Researchers have initiated a randomized clinical trial protocol to investigate an accelerated brain stimulation regimen for people diagnosed with moderate to severe methamphetamine use disorder. The study protocol, published in the journal Addiction Science & Clinical Practice, outlines an investigation evaluating the safety, feasibility, and preliminary efficacy of accelerated intermittent theta-burst stimulation. Methamphetamine use disorder is associated with elevated mortality rates and substantial societal costs, while no pharmacological treatment currently holds approval from the United States Food and Drug Administration or has demonstrated consistent clinical efficacy.
Emerging research indicates that transcranial magnetic stimulation targeting neural circuitry involved in cognitive control, incentive salience, craving, and reward processing may offer therapeutic benefits. To evaluate this intervention in a targeted manner, the trial focuses specifically on applying intermittent theta-burst stimulation over the left dorsolateral prefrontal cortex. Investigators aim to determine whether delivering repetitive bursts of stimulation to this cortical region can be administered safely while assessing initial signals of clinical improvement in individuals experiencing substantial stimulant dependence.
The study is structured as a single-site, randomized, double-blind, sham-controlled pilot trial seeking to enroll 20 adult participants. Those randomized will be assigned in an equal one-to-one ratio to receive either active intermittent theta-burst stimulation or an inactive sham procedure.
Eligible individuals will be admitted to an inpatient research unit to undergo an intensive treatment schedule consisting of up to 40 intermittent theta-burst stimulation or sham sessions delivered across five consecutive days. Following completion of the five-day hospital stay, any participant who receives at least one transcranial magnetic stimulation session will transition to an outpatient phase with weekly follow-up assessments lasting for 12 weeks.
The primary outcomes of the investigation focus on establishing the safety, tolerability, and feasibility of administering the accelerated stimulation schedule during inpatient admission. Secondary outcomes track clinical course over time, measuring ongoing methamphetamine use through weekly urine drug screens alongside the Timeline Follow-Back assessment method. Secondary endpoints also quantify changes in stimulant craving utilizing both the Stimulant Craving Questionnaire-Brief and standard visual analog scales.
In addition to behavioral and clinical metrics, the protocol incorporates exploratory magnetic resonance imaging measures to observe underlying neural mechanisms. Investigators plan to assess pre-treatment to post-treatment changes in cue-elicited craving responses during functional scanning, as well as alterations in resting-state functional connectivity networks.
The trial is registered under the ClinicalTrials.gov identifier NCT06320366, with an initial registration date of March 13, 2024, and protocol version documentation dated July 8, 2025.
Investigators emphasize that the current work represents a pilot evaluation rather than definitive evidence of clinical efficacy. If the accelerated intermittent theta-burst stimulation protocol demonstrates adequate tolerability and operational feasibility alongside positive preliminary trends, the findings are intended to justify larger, adequately powered clinical trials. The researchers note that a short-stay, accelerated intervention model could ultimately offer a scalable approach to neuromodulation, bridging the therapeutic transition between residential inpatient programs and standard outpatient addiction care.
Subject of Research: Clinical trial protocol evaluating accelerated intermittent theta-burst stimulation for methamphetamine use disorder
Article Title: Testing an accelerated transcranial magnetic stimulation protocol for methamphetamine use disorder — study protocol
Article References: Ramirez, D., Tanabe, J., Mikulich-Gilbertson, S. K., Winters, D., Fenstermacher, E., Raymond, K., Gebhardt, H., & Sakai, J. (2026). Testing an accelerated transcranial magnetic stimulation protocol for methamphetamine use disorder — study protocol. Addiction Science & Clinical Practice. https://doi.org/10.1186/s13722-026-00742-7
Image Credits: AI Generated
DOI: 10.1186/s13722-026-00742-7
Keywords: methamphetamine use disorder, transcranial magnetic stimulation, intermittent theta-burst stimulation, left dorsolateral prefrontal cortex, pilot clinical trial, double-blind study, sham-controlled trial, inpatient research, stimulant craving, urine drug screens, Timeline Follow-Back, resting-state networks, magnetic resonance imaging, neuromodulation, safety and feasibility, addiction science
News Source: Ophelia Keating. (November 13, 2026). Clinical Trial Tests Accelerated Brain Stimulation Protocol for Methamphetamine Use Disorder. Scienmag.
