Treating Stimulant Addiction With Repetitive Transcranial Magnetic Stimulation (VA-StARTS)

VA Office of Research and Development

Status: Enrolling

Conditions: Stimulant Use Disorder; Substance-related Disorders

Treatments: Device: Repetitive transcranial magnetic stimulation (rTMS)

Study type: Interventional

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

Identifiers

NCT04228276

54458 (Other Identifier)

D3314-P

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. rTMS may be a promising treatment option for SUD. In this study, we will demonstrate the feasibility of applying rTMS to Veterans with SUD, examine the efficacy of rTMS in the treatment of SUD, and explore biomarkers that may guide patient selection for rTMS treatment and predict treatment response.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• SCID confirmed diagnosis of SUD, severe
• Last use of stimulants >1 and <6 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 social environment and housing to enable regular attendance at clinic visits.
• Ability to undergo cognitive testing, fMRI scans, and rTMS (no contraindications)
• IQ > 80
• Stable medical health
• Veteran at Palo Alto VA's Addiction Treatment Services

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
  • bupropion > 400 mg/day

• Use of direct dopaminergic antagonists or agonists

• History of seizures 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 with study procedures, e.g. unstable angina

• Unstable psychiatric symptoms that precludes consistent participation in the study, e.g.:

  • active current suicidal intent or plan
  • severe psychosis

• Inability to undergo fMRI scan, e.g. claustrophobia, presence of ferromagnetic objects in subject's body

• Other substance use disorder not in sustained remission

• Chronic or recurring Axis I psychiatric condition preceding SUD other than PTSD

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 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: Repetitive transcranial magnetic stimulation (rTMS)