Status:
RECRUITING
rTMS as Add on Treatment for Substance Use Disorders
Lead Sponsor:
Yale University
Conditions:
Opioid Use
Alcohol Use Disorder
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
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) o...
Detailed Description
Aim 1: To assess feasibility of applying rTMS within a residential treatment center. Feasibility will be assessed by 1) recruitment of sufficient numbers of AUD and OUD participants; 2) completion of ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06963476
Start Date
May 12 2025
End Date
May 1 2026
Last Update
June 29 2025
Active Locations (1)
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1
Hartford Healthcare
Hartford, Connecticut, United States, 06102