of cognitive impairment: IQ equivalent of ≥ 70 on the WRAT. * Receiving treatment for either AUD or OUD Exclusion Criteria: * History of any neurological disorder that would increase seizure risk from rTMS such as stroke, brain lesions, previous neurosurgery, any history of seizure or fainting episode of unknown cause, or head trauma resulting in loss of consciousness, lasting over 30 minutes or with sequela lasting longer than one month. * Current meeting withdrawal criteria for alcohol: AUD participants will not meet for clinically significant alcohol withdrawal: Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar) ≤ 5. * First-degree family history of epilepsy or multiple sclerosis. * Cardiac pacemakers, neural stimulators, implantable defibrillator, implanted medication pumps or sensors, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object in the body that precludes rTMS administration. * Current use of anti- or pro-convulsive action. * Use of benzodiazepines in the last 48 hours prior to rTMS. Benzodiazepines are used during alcohol withdrawal management but then are discontinued prior to recruitment into the study. Therefore, rTMS eligible participants will not continue taking benzodiazepines. * Lifetime history of schizophrenia, bipolar disorder, mania. * History of myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke, or transient ischemic attack. * Pregnant or lactating women. * TMS contraindications. * Treatment center discharge date does not allow for scheduling of all 5 rTMS days
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Hartford Healthcare | Hartford, Connecticut, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06963476