Clinical trial NCT06695637: Individualized Neuromodulation of Craving Control for Meth Use Disorders
Official title: Individualized Neuromodulation of Craving Control for Meth Use Disorders
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Substance Use Disorders
Methamphetamine Use Disorders
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2024-11-19
Enrollment: 40
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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).


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.

Primary outcomes:
measure: Change in Connectivity between the Amygdala/Ventral Striatum and Frontopolar Cortex Measurement
timeFrame: baseline, 24 hours
Secondary outcomes:
measure: Change in Self-Reported Craving in Methamphetamine Use Disorder (MUD)
timeFrame: baseline, 24 hours
measure: Baseline Connectivity Predicting Neural and Subjective Response to Individualized cTBS
timeFrame: baseline, 24hours
measure: 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
timeFrame: baseline, 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: University of Minnesota
name: Kelvin Lim, MD
role: PRINCIPAL_INVESTIGATOR
References: