Individualized Neuromodulation of Craving Control for Meth Use Disorders

NCT06695637 | Withdrawn Early Phase 1

• 1 other identifier: PSYCH-2023-32513
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline, 24 hours

Secondary Outcomes (3)

• Change in Self-Reported Craving in Methamphetamine Use Disorder (MUD)

  baseline, 24 hours

• Baseline Connectivity Predicting Neural and Subjective Response to Individualized cTBS

  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

  baseline, 24 hours

Study Arms (2)

Study group

EXPERIMENTAL

Individuals diagnosed with MUDs randomized for study intervention

Radiation: active cTBS

Sham control group

SHAM COMPARATOR

Individuals diagnosed with MUDs randomized for sham intervention

Radiation: sham cTBS

Interventions

active cTBS RADIATION

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.

Study group

sham cTBS RADIATION

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.

Sham control group

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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
• 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.

Sponsors & Collaborators

• University of Minnesota: lead

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Kelvin Lim, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: November 19, 2024
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: December 17, 2025

Record last verified: 2025-12