Transcranial Magnetic Stimulation for Methamphetamine Use Disorder in PLWH

NCT06830980 | Recruiting FDA Device

• 2 other identifiers: 100353UL1TR001998
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to learn more about how accelerated theta burst stimulation affects methamphetamine craving and brain activity. Theta burst stimulation is a unique transcranial magnetic stimulation (TMS) paradigm that is efficient and potent.

Conditions

Methamphetamine Use Disorders; HIV

Outcome Measures

Primary Outcomes (1)

• Cue-induced methamphetamine craving

  Measured on the visual analog scale (VAS) Scored 0 to 100 with 0=no craving and 100=the most craving.

  Baseline and before and after each TMS session up to 4 days

Study Arms (3)

Group 1

OTHER

Group 1 will receive actual TMS (iTBS and cTBS) on days 2 and 3 and sham TMS on day 4.

Device: intermittent theta burst stimulation (iTBS); Device: continuous theta burst stimulation (cTBS); Device: Sham TMS

Group 2

OTHER

Group 2 will receive actual TMS (iTBS and cTBS) on days 2 and 4 and sham TMS on day 3.

Device: intermittent theta burst stimulation (iTBS); Device: continuous theta burst stimulation (cTBS); Device: Sham TMS

Group 3

OTHER

Group 3 will receive sham TMS on day 2 and actual TMS (iTBS and cTBS) on days 3 and 4.

Device: intermittent theta burst stimulation (iTBS); Device: continuous theta burst stimulation (cTBS); Device: Sham TMS

Interventions

intermittent theta burst stimulation (iTBS) DEVICE

iTBS is an excitatory TMS paradigm that delivers 1800 pulses to the left dlPFC. Participants will receive 2 iTBS sessions separated by 50 minutes.

Group 1; Group 2; Group 3

continuous theta burst stimulation (cTBS) DEVICE

cTBS is an inhibitory TMS paradigm that delivers 1800 pulses to the frontal pole. Participants will receive 2 iTBS sessions separated by 50 minutes.

Group 1; Group 2; Group 3

Sham TMS DEVICE

Sham TMS delivered with the MagVenture B65 A/P coil

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults in the age group 18-65 years
• Able to read and understand English
• Able to provide informed consent
• Diagnosed with HIV
• History of current or previous Methamphetamine Use Disorder
• Endorse craving for methamphetamine
• Demonstrate an attentional bias for methamphetamine

You may not qualify if:

• Traumatic brain injury
• h/o seizure disorder
• h/o or current diagnosis of schizophrenia
• intracranial metal shrapnel
• previous adverse effects with TMS
• sub-threshold consistency while performing behavioral tasks
• lack of attentional bias to methamphetamine cues
• a positive pregnancy test for female participants
• abnormal brain MRI

Sponsors & Collaborators

• Gopalkumar Rakesh: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

UK Department of Psychiatry

Lexington, Kentucky, 40509, United States

RECRUITING

Related Publications (14)

• 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

• Wen Y, Li Y, Jiang F, Dong X. TBS combined with virtual-reality reconsolidation intervention for methamphetamine use disorder: A pilot study. Brain Stimul. 2022 Jul-Aug;15(4):996-998. doi: 10.1016/j.brs.2022.07.001. Epub 2022 Jul 12. No abstract available.

  PMID: 35835436 BACKGROUND

• Wang W, Zhu Y, Wang L, Mu L, Zhu L, Ding D, Ren Z, Yang D, Tang H, Zhang L, Song P, Wei H, Chang L, Wang Z, Ling Q, Gao H, Liu L, Jiao D, Xu H. High-frequency repetitive transcranial magnetic stimulation of the left dorsolateral prefrontal cortex reduces drug craving and improves decision-making ability in methamphetamine use disorder. Psychiatry Res. 2022 Nov;317:114904. doi: 10.1016/j.psychres.2022.114904. Epub 2022 Oct 12.

