Pilot TMS for Methamphetamine Use Disorder

Completed · Not applicable

Conditions studied: Stimulant Dependence, Methamphetamine-dependence, Addiction, Drug

In brief

This is a pilot study to test the feasibility of a recruitment strategy and study protocol to examine the effects of a dual target transcranial magnetic stimulation treatment in methamphetamine use disorder. The study will test intermittent theta burst stimulation (TBS) targeting the dorsolateral prefrontal cortex (DLPFC) combined with continuous TBS targeting the medial prefrontal cortex (MPFC) in people with methamphetamine use disorder (MAUD) who are engaged in psychosocial treatment. We will randomize the order in which these treatments are delivered at each treatment session, but all subjects will receive both treatments. Intermittent TBS targeting the DLPFC is approved by the Food and Drug Administration for major depressive disorder, and continuous TBS targeting the MPFC has been studied in cocaine use disorder. We will administer this dual target TBS daily for 2 weeks, followed by three times weekly for 2 weeks, and monitor depressive symptoms, anxiety, sleep, craving, quality of life, and methamphetamine use for three months. Changes in functional connectivity of brain circuits will be evaluated with functional magnetic resonance imaging (fMRI) before and after treatment. We expect to observe changes in connectivity between the DLPFC, MPFC, and other regions implicated in addiction and impulsivity. Furthermore, we will evaluate if baseline differences in functional connectivity can be used to predict response. Psychological tests focusing on state impulsivity and risk taking will be administered, and we expect to observe reductions in these characteristics after treatment. We will test this protocol in 20 patients recruited from clinical care settings at University of Iowa Hospitals and Clinics, University of New Mexico Health System, and University of Utah Health to illustrate the feasibility of recruitment and completing the protocol, to support an external funding proposal.

Key facts

Study ID

NCT04449055

Run by

Ryan M. Carnahan

People needed

19

Starts

2020-10-06

Expected to finish

2022-03-31

Last updated by the study team

2026-01-16

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed with an active methamphetamine use disorder
• Is engaged in psychosocial treatment or articulates a plan to engage in psychosocial treatment for methamphetamine use disorder during the study period
• Age 18 to 60 years
• Able to consent for treatment and research participation
• English-speaking
• Receiving care from UIHC's Addiction Medicine service. This includes patients in the Crisis Stabilization Unit, seen by the inpatient consultation service, enrolling in partial hospitalization or intensive outpatient treatment, or seen in the outpatient Addiction Medicine clinics.

You may not qualify if…

• Age less than 18 years
• Patients that are excluded during TMS assessment including: patients with epilepsy or seizure disorder, patients with implanted ferromagnetic equipment in their face or skull near the stimulation target.
• Current medical treatment with clozapine or stimulants.
• Current diagnosis of bipolar disorder, schizoaffective disorder, schizophrenia, that is deemed by research team psychiatrists not to have been drug-induced. Psychotic disorder not associated with drug use per the MINI International Neuropsychiatric Interview. Psychosis NOS, in remission, or drug-induced psychotic episodes are not exclusion criteria since these may be related to methamphetamine misuse.
• Lacks the mental capacity to provide informed consent (i.e. not able to demonstrate understanding of the risks and benefits of participation)
• Has a court appointed guardian.
• Unstable medical illness.
• Current diagnosis of neurological disorder or neurocognitive disorder.
• Prior neurosurgical procedure.
• History of seizure.
• History of ECT treatment within the past three months.
• History of any previous TMS treatment.
• Known inability to complete the protocol, as assessed by asking them if they are able to make it to all visits for this study without assistance.
• MRI Exclusion criteria:
• Implanted device including pacemaker, coronary stent, defibrillator, or neurostimulation device that is not MRI-compatible
• Metal in body including bullets, shrapnel, metal slivers
• Claustrophobia
• Uncontrolled high blood pressure
• Atrial fibrillation
• Significant heart disease
• Hemodynamic instability
• Kidney disease
• Pregnant

Where it is running

• University of Iowa — Iowa City, Iowa, United States

Full record on ClinicalTrials.gov

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