Pilot TMS for Methamphetamine Use Disorder

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

Interventions

DEVICE

Transcranial Magnetic Stimulation--DPFC first, MPFC second

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.

DEVICE

Transcranial Magnetic Stimulation--MPFC first, DPFC second

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.

Sponsors & Collaborators

• University of New Mexico

  collaborator OTHER

• University of Utah

  collaborator OTHER

• Ryan M. Carnahan

  lead OTHER

Principal Investigators

• Ryan Carnahan, PharmD, MS · University of Iowa

• Alison C Lynch, MD, MS · University of Iowa

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-10-06

Primary Completion

2022-03-31

Completion

2022-03-31

FDA Device

Yes

Countries

• United States

Study Locations