RECRUITING

rTMS as Add on Treatment for Substance Use Disorders

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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?

Official Title

rTMS as Add on Treatment for Substance Use Disorders

Quick Facts

Study Start:2025-05-12

Study Completion:2026-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06963476

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.

Ages Eligible for Study:18 Years to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Vaughn R Steele, Ph.D.

CONTACT

860.545.7855

vaughn.steele@yale.edu

Principal Investigator

Vaughn R Steele, PhD

PRINCIPAL_INVESTIGATOR

Yale University

Study Locations (Sites)

Hartford Healthcare

Hartford, Connecticut, 06102

United States

Collaborators and Investigators

Sponsor: Yale University

Vaughn R Steele, PhD, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-12

Study Completion Date2026-05

Study Record Updates

Study Start Date2025-05-12

Study Completion Date2026-05

Terms related to this study

Additional Relevant MeSH Terms

Opioid Use
Alcohol Use Disorder