Methamphetamine Use DisordersNCT06830980
Transcranial Magnetic Stimulation for Methamphetamine Use Disorder in PLWH
A study testing intermittent theta burst stimulation (iTBS) and continuous theta burst stimulation (cTBS) in people with Methamphetamine Use Disorders and HIV, run by Gopalkumar Rakesh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Methamphetamine Use Disorders, HIV
- What is being tested?
- intermittent theta burst stimulation (iTBS) and continuous theta burst stimulation (cTBS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2025to 26 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- lack of attentional bias to methamphetamine cues
- a positive pregnancy test for female participants
- abnormal brain MRI
Trial locations and contacts
1 site in 1 country.
United States1 site
UK Department of Psychiatry
Lexington, Kentucky, 40509
About this study
Official title: TMS (Transcranial Magnetic Stimulation) for Methamphetamine Use Disorder in People Living With HIV
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.
Read the detailed description
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
- Methamphetamine Use Disorders, HIV
- Being tested
- intermittent theta burst stimulation (iTBS), continuous theta burst stimulation (cTBS), Sham TMS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
Sham TMSDevice
Sham TMS delivered with the MagVenture B65 A/P coil
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Other | Group 1 will receive actual TMS (iTBS and cTBS) on days 2 and 3 and sham TMS on day 4. Receives: 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. Receives: 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. Receives: Device: intermittent theta burst stimulation (iTBS); Device: continuous theta burst stimulation (cTBS); Device: Sham TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cue-induced methamphetamine craving
Measured on the visual analog scale (VAS) Scored 0 to 100 with 0=no craving and 100=the most craving.
Measured: Baseline and before and after each TMS session up to 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start11 Mar 2025
- Primary completion26 May 2026
- Study completion26 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Methamphetamine Use DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Within participant design with a randomized sequence of interventions.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gopalkumar Rakesh
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor-investigator, Gopalkumar Rakesh, University of Kentucky
- Investigators
- Gopalkumar Rakesh, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06830980
- Sponsor's protocol ID
- 100353
- Other IDs
- UL1TR001998
- Status last verified
- Aug 2026
- First submitted
- 10 Feb 2025
- Last updated
- 6 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 32273837Wen 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.
PubMed 35835436Wang 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.
PubMed 36265196van 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.
PubMed 37217771Suppa 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.
PubMed 26947241Su 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.
PubMed 31902567Rakesh 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.
PubMed 38501083Mehta 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.
PubMed 38086901Liu 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.
PubMed 35558419Geoly 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.
PubMed 38161297Cole 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.
PubMed 34711062Chen 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.
PubMed 34414178Chen 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.
PubMed 32980696Ballester 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.
PubMed 38852478
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TMS (Transcranial Magnetic Stimulation) for Methamphetamine Use Disorder in People Living With HIV
- ClinicalTrials.gov ID
- NCT06830980
- Acronym / sponsor ID
- 100353
- Conditions
- Methamphetamine Use Disorders, HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Gopalkumar RakeshUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 11 Mar 2025 (actual)
- Primary completion
- 26 May 2026 (actual)
- Study completion
- 26 May 2026 (actual)
- First posted
- 17 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Within participant design with a randomized sequence of interventions.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Other | Device: intermittent theta burst stimulation (iTBS), Device: continuous theta burst stimulation (cTBS), Device: Sham TMSGroup 1 will receive actual TMS (iTBS and cTBS) on days 2 and 3 and sham TMS on day 4. |
| Group 2 | Other | Device: intermittent theta burst stimulation (iTBS), Device: continuous theta burst stimulation (cTBS), Device: Sham TMSGroup 2 will receive actual TMS (iTBS and cTBS) on days 2 and 4 and sham TMS on day 3. |
| Group 3 | Other | Device: intermittent theta burst stimulation (iTBS), Device: continuous theta burst stimulation (cTBS), Device: Sham TMSGroup 3 will receive sham TMS on day 2 and actual TMS (iTBS and cTBS) on days 3 and 4. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- Traumatic brain injury
- h/o seizure disorder
- h/o or current diagnosis of schizophrenia
- intracranial metal shrapnel
- previous adverse effects with TMS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Group 1, Group 2, Group 3 |
| 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. | Device | Group 1, Group 2, Group 3 |
| Sham TMSSham TMS delivered with the MagVenture B65 A/P coil | Device | Group 1, Group 2, Group 3 |
Primary outcome
Cue-induced methamphetamine craving
Time frame: Baseline and before and after each TMS session up to 4 days
Measured on the visual analog scale (VAS) Scored 0 to 100 with 0=no craving and 100=the most craving.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Background: PubMed 32273837Zhao 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.
- Background: PubMed 35835436Wen 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.
- Background: PubMed 36265196Wang 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.
- Background: PubMed 37217771van 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.
- Background: PubMed 26947241Suppa 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.
- Background: PubMed 31902567Su 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.
- Background: PubMed 38501083Rakesh 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.
- Background: PubMed 38086901Mehta 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.
- Background: PubMed 35558419Liu 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.
- Background: PubMed 38161297Geoly 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.
- Background: PubMed 34711062Cole 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.
- Background: PubMed 34414178Chen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gopalkumar Rakesh, MD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intermittent theta burst stimulation (iTBS) and continuous theta burst stimulation (cTBS) in people with Methamphetamine Use Disorders and HIV, run by Gopalkumar Rakesh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cue-induced methamphetamine craving (time frame: Baseline and before and after each TMS session up to 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06830980, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.