Substance Use DisordersEarly Phase 1NCT06695637
Individualized Neuromodulation of Craving Control for Meth Use Disorders
A Early Phase 1 study testing active cTBS in people with Substance Use Disorders and Methamphetamine Use Disorders, run by University of Minnesota.
Trial summary
Drug craving is one of the key aspects of substance use disorders (SUDs) and is associated with continued drug use and relapse. Approximately 70% of those entering treatment will relapse within one year. Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Substance Use Disorders, Methamphetamine Use Disorders
- What is being tested?
- active cTBS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Sep 2029
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Abstinent from any substance or alcohol use (excluding caffeine or nicotine) for a minimum of 1 week at study enrollment
- Has the intention to remain in their treatment program(s) until the end of the intervention portion of the study.
- Able to provide written consent and comply with study procedures.
- Meets the DSM-V MINI diagnostic criteria for methamphetamine use disorder (MUD).
- Subjects may have current comorbid drug use, but one of their major substance use disorder diagnosis needs to be methamphetamine use. Potential subjects will not be excluded for being on medication-assisted treatments (MATs), such as those used to treat substance use disorders.
Who cannot join
- Any contraindications for MRI scanning (up to the discretion of MIDB staff:
- metal implants, pacemakers or any other implanted electrical device, injury with metal, braces, dental implants, non-removable body piercings, pregnancy, breathing or moving disorder, moderate to severe heart disease).
- Any medical condition or treatment with neurological sequelae (i.e., stroke, tumor, HIV, intracranial lesions)
- Having epilepsy, a personal history of a seizure (beyond fever or withdrawal or medical induced seizure), or individuals with a family history of clinically proven epilepsy disorder in a first degree relative
- Over 9 months of abstinence from substance use
- A head injury resulting in a loss of consciousness exceeding 30 minutes (i.e., moderate or severe TBI)
Show all 14Show fewer
- Presence of a condition that would render study measures difficult or impossible to administer or interpret
- Age outside the range of 22 to 65
- Entrance to the treatment program under a court mandate. (i.e., legally incarcerated)
- History of ECT or cortical energy exposure within the past 6 months, including participation in any other neuromodulation studies
- Being pregnant. For females of reproductive potential: negative pregnancy test or use of highly effective contraception for at least 1 month prior to baseline will be necessary for inclusion.
- Having current active suicidal ideations reported in baseline psychiatry interview
- Having active bipolar disorder (with a risk of mania)
- Using medications that significantly increase risk of seizure for this study based on the clinical judgement of the study's medical team such as immediate release bupropion (Wellbutrin IR), stimulants, and tramadol.
About this study
Drug craving is one of the key aspects of substance use disorders (SUDs) and is associated with continued drug use and relapse. Approximately 70% of those entering treatment will relapse within one year. To improve treatment outcomes, new interventions targeting the underlying brain biomarkers of relapse vulnerability hold significant promise in reducing this critical public health problem.
This clinical trial is designed as a randomized, double-blind, sham-controlled study, aiming to investigate the effects of continuous theta burst stimulation (cTBS) on individuals diagnosed with Methamphetamine Use Disorders (MUDs). Only adults (22-65 years old) who are already living in an abstinence-based residential setting for substance use treatment will be recruited, and participants will be escorted to and from the MIDB center for their imaging and brain stimulation sessions. After a baseline assessment to determine eligibility, the study will include 40 participants, who will be randomly assigned to two groups: the active cTBS group and the sham cTBS group (a control group receiving a placebo treatment).
- Being tested
- active cTBS, sham cTBS
- 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.
active cTBSRadiation
Transcranial Magnetic Stimulation (TMS) is a non-invasive neuromodulation technique which employs magnetic fields to stimulate neural activity in the brain. cTBS is a specific TMS protocol, wherein bursts of high-frequency magnetic pulses are repeatedly applied in a rhythmic pattern, mimicking the theta rhythm of neural oscillations. Studies suggest that cTBS has the potential to modulate cortical excitability and synaptic plasticity, leading to alterations in targeted brain function.
Baseline measures will be collected to develop individualized targets for stimulation and also understand how brain structure and activity may change in response to cTBS.
sham cTBSRadiation
The intervention group receives cTBS and the control group receives sham stimulation using the sham option in the coil that makes the same noise and feeling without delivering significant amount of magnetic energy into the brain. Both groups are exposed to drug and neutral pictures before and after receiving stimulation. People in the active group will receive cTBS with corrected individualized stimulation intensity to have 1 V/m in targeted brain regions while in the sham group people will only receive sham condition with a similar look, sound, and feel of active stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Individuals diagnosed with MUDs randomized for study intervention Receives: Radiation: active cTBS |
| Sham control group | Sham comparator | Individuals diagnosed with MUDs randomized for sham intervention Receives: Radiation: sham cTBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Connectivity between the Amygdala/Ventral Striatum and Frontopolar Cortex Measurement
Connectivity strength between the amygdala/ventral striatum and frontopolar cortex, measured by generalized psychophysiological interaction (gPPI) analysis.
Measurement Tool: Connectivity strength measured using fMRI-based gPPI with Brainnetome atlas parcellation.
Unit of Measure: Regression coefficient representing connectivity strength.
Measured: baseline, 24 hours
Secondary outcomes (3)
Change in Self-Reported Craving in Methamphetamine Use Disorder (MUD)
Self-reported craving levels in response to continuous theta-burst stimulation (cTBS).
Measurement Tool: Craving levels assessed via a standardized self-report craving scale (e.g., Visual Analog Scale for Craving or other validated scale for substance use disorders).
Unit of Measure: Score change or percentage change from baseline on the craving scale.
Measured: baseline, 24 hours
Baseline Connectivity Predicting Neural and Subjective Response to Individualized cTBS
Baseline connectivity between the amygdala/ventral striatum and frontopolar cortex as a predictor of neural and subjective response to individualized cTBS.
Measurement Tool: Baseline connectivity measured using fMRI-based generalized psychophysiological interaction (gPPI) analysis with Brainnetome atlas parcellation; response measured by self-report craving scale and fMRI post-intervention.
Unit of Measure: Predictive accuracy for post-intervention craving scores (score change or percentage change) and neural activity (correlation coefficients).
Measured: baseline, 24hours
Predictive Role of Individualized Current Density in Prefrontal Cortex for Subjective and Neural Response to cTBS density in the head models in the prefrontal cortex in both subjective and neural response to cTBS
Outcome Measure Title/Description: Current density within the prefrontal cortex, estimated from individualized head models, as a predictor of subjective craving response and neural response following cTBS.
Measurement Tool: Current density calculated from structural MRI-based individualized head models, with predictive accuracy assessed through self-report craving scale scores and fMRI measures post-intervention.
Unit of Measure: Current density (A/m²) for neural prediction; craving response measured by score or percentage change on craving scale.
Measured: baseline, 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Sep 2029 (estimated)
Why it stopped: Key study staff left the university
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kelvin Lim, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06695637
- Sponsor's protocol ID
- PSYCH-2023-32513
- Status last verified
- Dec 2025
- First submitted
- 15 Oct 2024
- Last updated
- 17 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Neuromodulation of Craving Control for Meth Use Disorders
- ClinicalTrials.gov ID
- NCT06695637
- Acronym / sponsor ID
- PSYCH-2023-32513
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Key study staff left the university
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 19 Nov 2024 (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.
Drug craving is one of the key aspects of substance use disorders (SUDs) and is associated with continued drug use and relapse. Approximately 70% of those entering treatment will relapse within one year. To improve treatment outcomes, new interventions targeting the underlying brain biomarkers of relapse vulnerability hold significant promise in reducing this critical public health problem.
