Individualized Neuromodulation of Craving Control for Meth Use Disorders

NCT ID: NCT06695637

Last Updated: 2025-12-17

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: EARLY_PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2029-09-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Study group

Individuals diagnosed with MUDs randomized for study intervention

Group Type: EXPERIMENTAL

active cTBS

Intervention Type: 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.

Sham control group

Individuals diagnosed with MUDs randomized for sham intervention

Group Type: SHAM_COMPARATOR

sham cTBS

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: RADIATION

Eligibility Criteria

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)
• 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
• Being pregnant. For females of reproductive potential: negative pregnancy test or use of highly effective contraception for at least 1 month prior to baseline will be necessary for inclusion.
• 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.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kelvin Lim, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Other Identifiers

PSYCH-2023-32513

Identifier Type: -

Identifier Source: org_study_id