NCT06695637

Individualized Neuromodulation of Craving Control for Meth Use Disorders

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 22 Years – 65 Years
• Healthy volunteers: Not accepted

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. 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).

Conditions

• Substance Use Disorders
• Methamphetamine Use Disorders

Interventions

Type	Name	Description
RADIATION	active 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.
RADIATION	sham 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.

Timeline

• Start date: 2025-09-01
• Primary completion: 2029-09-01
• Completion: 2029-09-01
• First posted: 2024-11-19
• Last updated: 2025-12-17