rTMS as Add on Treatment for Substance Use Disorders
Launched by YALE UNIVERSITY · May 6, 2025
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is exploring a treatment called repetitive Transcranial Magnetic Stimulation (rTMS) to help people with Opioid Use Disorder (OUD) and Alcohol Use Disorder (AUD). The study aims to find out which type of rTMS works best and where it should be applied in the brain to help reduce drug and alcohol use after treatment. Researchers want to know if applying rTMS in two different ways to specific areas of the brain will be more effective for reducing opioid or alcohol use.
To participate in this study, individuals must be between 18 and 75 years old, able to understand and give consent in English, and currently receiving treatment for either alcohol or opioid use. However, there are some important health conditions that could exclude someone from joining, such as a history of certain neurological disorders or heart problems. Participants in the study can expect to undergo rTMS treatment over five days, and the trial is not yet recruiting, so it may take some time before enrollment begins. Overall, this study could provide valuable insights into new ways to support individuals struggling with substance use disorders.
Gender
ALL
Eligibility criteria
- 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
About Yale University
Yale University, a prestigious Ivy League institution located in New Haven, Connecticut, is renowned for its commitment to advancing medical research and clinical innovation. With a rich history of academic excellence and a robust infrastructure for scientific inquiry, Yale serves as a leading sponsor for clinical trials aimed at improving patient care and developing new therapeutic approaches. The university's multidisciplinary teams of researchers and clinicians collaborate to conduct rigorous and ethical studies, leveraging cutting-edge technologies and methodologies to address critical health challenges. Through its dedication to fostering an environment of inquiry and discovery, Yale University plays a pivotal role in translating research findings into clinical practice, ultimately enhancing health outcomes for diverse populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Hartford, Connecticut, United States
Patients applied
Trial Officials
Vaughn R Steele, PhD
Principal Investigator
Yale University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported