Recruiting

rTMS

Sponsor:

Yale University

Code:

NCT06963476

Conditions

Opioid Use

Alcohol Use Disorder

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

repetitive transcranial magnetic stimulation (rTMS) for AUD

repetitive transcranial magnetic stimulation (rTMS) for OUD

Study Details

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

Study ID

NCT06963476

Start date

May 12, 2025

Status verified date

Jun, 2025

Completion date

May, 2026

Anticipated

Primary completion date

May, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: AUD

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.

experimental: OUD

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.

Interventions

repetitive transcranial magnetic stimulation (rTMS) for AUD

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.

repetitive transcranial magnetic stimulation (rTMS) for OUD

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.

Primary outcome measure

  • Number of participants that successfully complete the study [ Time Frame: 4-weeks post-treatment ]
  • Mean number of drinks per day [ Time Frame: 4-weeks post-treatment ]
  • Mean number of heavy drinking days [ Time Frame: 4-weeks post-treatment ]
  • Opioid use [ Time Frame: 4-weeks post-treatment ]

Central Contacts and Locations

Central contacts

Vaughn R Steele, Ph.D.

860.545.7855vaughn.steele@yale.edu

Locations

Hartford Healthcare

Recruiting

Hartford, Connecticut, United States, 06102

More Information

Sponsor

Yale University

Last update posted

Jun 29, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2025-06-29.