WithdrawnEarly Phase 1

Individualized Neuromodulation of Craving Control for Meth Use Disorders

Stopped: Key study staff left the university

0Started 2025-09-01

Plain-language 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).

Who can participate

Age range22 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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) * Presenc…

What they're measuring

Change in Connectivity between the Amygdala/Ventral Striatum and Frontopolar Cortex Measurement

Timeframe: baseline, 24 hours

Trial details

NCT IDNCT06695637

SponsorUniversity of Minnesota

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-09-01