Repetitive Transcranial Magnetic Stimulation Treatment of Stimulant Use Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Repetitive transcranial magnetic stimulation (rTMS), Sham rTMS.
- Who it may be relevant to
- Registry conditions: Stimulant Use Disorder. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device 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. - 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.
Primary outcome measures
- Number of Participants Relapsed [Time frame: 3 months after last rTMS treatment]
Secondary outcome measures (1)
- Reward circuit function and signaling [Time frame: Within 1 week before rTMS treatment and within 1 week after rTMS treatment]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- VA Palo Alto Health Care System, Palo Alto, CA — Palo Alto
Identifiers
NCT: NCT07112105 · RRD4-003-24W · 1I01RD000693-01A2