Using deep TMS to treat methamphetamine use disorder in veterans

Deep TMS Neuromodulation of Neural Circuits Associated With Stimulant Use Disorder

This study is testing if a new brain treatment called deep TMS can help veterans with methamphetamine use disorder reduce their cravings and avoid relapse.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 25 Years to 75 Years
• Sex: All
• Sponsor: Stanford University (other)
• Locations: 1 site (Palo Alto, California)
• Trial ID: NCT06578429 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of deep transcranial magnetic stimulation (dTMS) as a treatment for veterans suffering from methamphetamine use disorder (MUD). The approach involves targeting deeper brain regions to modulate neural circuits associated with addiction, aiming to improve treatment outcomes compared to traditional methods. Participants will receive either active dTMS or a sham treatment, with the goal of reducing cravings and relapse rates. The study leverages innovative H-coil designs to stimulate multiple brain networks, potentially enhancing neuroplasticity and recovery.

Who should consider this trial

Good fit: Ideal candidates are veterans aged 25-75 who meet the DSM-5 criteria for moderate to severe methamphetamine use disorder.

Not a fit: Patients with contraindications to transcranial magnetic stimulation or magnetic resonance imaging may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce cravings and relapse rates in veterans with methamphetamine use disorder.

How similar studies have performed: Previous studies using TMS for addiction have shown promising results, indicating that this approach may be effective, though this specific application of deep TMS is relatively novel.

Eligibility criteria

Inclusion:

* Must be within the age range of 25-75.
* Participants must meet Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for moderate to severe MUD (≥4 diagnostic symptoms).
* Participants must be able to obtain a Motor Threshold (MT), which will be determined during the screening process.
* Participants must have an adequately stable condition and environment to enable attendance at scheduled clinic visits.
* Participants must be able to read, verbalize, understand, and voluntarily sign the Informed Consent Form prior to participation in study procedures in English.
* If participants are on a medication regimen for comorbid symptoms, that regimen will be stable for the duration of the study and patient will be willing to remain on this regimen during the treatment phase.
* Participants must be fluent in English

Exclusion criteria:

* Transcranial magnetic stimulation (TMS) and magnetic resonance imaging (MRI) contraindications: such as a cardiac pacemaker, cochlear implant, or an implanted device (deep brain stimulation, ferromagnetic metal in the head and body, claustrophobia, pregnant or breastfeeding or other ferromagnetic device/object in the head and body within 30 cm of the treatment coil.
* General medical condition, disease, or neurological disorder that interferes with the assessments or participation.
* Unable to safely withdraw, at least two weeks prior to treatment, from medications that increase seizure risk.
* Current substance abuse as determined by positive toxicology screen
* Have a mass lesion, cerebral infarct, or other active CNS disease, including a seizure disorder.
* A recent suicide attempt (defined as within the last 30 days) or presence of current suicidal plan or intent. Patients at risk for suicide will be required to establish a written safety plan involving their primary therapist before entering the study.
* Severe impediment to vision, hearing and/or hand movement, as this is likely to interfere with the ability to follow study protocols.
* Greater than mild traumatic brain injury (defined as greater than 10 minutes loss of consciousness).
* Taking benzodiazepines or neuroleptic medications, or any medication known to alter seizure threshold.
* Acute or unstable chronic illness.
* Current or lifetime history of bipolar disorder or psychosis.
* Participation in another concurrent intervention-based clinical trial.

Where this trial is running

Palo Alto, California

• VA Palo Alto Health Care System — Palo Alto, California, United States (RECRUITING)

Study contacts

• Principal investigator: Claudia B Padula, PhD — Stanford University
• Study coordinator: Samantha Ward, BS

Conditions: Methamphetamine Use Disorder, Transcranial Magnetic Stimulation, Veterans, Deep Transcranial Magnetic Stimulation, Neuroimaging, Relapse