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

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.

Study Overview

• Status: Recruiting
• Conditions: Substance-related Disorders; Stimulant Use Disorder
• Intervention / Treatment: Device: Repetitive transcranial magnetic stimulation (rTMS)

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jong H Yoon, MD; Phone Number: (650) 493-5000; Email: jhyoon1@stanford.edu

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304-1207
      • Recruiting
      • VA Palo Alto Health Care System, Palo Alto, CA
      • Contact: Jong H Yoon, MD; Phone Number: 650-493-5000; Email: jhyoon1@stanford.edu
      • Principal Investigator: Jong H. Yoon, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active rTMS; Receive active rTMS	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 8 sessions across 2 weeks. The brain region targeted is the dorsolateral prefrontal cortex.
Sham Comparator: Sham rTMS; Receive sham rTMS	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 8 sessions across 2 weeks. The brain region targeted is the dorsolateral prefrontal cortex.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relapse rate	Rate of stimulant use relapse and duration of abstinence compared between active vs. sham rTMS groups	3 months after last rTMS treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occupational/role functioning	Occupational/role functioning and changes in functioning compared between active vs. sham rTMS groups	Within 1 week before rTMS treatment, midpoint during rTMS treatment, within 1 week after rTMS treatment, and 3 months following rTMS treatment
Rest/activity cycles	Actigraphy will be conducted to examine rest/activity cycles during and following rTMS treatment. Changes will be compared between active and sham rTMS groups, and correlated with improvements in SUD.	During 2-week rTMS treatment and for 1 month following treatment
Reward circuit function and signaling	Before and after treatment, participants will undergo 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 will be measured in an individual-subject, "native space" ROI 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 will be compared between active vs. sham rTMS groups	Within 1 week before and after rTMS treatment

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: Stanford University
• Investigators: Principal Investigator: Jong H. Yoon, MD, VA Palo Alto Health Care System, Palo Alto, CA

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2021
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: January 7, 2020
• First Submitted That Met QC Criteria: January 10, 2020
• First Posted (Actual): January 14, 2020

Study Record Updates

• Last Update Posted (Actual): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Magnetic resonance imaging; Transcranial magnetic stimulation; Dopamine; Reward processing
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: D3314-P; 54458 (Other Identifier: Stanford University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No