Theta Burst TMS for Treatment of Methamphetamine Use Disorder

Methamphetamine Abuse Clinical Trial

Official title:

Theta Burst Transcranial Magnetic Stimulation for the Treatment of Methamphetamine Use Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06372288
• Other study ID #: 22-1754
• Status: Recruiting
• Phase: N/A
• Start date: December 20, 2023
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Carilion Clinic
• Contact: Sooraj John, M.D.
• Phone: 540-981-7000
• Email: research[@]carilionclinic.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Individuals actively struggling with Methamphetamine Use Disorder

• Must be currently enrolled in Carilion Clinic Office Based Addiction Treatment (OBAT) program

Exclusion Criteria:

• Individuals currently struggling with alcohol use and/or benzodiazepine use

Related Conditions & MeSH terms

• Methamphetamine Abuse

Intervention

Device:
• Transcranial Magnetic Stimulation
Transcranial Magnetic Stimulation (TMS using Intermittent theta burst stimulation (iTBS)
• Sham Transcranial Magnetic Stimulation
Participants will not receive intermittent theta burst stimulation during the sham-TMS sessions

Locations

Country	Name	City	State
United States	Carilion Clinic	Roanoke	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Carilion Clinic	Virginia Polytechnic Institute and State University

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	Generalized Anxiety Disorder-7 (GAD-7)	Self-rated anxiety severity	Screening/Visit1 and day 5 of iTBS/Sham TMS
Secondary	Patient Health Questionnaire-9 (PHQ-9)	self-rated depression severity	Screening/Visit 1 and day 5 of iTBS/Sham TMS
Secondary	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
Secondary	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
Secondary	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
Secondary	Clinical Global Impression - Severity (CGI-S)	Clinician rated illness severity	Screening/Visit 1
Secondary	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