Stimulant Use DisorderPhase 1NCT06790576
Optimizing Transcranial Magnetic Stimulation for Stimulant Use Disorder
A Phase 1 study testing closed-loop-peak, Open-loop and closed-loop-trough in people with Stimulant Use Disorder, run by University of Minnesota at 1 site in United States.
Trial summary
The study will recruit 50 adults with stimulant use disorder currently in treatment and abstinent for at least 2 weeks. The study will also recruit up to 10 healthy controls (adults without StUD) for initial study configuration. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stimulant Use Disorder
- What is being tested?
- closed-loop-peak, Open-loop and closed-loop-trough
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2024to 1 Dec 2026
- Phase
- Phase 1
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Ability to provide consent and comply with all study procedures.
- Meets Diagnostic and Statistical Manual of Mental Disorders criteria for StUD (As assessed by MINI and self-report; Participants may have current comorbid drug use, but primary diagnosis must be StUD; does not apply to healthy control participants).
- At least 2 weeks of abstinence from substance use (other than caffeine or nicotine).
- Intention to remain in an addiction treatment program until intervention completion (does not apply to healthy control participants).
- Confident level of English language proficiency.
Who cannot join
- Any organic brain disorder (e.g. TBI, stroke).
- Head injury resulting in skull fracture or loss of consciousness exceeding 30 minutes.
- TMS contraindication (history of seizures, metallic cranial plates/screws or implanted device).
- MRI contraindications (unapproved metallic implants, pacemakers or any other implanted electrical device, shrapnel, metallic braces, non-removable body piercings, pregnancy, breathing or movement disorder, claustrophobia).
- Any psychotic disorder (Participants with other treated and stable psychiatric disorders will be included).
- Presence of a condition that would render study measures impossible to administer or interpret.
Show all 9Show fewer
- Primary current substance use disorder diagnosis on a substance other than stimulants or cocaine, except for caffeine or nicotine.
- Greater than 9 months abstinence from substance use (does not apply to healthy control participants).
- Pregnancy or breastfeeding.
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
University of Minnesota
Minneapolis, Minnesota, 55414
Melanie Martie, 612-301-2449, stima011@umn.edu
About this study
The study will recruit 50 adults with stimulant use disorder currently in treatment and abstinent for at least 2 weeks. The study will also recruit up to 10 healthy controls (adults without StUD) for initial study configuration. The study will consist of five steps that are expected to be completed over two lab visits.
Step 1: The 3T MRI scan will provide accurate prefrontal cortex anatomy for using neuronavigation for TMS. In addition, the study will use an analysis of resting fMRI connectivity to determine the location in the left DLPFC that has the maximum connectivity with the incentive-salience network.
Read more
Step 2: The study will use the data collected at the MRI to select the individual TMS location. EEG will be used to collect TEPs in response to single pulse TMS at the left DLPFC. Participants will then be randomized to one of three conditions: A) TMS unsynchronized with EEG, B) TMS synchronized with EEG theta frequency trough, and C) TMS synchronized with EEG theta frequency peak. The stimulation will be applied with an intensity of up to 120% of the resting motor threshold (which is a safe and common practice; Rossi et al., 2021). The intensity can be decreased for individual participants.
Step 3: Following randomization, the study will administer a pre-iTBS assessment.
Step 4: The study will compare brain and behavioral responses before and after the iTBS session with TMS and EEG synchronization as assigned by their randomized group.
Step 5: The study will administer a post-iTBS assessment.
- Conditions
- Stimulant Use Disorder
- Being tested
- closed-loop-peak, Open-loop, closed-loop-trough
- Keywords
- TMS, MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
closed-loop-peakOther
With single pulse TMS stimulation at F3 based on 10-20 EEG system, TMS evoked potentials (TEPs) will be collected under three TMS synchronization conditions: closed-loop-peak (each pulse synchronized to person's peak of theta waveform)
Open-loopOther
With single pulse TMS stimulation at F3 based on 10-20 EEG system, TMS evoked potentials (TEPs) will be collected under three TMS synchronization conditions: open-loop (TMS pulse delivered without regard to EEG)
closed-loop-troughOther
With single pulse TMS stimulation at F3 based on 10-20 EEG system, TMS evoked potentials (TEPs) will be collected under three TMS synchronization conditions: closed-loop-trough (each pulse synchronized to trough of theta waveform)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Participants assigned to closed-loop-peak Receives: Other: closed-loop-peak |
| Group 2 | Experimental | Participants assigned to open-loop Receives: Other: Open-loop |
| Group 3 | Experimental | Participants assigned to closed-loop-trough Receives: Other: closed-loop-trough |
What is being measured
The primary outcome is the main question the study is designed to answer.
TEP individual response
Use TMS-evoked potentials (TEPs) to assess individual response to three TMS-EEG synchronization methods: random, peak, and trough.
Measured: 2 hours
Cognitive response
Investigate the CSST task cognitive response to three TMS-EEG synchronization approaches during intermittent Theta Burst Stimulation (iTBS).
