Clinical trial NCT03736317: Transcranial Magnetic Stimulation for Treatment of Methamphetamine Use Disorder
Official title: Evaluation of the Effect of Repetitive Transcranial Magnetic Stimulation in Craving in Methamphetamine Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amphetamine Use Disorders
Keywords: Amphetamine-type stimulants
prefrontal-striatal circuits
rTMS
individualized therapy
craving
relapse
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2018-11-09
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Repetitive transcranial magnetic stimulation (rTMS) was used to treat methamphetamine use disorder in previous studies, while the evidence-based protocols still required. The aim of this research is to develop more applicable rTMS intervention pattern and protocols to reduce craving and relapse of methamphetamine-dependent patients.

Detailed description: The limbic circuit and executive control circuit are two important frontal-striatal neural circuits associated with drug dependence. Previous studies showed increased functional activity within the limbic neural circuit (e.g. medial prefrontal cortex (mPFC) and ventral striatum) in the presence of a salient cue and decreased activity in the executive control circuit (e.g. dorsal prefrontal cortex and dorsal striatum). TMS was used to reverse the activities of these two circuits, by using continuous TBS and intermittent TBS, respectively. In this study, vmPFC cTBS was conducted to modulating the limbic circuit, while left dlPFC iTBS was conducted to modulating the executive control circuit. