Pilot TMS for Methamphetamine Use Disorder

NCT04449055 | Completed Results FDA Device

• 1 other identifier: 202001387
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stimulant Dependence; Methamphetamine-dependence; Addiction, Drug

Keywords

methamphetamine; addiction treatment; transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (2)

• Retention in the Study

  Time to study dropout (to assess feasibility and tolerability of the protocol)

  Baseline to 12 weeks (continuous)

• Retention in Psychosocial Treatment

  Time to discontinuation of psychosocial treatment

  Baseline to 18 days (continuous--assessed weekly)

Secondary Outcomes (21)

• Functional Connectivity of the Dorsolateral Prefrontal Cortex and Anterior Insula

  Baseline, 4 weeks

• Functional Connectivity Dorsolateral Prefrontal Cortex and Anterior Cingulate Cortex

  Baseline, 4 weeks

• Functional Connectivity of the Medial Prefrontal Cortex and Ventral Striatum (Nucleus Accumbens)

  Baseline, 4 weeks

• Flanker Inhibitor Control and Attention Test, Age 12+

  Baseline, 4 weeks

• Kirby Delay Discounting Questionnaire, 27 Item

  Baseline, 4 weeks

Study Arms (2)

DPFC first

EXPERIMENTAL

Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the dorsolateral prefrontal cortex stimulation first.

Device: Transcranial Magnetic Stimulation--DPFC first, MPFC second

MPFC first

EXPERIMENTAL

Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the medial prefrontal cortex stimulation first.

Device: Transcranial Magnetic Stimulation--MPFC first, DPFC second

Interventions

Transcranial Magnetic Stimulation--DPFC first, MPFC second DEVICE

Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder. Both treatments will be delivered at each TMS treatment visit. The DPFC first group will receive stimulation to the dorsolateral prefrontal cortex first and medial prefrontal cortex second at each treatment visit.

Also known as: Theta burst stimulation

DPFC first

Transcranial Magnetic Stimulation--MPFC first, DPFC second DEVICE

Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder. Both treatments will be delivered at each TMS treatment visit. The MPFC first group will receive stimulation to the medial prefrontal cortex first and DPFC second at each treatment visit.

Also known as: Theta burst stimulation

MPFC first

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.
• 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.
• Implanted device including pacemaker, coronary stent, defibrillator, or neurostimulation device that is not MRI-compatible
• Metal in body including bullets, shrapnel, metal slivers
• Claustrophobia

Sponsors & Collaborators

• Ryan M. Carnahan: lead
• University of New Mexico: collaborator
• University of Utah: collaborator

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Related Publications (5)

• Courtney KE, Ray LA. Methamphetamine: an update on epidemiology, pharmacology, clinical phenomenology, and treatment literature. Drug Alcohol Depend. 2014 Oct 1;143:11-21. doi: 10.1016/j.drugalcdep.2014.08.003. Epub 2014 Aug 17.

  PMID: 25176528 BACKGROUND

• Ma T, Sun Y, Ku Y. Effects of Non-invasive Brain Stimulation on Stimulant Craving in Users of Cocaine, Amphetamine, or Methamphetamine: A Systematic Review and Meta-Analysis. Front Neurosci. 2019 Oct 18;13:1095. doi: 10.3389/fnins.2019.01095. eCollection 2019.

  PMID: 31680830 BACKGROUND

• Zhang JJQ, Fong KNK, Ouyang RG, Siu AMH, Kranz GS. Effects of repetitive transcranial magnetic stimulation (rTMS) on craving and substance consumption in patients with substance dependence: a systematic review and meta-analysis. Addiction. 2019 Dec;114(12):2137-2149. doi: 10.1111/add.14753. Epub 2019 Aug 16.

  PMID: 31328353 BACKGROUND

• Makani R, Pradhan B, Shah U, Parikh T. Role of Repetitive Transcranial Magnetic Stimulation (rTMS) in Treatment of Addiction and Related Disorders: A Systematic Review. Curr Drug Abuse Rev. 2017;10(1):31-43. doi: 10.2174/1874473710666171129225914.

  PMID: 29189190 BACKGROUND

• Liang Y, Wang L, Yuan TF. Targeting Withdrawal Symptoms in Men Addicted to Methamphetamine With Transcranial Magnetic Stimulation: A Randomized Clinical Trial. JAMA Psychiatry. 2018 Nov 1;75(11):1199-1201. doi: 10.1001/jamapsychiatry.2018.2383.

  PMID: 30208372 BACKGROUND

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Ryan Carnahan
• Organization: The University of Iowa College of Public Health

ryan-carnahan@uiowa.edu

3193841556

Study Officials

• Ryan Carnahan, PharmD, MS

  University of Iowa

  PRINCIPAL INVESTIGATOR

• Alison C Lynch, MD, MS

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Randomized order of TMS site stimulated first

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: June 26, 2020
• Study Start: October 6, 2020
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: January 16, 2026
• Results First Posted: January 16, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)