Theta Burst TMS for Treatment of Methamphetamine Use Disorder

April 24, 2024 updated by: Sooraj John, Carilion Clinic

Theta Burst Transcranial Magnetic Stimulation for the Treatment of Methamphetamine Use Disorder

This study is using Transcranial Magnetic Stimulation (TMS) to determine if interventional psychiatry treatment can help with the treatment of Methamphetamine Use Disorder. Individuals with Methamphetamine Use Disorder will receive 5 consecutive TMS treatment sessions based off of randomization. Participants will be randomized to one of two groups. TMS treatment arm or sham-TMS arm.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients who meet criteria for the study and who agree to participate in the research study will be randomized to an arm of the study by chance (like tossing a coin). The chance of receiving TMS or sham-TMS is equal. They will be enrolled in either the TMS or sham-TMS group (both groups involve 5 TMS or sham-TMS sessions). The study doctor and the participant will not know whether they are in the TMS or sham-TMS group. The purpose of this study is to determine if TMS is a potential treatment for methamphetamine use disorder. TMS is a non-invasive technique that uses magnetic pulses to temporarily stimulate specific brain areas in awake people (without the need for surgery, anesthetic, or other invasive procedures). This study will test whether a specific type of TMS (intermittent theta burst) over the forehead can produce a reduction in things that may prompt you to want to use methamphetamines.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Virginia
      • Roanoke, Virginia, United States, 24014
        • Recruiting
        • Carilion Clinic
        • Contact:
          • Sooraj John, M.D.
        • Contact:
          • Maryann Hollen, B.S.
          • Phone Number: 540-566-8081

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Individuals actively struggling with Methamphetamine Use Disorder
  • Must be currently enrolled in Carilion Clinic Office Based Addiction Treatment (OBAT) program

Exclusion Criteria:

- Individuals currently struggling with alcohol use and/or benzodiazepine use

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transcranial Magnetic Stimulation (TMS)
This arm receives the TMS treatments.
Device: Transcranial Magnetic Stimulation
Transcranial Magnetic Stimulation (TMS using Intermittent theta burst stimulation (iTBS)
Other Names:
  • TMS
  • iTBS
Sham Comparator: Sham-TMS
This arm receives sham TMS treatments.
Device: Sham Transcranial Magnetic Stimulation
Participants will not receive intermittent theta burst stimulation during the sham-TMS sessions
Other Names:
  • Sham-TMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stimulant Craving Questionnaire (STCQ)
Time Frame: Baseline/Visit 2, daily during iTBS/Sham-TMS, 3 days after-, 1 week after-, 2 weeks-after, and one month after completion of iTBS/Sham TMS
Self-rated cravings for stimulants
Baseline/Visit 2, daily during iTBS/Sham-TMS, 3 days after-, 1 week after-, 2 weeks-after, and one month after completion of iTBS/Sham TMS
Urine Drug Screen (UDS)
Time Frame: Baseline/Visit 2, day 5 of iTBS/Sham TMS, 3 days after-, 1 week after-, 2 weeks-after, and one month after completion of iTBS/Sham TMS
Urine drug screens
Baseline/Visit 2, day 5 of iTBS/Sham TMS, 3 days after-, 1 week after-, 2 weeks-after, and one month after completion of iTBS/Sham TMS

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Generalized Anxiety Disorder-7 (GAD-7)
Time Frame: Screening/Visit1 and day 5 of iTBS/Sham TMS
Self-rated anxiety severity
Screening/Visit1 and day 5 of iTBS/Sham TMS
Patient Health Questionnaire-9 (PHQ-9)
Time Frame: Screening/Visit 1 and day 5 of iTBS/Sham TMS
self-rated depression severity
Screening/Visit 1 and day 5 of iTBS/Sham TMS
Quality - Life Enjoyment Scale - Questionnaire (Q-LES-Q)
Time Frame: Baseline/Visit 2, day 5 of iTBS/Sham TMS, 3 days after-, 1 week after-, 2 weeks-after, and one month after completion of iTBS/Sham TMS
Self-rated Quality of Life scale
Baseline/Visit 2, day 5 of iTBS/Sham TMS, 3 days after-, 1 week after-, 2 weeks-after, and one month after completion of iTBS/Sham TMS
Hamilton Anxiety Scale (HAM-A)
Time Frame: Baseline/Visit 2, day 5 of iTBS/Sham TMS, 3 days after-, 1 week after-, 2 weeks-after, and one month after completion of iTBS/Sham TMS
Clinician rated anxiety
Baseline/Visit 2, day 5 of iTBS/Sham TMS, 3 days after-, 1 week after-, 2 weeks-after, and one month after completion of iTBS/Sham TMS
Montgomery Asberg Depression Rating Scale (MADRS)
Time Frame: Screening/Visit 1, Baseline/Visit 2, day 5 of iTBS/Sham TMS, 3 days after-, 1 week after-, 2 weeks-after, and one month after completion of iTBS/Sham TMS
Clinician rated depression
Screening/Visit 1, Baseline/Visit 2, day 5 of iTBS/Sham TMS, 3 days after-, 1 week after-, 2 weeks-after, and one month after completion of iTBS/Sham TMS
Clinical Global Impression - Severity (CGI-S)
Time Frame: Screening/Visit 1
Clinician rated illness severity
Screening/Visit 1
Clinical Global Impression - Improvement (CGI-I)
Time Frame: Baseline/Visit 2, day 5 of iTBS/Sham TMS, 3 days after-, 1 week after-, 2 weeks-after, and one month after completion of iTBS/Sham TMS
Clinician rated illness improvement
Baseline/Visit 2, day 5 of iTBS/Sham TMS, 3 days after-, 1 week after-, 2 weeks-after, and one month after completion of iTBS/Sham TMS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carilion Clinic

Collaborators

Virginia Polytechnic Institute and State University

Investigators

  • Principal Investigator: Sooraj John, M.D., Carilion Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

April 15, 2024

First Submitted That Met QC Criteria

April 15, 2024

First Posted (Actual)

April 18, 2024

Study Record Updates

Last Update Posted (Actual)

April 26, 2024

Last Update Submitted That Met QC Criteria

April 24, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 22-1754

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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