Stimulant Use DisorderVA-StARTSNCT07112105
Repetitive Transcranial Magnetic Stimulation Treatment of Stimulant Use Disorder
A study testing Repetitive transcranial magnetic stimulation (rTMS) in people with Stimulant Use Disorder, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stimulant Use Disorder
- What is being tested?
- Repetitive transcranial magnetic stimulation (rTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be a U.S. Veteran
- Structured Clinical Interview for DSM Disorders (SCID) confirmed diagnosis of SUD, severe
- Last use of stimulants >2 and <8 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 medical health
Who cannot join
- Pregnant or lactating female
- History of prior adverse reaction to Transcranial magnetic stimulation (TMS)
- On medications thought to significantly lower seizure threshold, e.g. clozapine, chlorpromazine, clomipramine, and bupropion > 400mg/day
- Seizure disorder 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 in the study, e.g. unstable angina
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- Unstable psychiatric symptoms that precludes consistent participation in the study, e.g. active current suicidal intent or plan; severe psychosis
- Other substance use disorder not in remission
- Chronic or recurring Axis I psychotic disorders
- For subjects participating in functional magnetic resonance imaging (fMRI) scans, presence of ferromagnetic material in their body or taking DAergic medications
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1207
Jong H Yoon, MD, (650) 493-5000, Jong.Yoon@va.gov
Jong H. Yoon, MD
About this study
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. This placebo controlled study will test the effectiveness 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
- Being tested
- Repetitive transcranial magnetic stimulation (rTMS), Sham rTMS
- Keywords
- Magnetic resonance imaging, Transcranial magnetic stimulation, Intermittent theta burst stimulation, Dopamine, Reward processing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 30 sessions across 2 weeks. The brain region targeted is the dorsolateral prefrontal cortex.
Sham rTMSDevice
Subjects randomized to sham rTMS will undergo the same procedures on the same equipment as subjects assigned to active rTMS, but no active magnetic stimulation will be delivered.
| Study group | Role | What they receive |
|---|---|---|
| Active rTMS | Experimental | Receive active rTMS Receives: Device: Repetitive transcranial magnetic stimulation (rTMS) |
| Sham rTMS | Sham comparator | Receive sham rTMS Receives: Device: Sham rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Relapsed
Rate of stimulant use relapse compared between active vs. sham rTMS groups
Measured: 3 months after last rTMS treatment
Secondary outcomes (1)
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" 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 will be compared between active vs. sham rTMS groups.
Measured: Within 1 week before rTMS treatment and within 1 week after rTMS treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start1 May 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stimulant Use DisorderStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two groups to receive active or sham rTMS.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Stanford University
- Responsible party
- Sponsor
- Investigators
- Jong H. Yoon, MD, Principal investigator, VA Palo Alto Health Care System, Palo Alto, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07112105
- Sponsor's protocol ID
- RRD4-003-24W
- Other IDs
- 1I01RD000693-01A2
- Acronym
- VA-StARTS
- Status last verified
- Sep 2026
- First submitted
- 25 Jul 2025
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation Treatment of Stimulant Use Disorder
- ClinicalTrials.gov ID
- NCT07112105
- Acronym / sponsor ID
- VA-StARTS / RRD4-003-24W
- Conditions
- Stimulant Use Disorder
- Keywords
- Magnetic resonance imaging, Transcranial magnetic stimulation, Intermittent theta burst stimulation, Dopamine, Reward processing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Stanford University
- Study start
- 1 May 2026 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. This placebo controlled study will test the effectiveness of rTMS in the treatment of SUD, and explore biomarkers that may guide patient selection for rTMS treatment and predict treatment response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two groups to receive active or sham rTMS.
| Arm | Type | Receives |
|---|---|---|
| Active rTMS | Experimental | Device: Repetitive transcranial magnetic stimulation (rTMS)Receive active rTMS |
| Sham rTMS | Sham comparator | Device: Sham rTMSReceive sham rTMS |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must be a U.S. Veteran
- Structured Clinical Interview for DSM Disorders (SCID) confirmed diagnosis of SUD, severe
- Last use of stimulants >2 and <8 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 medical health
Key exclusion criteria (10 listed)
- Pregnant or lactating female
- History of prior adverse reaction to Transcranial magnetic stimulation (TMS)
- On medications thought to significantly lower seizure threshold, e.g. clozapine, chlorpromazine, clomipramine, and bupropion > 400mg/day
- Seizure disorder or conditions known to substantially increase risk for seizures
- Implants or medical devices incompatible with TMS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 30 sessions across 2 weeks. The brain region targeted is the dorsolateral prefrontal cortex. | Device | Active rTMS |
| Sham rTMSSubjects randomized to sham rTMS will undergo the same procedures on the same equipment as subjects assigned to active rTMS, but no active magnetic stimulation will be delivered. | Device | Sham rTMS |
Primary outcome
Number of Participants Relapsed
Time frame: 3 months after last rTMS treatment
Rate of stimulant use relapse compared between active vs. sham rTMS groups
1 secondary outcome
Reward circuit function and signaling
Time frame: Within 1 week before rTMS treatment and within 1 week after rTMS treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jong H. Yoon, MD principal investigator
VA Palo Alto Health Care System, Palo Alto, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive transcranial magnetic stimulation (rTMS) in people with Stimulant Use Disorder, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jong H Yoon, MD ((650) 493-5000, Jong.Yoon@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Relapsed (time frame: 3 months after last rTMS treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.