rTMS as Add on Treatment for Substance Use Disorders

NCT06963476 | Recruiting FDA Device

• 2 other identifiers: Steele 042225HHC-2025-0073
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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) 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?

Conditions

Opioid Use; Alcohol Use Disorder

Outcome Measures

Primary Outcomes (4)

• Number of participants that successfully complete the study

  Successful completion of the study is defined as completing the rTMS protocol and the 4-week post-treatment follow-up.

  4-weeks post-treatment

• Mean number of drinks per day

  A timeline follow-back will be used to assess number of drinks per day.

  4-weeks post-treatment

• Mean number of heavy drinking days

  A timeline follow-back will be used to assess number of heavy drinking days.

  4-weeks post-treatment

• Opioid use

  A timeline follow-back will be used to assess the quantity of opioids used in bags.

  4-weeks post-treatment

Study Arms (2)

AUD

EXPERIMENTAL

Individuals receiving treatment from HHC for AUD. Participants will be asked to complete a battery of tasks at the prior to the first rTMS session and after the last rTMS session. Each rTMS eligible participant will be scheduled for 5 rTMS visits (to be completed within 2 weeks from start to finish). Each rTMS session will start with finding motor hotspot, the rTMS dose, then application of rTMS. Within AUD participants, random assignment of rTMS site (cTBS at mPFC vs iTBS at l-dlPFC) will occur in sets of 6 thus increasing rTMS site distribution even if a small sample is collected.

Device: repetitive transcranial magnetic stimulation (rTMS) for AUD

OUD

EXPERIMENTAL

Individuals receiving treatment from HHC for OUD. Participants will be asked to complete a battery of tasks at the prior to the first rTMS session and after the last rTMS session. Each rTMS eligible participant will be scheduled for 5 rTMS visits (to be completed within 2 weeks from start to finish). Each rTMS session will start with finding motor hotspot, the rTMS dose, then application of rTMS. Within OUD participants, random assignment of rTMS type (cTBS vs iTBS ) applied to l-dlPFC will occur in sets of 6 thus increasing rTMS site distribution even if a small sample is collected.

Device: repetitive transcranial magnetic stimulation (rTMS) for OUD

Interventions

repetitive transcranial magnetic stimulation (rTMS) for AUD DEVICE

Transcranial magnetic stimulation (TMS) is a noninvasive form of brain stimulation in which a changing magnetic field is used to cause electric current at a specific area of the brain through electromagnetic induction. To administer TMS, a stimulator equipped with a figure-8 coil will be used. Two separate coils will be used that are similar in appearance and acoustic properties. One active, unblinded, coil will be used to determine resting motor threshold (RMT) and deliver pulses for the recruitment curves; the other coil will be used to deliver rTMS. rTMS stimulation will be targeted using standard EEG electrode locations: FP1 for mPFC and F3 for l-dlPFC.

AUD

repetitive transcranial magnetic stimulation (rTMS) for OUD DEVICE

Description: Transcranial magnetic stimulation (TMS) is a noninvasive form of brain stimulation in which a changing magnetic field is used to cause electric current at a specific area of the brain through electromagnetic induction. To administer TMS, a stimulator equipped with a figure-8 coil will be used. Two separate coils will be used that are similar in appearance and acoustic properties. One active, unblinded, coil will be used to determine resting motor threshold (RMT) and deliver pulses for the recruitment curves; the other coil will be used to deliver rTMS. rTMS stimulation will be targeted using standard EEG electrode location F3 for l-dlPFC.

OUD

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Hartford Healthcare

Hartford, Connecticut, 06102, United States

RECRUITING

MeSH Terms

Conditions

Alcoholism

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Vaughn R Steele, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vaughn R Steele, Ph.D.

CONTACT

860.545.7855; vaughn.steele@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Individuals receiving treatment from Hartford Health Care (HHC) for AUD or OUD will be recruited.

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 9, 2025
• Study Start: May 12, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)