Treating Stimulant Addiction With Repetitive Transcranial Magnetic Stimulation

Not Applicable

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Structured Clinical Interview for DSM Disorders (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, functional magnetic resonance imaging (fMRI) scans, and rTMS (no contraindications)
Intelligence Quotient (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

Primary Outcome Measures

Name	Time	Method
Number of Participants Relapsed	3 months after last rTMS treatment	Rate of stimulant use relapse compared between active vs. sham rTMS groups

Secondary Outcome Measures

Name	Time	Method
Reward Circuit Function and Signaling	Within 1 week before and after rTMS treatment	Before and after treatment, participants underwent functional magnetic resonance imaging (fMRI) imaging while completing the Monetary Incentive Delay Task, a validated probe of reward processing circuit function and dysfunction. Signaling in the substantia nigra measured in an individual-subject, "native space" region of interest approach as a marker of dopaminergic reward processing function, as well as in voxel-wise, whole-brain exploratory analyses. Changes in reward function and signaling compared between active vs. sham rTMS groups

Locations (1): VA Palo Alto Health Care System, Palo Alto, CA
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Palo Alto, California, United States
VA Palo Alto Health Care System, Palo Alto, CA
🇺🇸Palo Alto, California, United States