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

NCT04883021 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-09-30

No results posted yet for this study

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

Interventions

DEVICE

Dual Target Theta Burst Stimulation

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.

Sponsors & Collaborators

  • University of Iowa

    collaborator OTHER

  • University of Utah

    collaborator OTHER

  • University of New Mexico

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-01
Primary Completion
2021-05-31
Completion
2021-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04883021 on ClinicalTrials.gov