Stimulant Use DisorderVA-StARTSNCT04228276
Treating Stimulant Addiction With Repetitive Transcranial Magnetic Stimulation
A study testing Repetitive transcranial magnetic stimulation (rTMS) in people with Stimulant Use Disorder and Substance-related Disorders, 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, Substance-related Disorders
- 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
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2021to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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
Who cannot join
- Pregnant or lactating female
- History of prior adverse reaction to TMS
- On medications thought to significantly lower seizure threshold, e.g.:
- clozapine
- chlorpromazine
- clomipramine
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1207
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. 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.
- Being tested
- Repetitive transcranial magnetic stimulation (rTMS)
- Keywords
- Magnetic resonance imaging, Transcranial magnetic stimulation, Dopamine, Reward processing
- Medical subject headings
- Substance-Related Disorders
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 8 sessions across 2 weeks. The brain region targeted is the dorsolateral prefrontal cortex.
| 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: Repetitive transcranial magnetic stimulation (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 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
Measured: Within 1 week before and 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 posted14 Jan 2020
- Study start5 Feb 2021
- Primary completion30 Apr 2024
- Study completion1 Jun 2024
Why it stopped: COVID-19 pandemic adversely affected recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
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
- NCT04228276
- Sponsor's protocol ID
- D3314-P
- Other IDs
- 54458
- Acronym
- VA-StARTS
- Status last verified
- Aug 2025
- First submitted
- 7 Jan 2020
- Last updated
- 29 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Stimulant Addiction With Repetitive Transcranial Magnetic Stimulation
- ClinicalTrials.gov ID
- NCT04228276
- Acronym / sponsor ID
- VA-StARTS / D3314-P
- Keywords
- Magnetic resonance imaging, Transcranial magnetic stimulation, Dopamine, Reward processing
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 pandemic adversely affected recruitment.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Stanford University
- Study start
- 5 Feb 2021 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 14 Jan 2020 (actual)
- Results
- Posted 15 May 2025
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. 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- 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: Repetitive transcranial magnetic stimulation (rTMS)Receive sham rTMS |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (17 listed)
- Pregnant or lactating female
- History of prior adverse reaction to TMS
- On medications thought to significantly lower seizure threshold, e.g.:
- Use of direct dopaminergic antagonists or agonists
- History of seizures or conditions known to substantially increase risk for seizures
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 8 sessions across 2 weeks. The brain region targeted is the dorsolateral prefrontal cortex. | Device | Active rTMS, 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 and after rTMS treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
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 and Substance-related Disorders, 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 8 inclusion and 17 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: stopped early, as of the sponsor's last update on 29 Aug 2025. 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?
Yes. Results are posted in the registry (first posted 15 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 29 Aug 2025.