Treating Stimulant Addiction With Repetitive Transcranial Magnetic Stimulation

NCT ID: NCT04228276

Last Updated: 2025-08-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-05
• Study Completion Date: 2024-06-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Active rTMS

Receive active rTMS

Group Type: EXPERIMENTAL

Repetitive transcranial magnetic stimulation (rTMS)

Intervention Type: 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.

Sham rTMS

Receive sham rTMS

Group Type: SHAM_COMPARATOR

Repetitive transcranial magnetic stimulation (rTMS)

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: collaborator

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jong H. Yoon, MD

Role: PRINCIPAL_INVESTIGATOR

VA Palo Alto Health Care System, Palo Alto, CA

Locations

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

54458

Identifier Type: OTHER

Identifier Source: secondary_id

D3314-P

Identifier Type: -

Identifier Source: org_study_id