  PMID: 36265196 BACKGROUND

• van Rooij SJH, Arulpragasam AR, McDonald WM, Philip NS. Accelerated TMS - moving quickly into the future of depression treatment. Neuropsychopharmacology. 2024 Jan;49(1):128-137. doi: 10.1038/s41386-023-01599-z. Epub 2023 May 22.

  PMID: 37217771 BACKGROUND

• Suppa A, Huang YZ, Funke K, Ridding MC, Cheeran B, Di Lazzaro V, Ziemann U, Rothwell JC. Ten Years of Theta Burst Stimulation in Humans: Established Knowledge, Unknowns and Prospects. Brain Stimul. 2016 May-Jun;9(3):323-335. doi: 10.1016/j.brs.2016.01.006. Epub 2016 Jan 27.

  PMID: 26947241 BACKGROUND

• 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

• Rakesh G, Adams TG, Morey RA, Alcorn JL 3rd, Khanal R, Su AE, Himelhoch SS, Rush CR. Intermittent theta burst stimulation and functional connectivity in people living with HIV/AIDS who smoke tobacco cigarettes: a preliminary pilot study. Front Psychiatry. 2024 Mar 4;15:1315854. doi: 10.3389/fpsyt.2024.1315854. eCollection 2024.

  PMID: 38501083 BACKGROUND

• Mehta DD, Praecht A, Ward HB, Sanches M, Sorkhou M, Tang VM, Steele VR, Hanlon CA, George TP. A systematic review and meta-analysis of neuromodulation therapies for substance use disorders. Neuropsychopharmacology. 2024 Mar;49(4):649-680. doi: 10.1038/s41386-023-01776-0. Epub 2023 Dec 12.

  PMID: 38086901 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

• Geoly AD, Kratter IH, Toosi P, Cole EJ, Sahlem GL, Williams NR. Sustained Efficacy of Stanford Neuromodulation Therapy (SNT) in Open-Label Repeated Treatment. Am J Psychiatry. 2024 Jan 1;181(1):71-73. doi: 10.1176/appi.ajp.20230113. No abstract available.

  PMID: 38161297 BACKGROUND

• Cole EJ, Phillips AL, Bentzley BS, Stimpson KH, Nejad R, Barmak F, Veerapal C, Khan N, Cherian K, Felber E, Brown R, Choi E, King S, Pankow H, Bishop JH, Azeez A, Coetzee J, Rapier R, Odenwald N, Carreon D, Hawkins J, Chang M, Keller J, Raj K, DeBattista C, Jo B, Espil FM, Schatzberg AF, Sudheimer KD, Williams NR. Stanford Neuromodulation Therapy (SNT): A Double-Blind Randomized Controlled Trial. Am J Psychiatry. 2022 Feb;179(2):132-141. doi: 10.1176/appi.ajp.2021.20101429. Epub 2021 Oct 29.

  PMID: 34711062 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

• Chen T, Su H, Li R, Jiang H, Li X, Wu Q, Tan H, Zhang J, Zhong N, Du J, Gu H, Zhao M. The exploration of optimized protocol for repetitive transcranial magnetic stimulation in the treatment of methamphetamine use disorder: A randomized sham-controlled study. EBioMedicine. 2020 Oct;60:103027. doi: 10.1016/j.ebiom.2020.103027. Epub 2020 Sep 25.

  PMID: 32980696 BACKGROUND

• Ballester J, Marchand WR, Philip NS. Transcranial magnetic stimulation for methamphetamine use disorder: A scoping review within the neurocircuitry model of addiction. Psychiatry Res. 2024 Aug;338:115995. doi: 10.1016/j.psychres.2024.115995. Epub 2024 May 29.

  PMID: 38852478 BACKGROUND

Study Officials

• Gopalkumar Rakesh, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia Garth, CRC

CONTACT

859-382-7611; psych_research@uky.edu, annette.garth@uky.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Within participant design with a randomized sequence of interventions.

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 17, 2025
• Study Start: March 11, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 24, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)