Measured: Measured immediately after the iTBS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start1 Dec 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (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.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three randomized groups for type of TMS stimulation (random, peak, and trough), triple-blinded
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Optiz, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06790576
- Sponsor's protocol ID
- PSYCH-2024-32713
- Status last verified
- Aug 2026
- First submitted
- 2 Jan 2025
- Last updated
- 1 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Transcranial Magnetic Stimulation for Stimulant Use Disorder
- ClinicalTrials.gov ID
- NCT06790576
- Acronym / sponsor ID
- PSYCH-2024-32713
- Conditions
- Stimulant Use Disorder
- Keywords
- TMS, MRI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 24 Jan 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 study will recruit 50 adults with stimulant use disorder currently in treatment and abstinent for at least 2 weeks. The study will also recruit up to 10 healthy controls (adults without StUD) for initial study configuration. The study will consist of five steps that are expected to be completed over two lab visits.
Step 1: The 3T MRI scan will provide accurate prefrontal cortex anatomy for using neuronavigation for TMS. In addition, the study will use an analysis of resting fMRI connectivity to determine the location in the left DLPFC that has the maximum connectivity with the incentive-salience network.
Step 2: The study will use the data collected at the MRI to select the individual TMS location. EEG will be used to collect TEPs in response to single pulse TMS at the left DLPFC. Participants will then be randomized to one of three conditions: A) TMS unsynchronized with EEG, B) TMS synchronized with EEG theta frequency trough, and C) TMS synchronized with EEG theta frequency peak. The stimulation will be applied with an intensity of up to 120% of the resting motor threshold (which is a safe and common practice; Rossi et al., 2021). The intensity can be decreased for individual participants.
Step 3: Following randomization, the study will administer a pre-iTBS assessment.
Step 4: The study will compare brain and behavioral responses before and after the iTBS session with TMS and EEG synchronization as assigned by their randomized group.
Step 5: The study will administer a post-iTBS assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Three randomized groups for type of TMS stimulation (random, peak, and trough), triple-blinded
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: closed-loop-peakParticipants assigned to closed-loop-peak |
| Group 2 | Experimental | Other: Open-loopParticipants assigned to open-loop |
| Group 3 | Experimental | Other: closed-loop-troughParticipants assigned to closed-loop-trough |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 or older
- Ability to provide consent and comply with all study procedures.
- Meets Diagnostic and Statistical Manual of Mental Disorders criteria for StUD (As assessed by MINI and self-report; Participants may have current comorbid drug use, but primary diagnosis must be StUD; does not apply to healthy control participants).
- At least 2 weeks of abstinence from substance use (other than caffeine or nicotine).
- Intention to remain in an addiction treatment program until intervention completion (does not apply to healthy control participants).
Key exclusion criteria (9 listed)
- Any organic brain disorder (e.g. TBI, stroke).
- Head injury resulting in skull fracture or loss of consciousness exceeding 30 minutes.
- TMS contraindication (history of seizures, metallic cranial plates/screws or implanted device).
- MRI contraindications (unapproved metallic implants, pacemakers or any other implanted electrical device, shrapnel, metallic braces, non-removable body piercings, pregnancy, breathing or movement disorder, claustrophobia).
- Any psychotic disorder (Participants with other treated and stable psychiatric disorders will be included).
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 |
|---|---|---|
| closed-loop-peakWith single pulse TMS stimulation at F3 based on 10-20 EEG system, TMS evoked potentials (TEPs) will be collected under three TMS synchronization conditions: closed-loop-peak (each pulse synchronized to person's peak of theta waveform) | Other | Group 1 |
| Open-loopWith single pulse TMS stimulation at F3 based on 10-20 EEG system, TMS evoked potentials (TEPs) will be collected under three TMS synchronization conditions: open-loop (TMS pulse delivered without regard to EEG) | Other | Group 2 |
| closed-loop-troughWith single pulse TMS stimulation at F3 based on 10-20 EEG system, TMS evoked potentials (TEPs) will be collected under three TMS synchronization conditions: closed-loop-trough (each pulse synchronized to trough of theta waveform) | Other | Group 3 |
Primary outcome
TEP individual response
Time frame: 2 hours
Use TMS-evoked potentials (TEPs) to assess individual response to three TMS-EEG synchronization methods: random, peak, and trough.
Cognitive response
Time frame: Measured immediately after the iTBS
Investigate the CSST task cognitive response to three TMS-EEG synchronization approaches during intermittent Theta Burst Stimulation (iTBS).
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 1 Sep 2026.
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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.
Alexander Optiz principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing closed-loop-peak, Open-loop and closed-loop-trough in people with Stimulant Use Disorder, run by University of Minnesota 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 6 inclusion and 9 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 1 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Melnie Martie (612-301-2449, stima011@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TEP individual response (time frame: 2 hours). The study lists 2 primary outcomes in all. 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 1 Sep 2026.