Repetitive Transcranial Magnetic Stimulation Treatment of Stimulant Use Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2029-12-31

Brief Summary

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The purpose of this study is to establish a new treatment (repetitive transcranial stimulation (rTMS)) for Veterans with stimulant use disorder (SUD). Despite the large public health burden imposed by SUD, there is currently no FDA-approved or widely recognized effective somatic treatment. This placebo controlled study will test the effectiveness of rTMS in the treatment of SUD, and explore biomarkers that may guide patient selection for rTMS treatment and predict treatment response.

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Detailed Description

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Conditions

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Stimulant Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomly assigned to one of two groups to receive active or sham rTMS.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

This is a double-blind study in which participants, staff administering treatment, investigators, and outcome assessors are all masked to group assignments.

Study Groups

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Active rTMS

Receive active rTMS

Group Type EXPERIMENTAL

Repetitive transcranial magnetic stimulation (rTMS)

Intervention Type DEVICE

rTMS is a non-invasive procedure in which administering a transient magnetic field induces electrical currents in specific, targeted brain regions. The intervention (active and sham) will be administered in 30 sessions across 2 weeks. The brain region targeted is the dorsolateral prefrontal cortex.

Sham rTMS

Receive sham rTMS

Group Type SHAM_COMPARATOR

Sham rTMS

Intervention Type DEVICE

Subjects randomized to sham rTMS will undergo the same procedures on the same equipment as subjects assigned to active rTMS, but no active magnetic stimulation will be delivered.

Interventions

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Repetitive transcranial magnetic stimulation (rTMS)

rTMS is a non-invasive procedure in which administering a transient magnetic field induces electrical currents in specific, targeted brain regions. The intervention (active and sham) will be administered in 30 sessions across 2 weeks. The brain region targeted is the dorsolateral prefrontal cortex.

Intervention Type DEVICE

Sham rTMS

Subjects randomized to sham rTMS will undergo the same procedures on the same equipment as subjects assigned to active rTMS, but no active magnetic stimulation will be delivered.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Structured Clinical Interview for DSM Disorders (SCID) confirmed diagnosis of SUD, severe
* Last use of stimulants \>2 and \<8 weeks
* Stable medication regimen (no change in dose or agents between 2 weeks prior to the start of and throughout the treatment phase of the study)
* Stable medical health

Exclusion Criteria

* Pregnant or lactating female
* History of prior adverse reaction to TMS
* On medications thought to significantly lower seizure threshold, e.g. clozapine, chlorpromazine, clomipramine, and bupropion \> 400mg/day
* Seizure disorder or conditions known to substantially increase risk for seizures
* Implants or medical devices incompatible with TMS
* Acute or unstable chronic medical illness that would affect participation or compliance in the study, e.g. unstable angina
* Unstable psychiatric symptoms that precludes consistent participation in the study, e.g. active current suicidal intent or plan; severe psychosis
* Other substance use disorder not in remission
* Chronic or recurring Axis I psychotic disorders
* For subjects participating in fMRI scans, presence of ferromagnetic material in their body or taking DAergic medications

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No