A Pilot Study of Repetitive Transcranial Magnetic Stimulation for Treatment of Methamphetamine Use Disorders

NCT04883021 | Withdrawn FDA Device

• 1 other identifier: UNM HRRC# 20-077
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

We propose a single-arm clinical trial, with historical controls as a comparison group for select outcomes. Subjects with MAUD will receive 16 sessions of dual-target theta burst stimulation to the DLPFC and MPFC over 4 weeks. We will follow outcomes for 12 weeks. Outcomes include treatment retention, craving, self-reported MA or stimulant use, urine drug screen results, depressive symptoms, anxiety symptoms, sleep quality, quality of life, response inhibition, and functional connectivity. Magnetic resonance imaging (MRI) to measure functional connectivity at baseline and four weeks.

Conditions

Methamphetamine Abuse

Outcome Measures

Primary Outcomes (3)

• Rate of Retention in Study

  Percentage of subjects who complete the 4-week TMS treatment period.

  4 week visit

• Change in functional connectivity

  Change in connectivity index between the dorsolateral prefrontal cortex (DLPFC) and anterior insula

  4 week visit

• Change in Craving

  Change in the Brief Substance Craving Scale Score

  4 week visit

Study Arms (1)

Dual Target Theta Burst Stimulation

EXPERIMENTAL

The TMS intervention is open-label dual-target theta burst stimulation delivered in sequential fashion to the DLPFC and the MPFC.

Device: Dual Target Theta Burst Stimulation

Interventions

Dual Target Theta Burst Stimulation DEVICE

TMS treatment will be provided daily for 5 days, then daily for 5 days in week 2, and three times per week (Monday, Wednesday, Friday) in weeks 3 and 4. Treatment targeting will occur at the Beam F3 and FP1 scalp regions as defined by the 10-20 EEG system and previous publications. A Magventure MagPro X100 figure-8 coil with theta burst capabilities will be used to deliver the stimulus, including intermittent theta burst stimulation to the DLPFC (2 seconds of 50-Hz triplets delivered at 5 Hz, 8 seconds intertrain interval, 600 total pulses) and continuous theta burst to the MPFC (continuous 50-Hz stimulation triplets, 600 pulses). Stimulation will be delivered at 110% of the resting motor threshold.

Dual Target Theta Burst Stimulation

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

You may not qualify if:

• Age less than 18 years (TMS not studied in pediatric population)
• 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, bupropion, or stimulants.
• Current diagnosis of bipolar disorder, schizoaffective disorder, schizophrenia, or any other psychotic disorder.
• Legal or mental incompetency, or inability to consent to study.
• 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.
• Inability to complete the protocol, namely, inability to independently attend all study visits and TMS sessions on time.
• Prisoner
• Implanted device including pacemaker, coronary stent, defibrillator, or neurostimulation device that is not MRI-compatible
• Metal in body including bullets, shrapnel, metal slivers

Sponsors & Collaborators

• University of New Mexico: lead
• University of Iowa: collaborator
• University of Utah: collaborator

Study Sites (1)

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, 87106, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single arm prospective cohort study

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: May 12, 2021
• Study Start: August 1, 2020
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: September 30, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)