Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR001998 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Other | Group 1 will receive actual TMS (iTBS and cTBS) on days 2 and 3 and sham TMS on day 4. |
|
| Group 2 | Other | Group 2 will receive actual TMS (iTBS and cTBS) on days 2 and 4 and sham TMS on day 3. |
|
| Group 3 | Other | Group 3 will receive sham TMS on day 2 and actual TMS (iTBS and cTBS) on days 3 and 4. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patricia Garth, CRC | Contact | 859-382-7611 | psych_research@uky.edu, annette.garth@uky.edu |
| Name | Affiliation | Role |
|---|---|---|
| Gopalkumar Rakesh, MD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UK Department of Psychiatry | Recruiting | Lexington | Kentucky | 40509 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32273837 | 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. | |
| 35835436 | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Within participant design with a randomized sequence of interventions.
Not provided
Not provided
Not provided
| 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 TMS | Device | Sham TMS delivered with the MagVenture B65 A/P coil |
|
| 36265196 | 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. |
| 37217771 | 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. |
| 26947241 | 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. |
| 31902567 | 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. |
| 38501083 | 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. |
| 38086901 | 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. |
| 35558419 | 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. |
| 38161297 | 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. |
| 34711062 | 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. |
| 34414178 | 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. |
| 32980696 | 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. |
| 38852478 | 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. |