Individualized Neuromodulation of Craving Control for Meth Use Disorders

Launched by UNIVERSITY OF MINNESOTA · Nov 15, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to help people who struggle with methamphetamine use by targeting their cravings. Researchers want to see if a type of brain stimulation called continuous theta burst stimulation (cTBS) can help reduce cravings and improve recovery outcomes. The study will involve adults aged 22 to 65 who are currently living in a treatment center and have been substance-free for at least one week. A total of 40 participants will be involved, and they will be randomly assigned to either receive the active treatment or a placebo (a "sham" treatment that doesn’t have any real effect).

If you or someone you know is interested in participating, it's important to note that participants should plan to stay in their treatment program until the end of the study and must be able to provide consent. They should also meet certain health criteria, such as having a diagnosis of methamphetamine use disorder, while some individuals with other substance use issues may still be eligible. Participants will be escorted for brain scans and stimulation sessions, and they will receive support throughout the trial. However, there are specific health conditions that could exclude someone from participating, such as certain medical devices or a history of seizures. Overall, this study aims to find innovative ways to help people overcome their cravings and stay sober.

Gender

ALL

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.