An Early Phase 1 interventional study of active cTBS and sham cTBS in Substance Use Disorders and Methamphetamine Use Disorders, sponsored by University of Minnesota. Withdrawn. Open to participants aged 22 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-12-17.
Sponsored by University of Minnesota · Early Phase 1, Interventional, and Basic science
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).
2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.
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Exclusion Criteria:
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).
Individuals diagnosed with MUDs randomized for study intervention
Radiation: active cTBS
Individuals diagnosed with MUDs randomized for sham intervention
Radiation: sham cTBS
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.
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.
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.
Time frame: baseline, 24 hours
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.
Time frame: 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).
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
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.
Time frame: baseline, 24 hours
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This study is withdrawn, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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University of Minnesota