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| Name | Class |
|---|---|
| Virginia Polytechnic Institute and State University | OTHER |
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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.
Patients who meet criteria for the study and who agree to participate in the research study will be randomized to an arm of the study by chance (like tossing a coin). The chance of receiving TMS or sham-TMS is equal. They will be enrolled in either the TMS or sham-TMS group (both groups involve 5 TMS or sham-TMS sessions). The study doctor and the participant will not know whether they are in the TMS or sham-TMS group. The purpose of this study is to determine if TMS is a potential treatment for methamphetamine use disorder. TMS is a non-invasive technique that uses magnetic pulses to temporarily stimulate specific brain areas in awake people (without the need for surgery, anesthetic, or other invasive procedures). This study will test whether a specific type of TMS (intermittent theta burst) over the forehead can produce a reduction in things that may prompt you to want to use methamphetamines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcranial Magnetic Stimulation (TMS) | Experimental | This arm receives the TMS treatments. |
|
| Sham-TMS | Sham Comparator | This arm receives sham TMS treatments. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Magnetic Stimulation | Device | Transcranial Magnetic Stimulation (TMS using Intermittent theta burst stimulation (iTBS) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Generalized Anxiety Disorder-7 (GAD-7) | Self-rated anxiety severity | Screening/Visit1 and day 5 of iTBS/Sham TMS |
| Patient Health Questionnaire-9 (PHQ-9) | self-rated depression severity |
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Inclusion Criteria:
Exclusion Criteria:
- Individuals currently struggling with alcohol use and/or benzodiazepine use
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sooraj John, M.D. | Contact | 540-981-7000 | research@carilionclinic.org | |
| Maryann Hollen, B.S. | Contact | 540-566-8081 | research@carilionclinic.org |
| Name | Affiliation | Role |
|---|---|---|
| Sooraj John, M.D. | Carilion Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carilion Clinic | Recruiting | Roanoke | Virginia | 24014 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. | |
| 35558419 | Background |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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Participants will be randomized to either receive 5 transcranial magnetic stimulations or 5 sham transcranial magnetic stimulation (no therapeutic levels of stimulation) sessions.
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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.
|
| Sham Transcranial Magnetic Stimulation | Device | Participants will not receive intermittent theta burst stimulation during the sham-TMS sessions |
|
|
| Screening/Visit 1 and day 5 of iTBS/Sham TMS |
| Quality - Life Enjoyment Scale - Questionnaire (Q-LES-Q) | Self-rated Quality of Life scale | 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) | Clinician rated anxiety | 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) | Clinician rated depression | 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 |
| Clinical Global Impression - Severity (CGI-S) | Clinician rated illness severity | Screening/Visit 1 |
| Clinical Global Impression - Improvement (CGI-I) | Clinician rated illness improvement | 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 |
| 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. |
| 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. |
| 34925101 | 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. |
| 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. |
| 28686990 | 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. |
| 28410525 | 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. |
| 32252538 | 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. |