Treating Stimulant Addiction With Repetitive Transcranial Magnetic Stimulation

NCT04228276 | Terminated Results FDA Device

• 2 other identifiers: D3314-P54458
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Stimulant Use Disorder; Substance-related Disorders

Keywords

Magnetic resonance imaging; Transcranial magnetic stimulation; Dopamine; Reward processing

Outcome Measures

Primary Outcomes (1)

• Number of Participants Relapsed

  Rate of stimulant use relapse compared between active vs. sham rTMS groups

  3 months after last rTMS treatment

Secondary Outcomes (1)

• Reward Circuit Function and Signaling

  Within 1 week before and after rTMS treatment

Study Arms (2)

Active rTMS

EXPERIMENTAL

Receive active rTMS

Device: Repetitive transcranial magnetic stimulation (rTMS)

Sham rTMS

SHAM COMPARATOR

Receive sham rTMS

Device: Repetitive transcranial magnetic stimulation (rTMS)

Interventions

Repetitive transcranial magnetic stimulation (rTMS) DEVICE

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.

Active rTMS; Sham rTMS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Stanford University: collaborator

Study Sites (1)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1207, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Limitations and Caveats

COVID-19 pandemic adversely affected recruitment.

Results Point of Contact

• Title: Dr. Jong Yoon
• Organization: Palo Alto VA

jong.yoon@va.gov

6504935000

Study Officials

• Jong H. Yoon, MD

  VA Palo Alto Health Care System, Palo Alto, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to one of two groups to receive active or sham rTMS.

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: January 14, 2020
• Study Start: February 5, 2021
• Primary Completion: April 30, 2024
• Study Completion: June 1, 2024
• Last Updated: August 29, 2025
• Results First Posted: May 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)