This clinical trial is designed as a randomized, double-blind, sham-controlled study, aiming to investigate the effects of continuous theta burst stimulation (cTBS) on individuals diagnosed with Methamphetamine Use Disorders (MUDs). Only adults (22-65 years old) who are already living in an abstinence-based residential setting for substance use treatment will be recruited, and participants will be escorted to and from the MIDB center for their imaging and brain stimulation sessions. After a baseline assessment to determine eligibility, the study will include 40 participants, who will be randomly assigned to two groups: the active cTBS group and the sham cTBS group (a control group receiving a placebo treatment).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Radiation: active cTBSIndividuals diagnosed with MUDs randomized for study intervention |
| Sham control group | Sham comparator | Radiation: sham cTBSIndividuals diagnosed with MUDs randomized for sham intervention |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Abstinent from any substance or alcohol use (excluding caffeine or nicotine) for a minimum of 1 week at study enrollment
- Has the intention to remain in their treatment program(s) until the end of the intervention portion of the study.
- Able to provide written consent and comply with study procedures.
- Meets the DSM-V MINI diagnostic criteria for methamphetamine use disorder (MUD).
- Subjects may have current comorbid drug use, but one of their major substance use disorder diagnosis needs to be methamphetamine use. Potential subjects will not be excluded for being on medication-assisted treatments (MATs), such as those used to treat substance use disorders.
Key exclusion criteria (14 listed)
- Any contraindications for MRI scanning (up to the discretion of MIDB staff:
- metal implants, pacemakers or any other implanted electrical device, injury with metal, braces, dental implants, non-removable body piercings, pregnancy, breathing or moving disorder, moderate to severe heart disease).
- Any medical condition or treatment with neurological sequelae (i.e., stroke, tumor, HIV, intracranial lesions)
- Having epilepsy, a personal history of a seizure (beyond fever or withdrawal or medical induced seizure), or individuals with a family history of clinically proven epilepsy disorder in a first degree relative
- Over 9 months of abstinence from substance use
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 |
|---|---|---|
| active cTBSTranscranial Magnetic Stimulation (TMS) is a non-invasive neuromodulation technique which employs magnetic fields to stimulate neural activity in the brain. cTBS is a specific TMS protocol, wherein bursts of high-frequency magnetic pulses are repeatedly applied in a rhythmic pattern, mimicking the theta rhythm of neural oscillations. Studies suggest that cTBS has the potential to modulate cortical excitability and synaptic plasticity, leading to alterations in targeted brain function. Baseline measures will be collected to develop individualized targets for stimulation and also understand how brain structure and activity may change in response to cTBS. | Radiation | Study group |
| sham cTBSThe intervention group receives cTBS and the control group receives sham stimulation using the sham option in the coil that makes the same noise and feeling without delivering significant amount of magnetic energy into the brain. Both groups are exposed to drug and neutral pictures before and after receiving stimulation. People in the active group will receive cTBS with corrected individualized stimulation intensity to have 1 V/m in targeted brain regions while in the sham group people will only receive sham condition with a similar look, sound, and feel of active stimulation. | Radiation | Sham control group |
Primary outcome
Change in Connectivity between the Amygdala/Ventral Striatum and Frontopolar Cortex Measurement
Time frame: baseline, 24 hours
Connectivity strength between the amygdala/ventral striatum and frontopolar cortex, measured by generalized psychophysiological interaction (gPPI) analysis. Measurement Tool: Connectivity strength measured using fMRI-based gPPI with Brainnetome atlas parcellation. Unit of Measure: Regression coefficient representing connectivity strength.
3 secondary outcomes
Change in Self-Reported Craving in Methamphetamine Use Disorder (MUD)
Time frame: baseline, 24 hours
Baseline Connectivity Predicting Neural and Subjective Response to Individualized cTBS
Time frame: baseline, 24hours
Predictive Role of Individualized Current Density in Prefrontal Cortex for Subjective and Neural Response to cTBS density in the head models in the prefrontal cortex in both subjective and neural response to cTBS
Time frame: baseline, 24 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
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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.
Kelvin Lim, MD principal investigator
University of Minnesota
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing active cTBS in people with Substance Use Disorders and Methamphetamine Use Disorders, run by University of Minnesota.
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 14 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: withdrawn, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in Connectivity between the Amygdala/Ventral Striatum and Frontopolar Cortex Measurement (time frame: baseline, 24 hours). 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 17 Dec 2025.