Repetitive Transcranial Magnetic Stimulation Treatment of Stimulant Use Disorder (VA-StARTS)

VA Office of Research and Development

Status: Begins enrollment in 1 month

Conditions: Stimulant Use Disorder

Treatments: Device: Repetitive transcranial magnetic stimulation (rTMS); Device: Sham rTMS

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT07112105

RRD4-003-24W

1-I01-RD-000693-01-A2 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 106 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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106 participants in 2 patient groups

Active rTMS

Experimental group

Description:

Receive active rTMS

Treatment:

Device: Repetitive transcranial magnetic stimulation (rTMS)

Sham rTMS

Sham Comparator group

Description:

Receive sham rTMS

Treatment:

Device: Sham rTMS