Transcranial Magnetic Stimulation for Methamphetamine Use Disorder in PLWH

NCT ID: NCT06830980

Last Updated: 2025-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-11

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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The investigators will compare how two theta burst paradigms, intermittent theta burst stimulation (iTBS) and continuous theta burst stimulation (cTBS), compare with sham TMS in changing methamphetamine craving and brain activity. iTBS, cTBS, and sham TMS will be delivered in an accelerated fashion (two sessions daily, separated by 50 minutes). iTBS will be delivered to the left dorsolateral prefrontal cortex (left dorsolateral prefrontal cortex), and cTBS will be delivered to the frontal pole. A brain MRI scan will be done before and after the iTBS/cTBS/sham TMS sessions. The study involves four visits. Each visit will last three hours. Hence, participants will spend a total of 12 hours in the study.

Conditions

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Methamphetamine Use Disorders HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Within participant design with a randomized sequence of interventions.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Group 1

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

Group Type OTHER

intermittent theta burst stimulation (iTBS)

Intervention Type 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.

continuous theta burst stimulation (cTBS)

Intervention Type 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.

Sham TMS

Intervention Type DEVICE

Sham TMS delivered with the MagVenture B65 A/P coil

Group 2

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

Group Type OTHER

intermittent theta burst stimulation (iTBS)

Intervention Type 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.

continuous theta burst stimulation (cTBS)

Intervention Type 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.

Sham TMS

Intervention Type DEVICE

Sham TMS delivered with the MagVenture B65 A/P coil

Group 3

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

Group Type OTHER

intermittent theta burst stimulation (iTBS)

Intervention Type 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.

continuous theta burst stimulation (cTBS)

Intervention Type 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.

Sham TMS

Intervention Type DEVICE

Sham TMS delivered with the MagVenture B65 A/P coil

Interventions

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intermittent theta burst stimulation (iTBS)

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

Intervention Type DEVICE

continuous theta burst stimulation (cTBS)

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

Intervention Type DEVICE

Sham TMS

Sham TMS delivered with the MagVenture B65 A/P coil

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role collaborator

Gopalkumar Rakesh

OTHER

Sponsor Role lead

Responsible Party

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Gopalkumar Rakesh

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Gopalkumar Rakesh, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

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UK Department of Psychiatry

Lexington, Kentucky, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Patricia Garth, CRC

Role: CONTACT

Facility Contacts

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Annette Garth, CRC

Role: primary

859-382-7611

Gopalkumar Rakesh, MD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 32273837 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35835436 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36265196 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37217771 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26947241 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31902567 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38501083 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38086901 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35558419 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38161297 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34711062 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34414178 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32980696 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38852478 (View on PubMed)

Other Identifiers

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UL1TR001998

Identifier Type: NIH

Identifier Source: secondary_id

View Link

100353

Identifier Type: -

Identifier Source: org_study_id

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