Testing an Accelerated TMS Protocol for Methamphetamine Use Disorder

University of Colorado Denver (CU Denver)

Status: Enrolling

Conditions: Methamphetamine Use Disorder

Treatments: Device: Active TMS; Device: Sham TMS

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06320366

23-1044

K24DA058882 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The investigators will evaluate the effects of an accelerated Transcranial Magnetic Stimulation (TMS) protocol of the left dorsolateral prefrontal cortex (DLPFC) for moderate to severe methamphetamine use disorder. This is a randomized parallel group design to assess feasibility and safety, evaluate efficacy (use, craving) and identify magnetic resonance imaging (resting state and cue craving) associated with group/outcomes.

Full description

In a randomized double-blind parallel-group sham-controlled design (n=20) administer a 5-day accelerated iTBS protocol (40 treatments) to the left dorsolateral prefrontal cortex during a short inpatient stay. Magnetic resonance imaging will be completed pre-post TMS and participants will be followed for 12 weeks.

Enrollment: 20 estimated patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups, including a placebo group

Sham TMS

Placebo Comparator group

Description:

Participants have baseline assessments/evaluation, are admitted to the inpatient research unit, randomized via permuted block design to 5 days of sham TMS, and then have weekly study visits for the next 12 weeks.

Treatment:

Device: Sham TMS

Active TMS

Experimental group

Description:

Participants have baseline assessments/evaluation, are admitted to the inpatient research unit, randomized via permuted block design to 5 days of active TMS, and then have weekly study visits for the next 12 weeks.

Treatment:

Device: Active TMS