NCT06963476

rTMS as Add on Treatment for Substance Use Disorders

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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?

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 the rTMS intervention; 3) retention of follow-up at the 4-week interval. Aim 2: To assess superiority of mPFC cTBS compared to l-dlPFC iTBS to reduce alcohol use in AUD patients post-treatment. Superiority will be assessed by evaluating 1) treatment engagement at the 4-week interval (e.g., number of prescribed AUD treatments addended); 2) reduction of drinks/day post-treatment, compared to pre-treatment; 3) reduction of heavy drinking days (e.g., \>5 drinks/day) post-treatment, compared to pre-treatment. Aim 3: To assess superiority of l-dlPFC iTBS to l-dlPFC cTBS to reduce opioid use in OUD patients post-treatment. Superiority will be assessed by evaluating 1) treatment engagement at the 4-week interval (e.g., number of prescribed OUD treatments addended); 2) reduction of opioids used post-treatment, compared to pre-treatment.

Conditions

• Opioid Use
• Alcohol Use Disorder

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	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.

Timeline

• Start date: 2025-05-12
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2025-05-09
• Last updated: 2025-06-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study