Theta Burst TMS for Treatment of Methamphetamine Use Disorder

NCT06372288 | Recruiting FDA Device

• 1 other identifier: 22-1754
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Methamphetamine Abuse

Keywords

Transcranial Magnetic Stimulation (TMS); methamphetamine use disorder

Outcome Measures

Primary Outcomes (2)

• Stimulant Craving Questionnaire (STCQ)

  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)

  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 Outcomes (7)

• Generalized Anxiety Disorder-7 (GAD-7)

  Screening/Visit1 and day 5 of iTBS/Sham TMS

• Patient Health Questionnaire-9 (PHQ-9)

  Screening/Visit 1 and day 5 of iTBS/Sham TMS

• Quality - Life Enjoyment Scale - Questionnaire (Q-LES-Q)

  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)

  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)

  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

Study Arms (2)

Transcranial Magnetic Stimulation (TMS)

EXPERIMENTAL

This arm receives the TMS treatments.

Device: Transcranial Magnetic Stimulation

Sham-TMS

SHAM COMPARATOR

This arm receives sham TMS treatments.

Device: Sham Transcranial Magnetic Stimulation

Interventions

Transcranial Magnetic Stimulation DEVICE

Transcranial Magnetic Stimulation (TMS using Intermittent theta burst stimulation (iTBS)

Also known as: TMS, iTBS

Transcranial Magnetic Stimulation (TMS)

Sham Transcranial Magnetic Stimulation DEVICE

Participants will not receive intermittent theta burst stimulation during the sham-TMS sessions

Also known as: Sham-TMS

Sham-TMS

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Carilion Clinic: lead
• Virginia Polytechnic Institute and State University: collaborator

Study Sites (1)

Carilion Clinic

Roanoke, Virginia, 24014, United States

RECRUITING

Related Publications (8)

• Su H, Chen T, Jiang H, Zhong N, Du J, Xiao K, Xu D, Song W, Zhao M. Intermittent theta burst transcranial magnetic stimulation for methamphetamine addiction: A randomized clinical trial. Eur Neuropsychopharmacol. 2020 Feb;31:158-161. doi: 10.1016/j.euroneuro.2019.12.114. Epub 2020 Jan 2.

  PMID: 31902567 BACKGROUND

• Liu Q, Sun H, Hu Y, Wang Q, Zhao Z, Dong D, Shen Y. Intermittent Theta Burst Stimulation vs. High-Frequency Repetitive Transcranial Magnetic Stimulation in the Treatment of Methamphetamine Patients. Front Psychiatry. 2022 Apr 26;13:842947. doi: 10.3389/fpsyt.2022.842947. eCollection 2022.

  PMID: 35558419 BACKGROUND

• Zhao D, Li Y, Liu T, Voon V, Yuan TF. Twice-Daily Theta Burst Stimulation of the Dorsolateral Prefrontal Cortex Reduces Methamphetamine Craving: A Pilot Study. Front Neurosci. 2020 Mar 25;14:208. doi: 10.3389/fnins.2020.00208. eCollection 2020.

  PMID: 32273837 BACKGROUND

• Wang LJ, Mu LL, Ren ZX, Tang HJ, Wei YD, Wang WJ, Song PP, Zhu L, Ling Q, Gao H, Zhang L, Song X, Wei HF, Chang LX, Wei T, Wang YJ, Zhao W, Wang Y, Liu LY, Zhou YD, Zhou RD, Xu HS, Jiao DL. Predictive Role of Executive Function in the Efficacy of Intermittent Theta Burst Transcranial Magnetic Stimulation Modalities for Treating Methamphetamine Use Disorder-A Randomized Clinical Trial. Front Psychiatry. 2021 Dec 2;12:774192. doi: 10.3389/fpsyt.2021.774192. eCollection 2021.

  PMID: 34925101 BACKGROUND

• Chen T, Su H, Wang L, Li X, Wu Q, Zhong N, Du J, Meng Y, Duan C, Zhang C, Shi W, Xu D, Song W, Zhao M, Jiang H. Modulation of Methamphetamine-Related Attention Bias by Intermittent Theta-Burst Stimulation on Left Dorsolateral Prefrontal Cortex. Front Cell Dev Biol. 2021 Aug 3;9:667476. doi: 10.3389/fcell.2021.667476. eCollection 2021.

  PMID: 34414178 BACKGROUND

• Hanlon CA, Dowdle LT, Correia B, Mithoefer O, Kearney-Ramos T, Lench D, Griffin M, Anton RF, George MS. Left frontal pole theta burst stimulation decreases orbitofrontal and insula activity in cocaine users and alcohol users. Drug Alcohol Depend. 2017 Sep 1;178:310-317. doi: 10.1016/j.drugalcdep.2017.03.039. Epub 2017 May 30.

  PMID: 28686990 BACKGROUND

• Su H, Zhong N, Gan H, Wang J, Han H, Chen T, Li X, Ruan X, Zhu Y, Jiang H, Zhao M. High frequency repetitive transcranial magnetic stimulation of the left dorsolateral prefrontal cortex for methamphetamine use disorders: A randomised clinical trial. Drug Alcohol Depend. 2017 Jun 1;175:84-91. doi: 10.1016/j.drugalcdep.2017.01.037. Epub 2017 Mar 29.

  PMID: 28410525 BACKGROUND

• Cole EJ, Stimpson KH, Bentzley BS, Gulser M, Cherian K, Tischler C, Nejad R, Pankow H, Choi E, Aaron H, Espil FM, Pannu J, Xiao X, Duvio D, Solvason HB, Hawkins J, Guerra A, Jo B, Raj KS, Phillips AL, Barmak F, Bishop JH, Coetzee JP, DeBattista C, Keller J, Schatzberg AF, Sudheimer KD, Williams NR. Stanford Accelerated Intelligent Neuromodulation Therapy for Treatment-Resistant Depression. Am J Psychiatry. 2020 Aug 1;177(8):716-726. doi: 10.1176/appi.ajp.2019.19070720. Epub 2020 Apr 7.

  PMID: 32252538 BACKGROUND

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Sooraj John, M.D.

  Carilion Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sooraj John, M.D.

CONTACT

540-981-7000; research@carilionclinic.org

Maryann Hollen, B.S.

CONTACT

540-566-8081; research@carilionclinic.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: One study personnel not involved in participant interventions will be unblinded and will randomize participants and confirm the set up of the device for the session prior to the blinded study personnel interacting with the participant. Both the participant and the blinded study personnel will not know which group the participant will be part of throughout the study sessions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Model Details: Participants will be randomized to either receive 5 transcranial magnetic stimulations or 5 sham transcranial magnetic stimulation (no therapeutic levels of stimulation) sessions.

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 18, 2024
• Study Start: December 20, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: April 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)