Accelerated TMS for treating methamphetamine use disorder

Testing an Accelerated TMS Protocol for Methamphetamine Use Disorder

This study is testing a new fast treatment using brain stimulation to see if it can help people with moderate to severe methamphetamine use disorder.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 21 Years to 65 Years
• Sex: All
• Sponsor: University of Colorado, Denver (other)
• Locations: 1 site (Aurora, Colorado)
• Trial ID: NCT06320366 on ClinicalTrials.gov

What this trial studies

This study evaluates the effects of an accelerated Transcranial Magnetic Stimulation (TMS) protocol targeting the left dorsolateral prefrontal cortex in individuals with moderate to severe methamphetamine use disorder. It employs a randomized double-blind sham-controlled design with 20 participants receiving either active or sham TMS over a 5-day inpatient stay. The study aims to assess feasibility, safety, and efficacy, as well as to identify changes in brain activity through magnetic resonance imaging before and after treatment, with follow-up assessments over 12 weeks.

Who should consider this trial

Good fit: Ideal candidates are adults aged 21-65 who meet the criteria for moderate to severe methamphetamine use disorder.

Not a fit: Patients with significant psychiatric disorders or other substance use disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a novel non-invasive treatment option for individuals struggling with methamphetamine use disorder.

How similar studies have performed: While the use of TMS for substance use disorders is still emerging, preliminary studies suggest potential efficacy, making this approach both innovative and promising.

Eligibility criteria

Inclusion Criteria:

1. Age 21-65 years inclusive;
2. Meets DSM-5 criteria for past-year moderate or severe methamphetamine use disorder;
3. By Timeline Follow Back endorses at least 10 days of methamphetamine use out of the last month;
4. Provides a urine drug screen positive for methamphetamine;
5. Able to provide informed consent;
6. No change in current psychiatric medication regimen, or medication free, for at least 4 weeks prior to study entry;
7. Adequate English proficiency for study consent, and completion of the study instruments.

Exclusion Criteria:

1. Lifetime non-substance-induced psychotic disorders, schizophrenia, schizoaffective disorder or bipolar disorder defined by DSM-5;
2. Current diagnosis of DSM-5 drug use disorder other than stimulant, cannabis or nicotine use disorder;
3. Non-substance-induced manic episode within the past 3 years or major depressive episode in the past year;
4. Current clinically significant neurological disorder or medical illness, including history of seizures, cardiovascular disease/cardiac event, which in the opinion of the study physician would make study participation unsafe;
5. Presence of a clinically significant abnormality on baseline MRI;
6. Inability to have an MRI;
7. Currently breastfeeding, is currently pregnant or lack of use of effective contraception in women of childbearing age, as assessed by urine pregnancy test and self-report (participants will consent to continue effective contraceptives during the study);
8. Active criminal justice involvement (i.e., any unresolved legal problems that could jeopardize continuation or completion of the study);
9. History of head injury with loss of consciousness for more than 15 minutes;
10. Diagnosis of dementia;
11. Prescribed benzodiazepines or anticonvulsants;
12. Currently enrolled in formal substance use disorder treatment;
13. Metal implants or non-removable metal objects above the waist;
14. Lifetime history of prior clinical treatment with TMS;
15. Serious risk of suicide or homicide;
16. Unable/unwilling to follow the study procedures;
17. History of intractable migraine;
18. Assessed to be at risk for alcohol or opioid withdrawal.

Where this trial is running

Aurora, Colorado

• University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (RECRUITING)

Study contacts

• Study coordinator: Joseph T Sakai, MD

Conditions: Methamphetamine Use Disorder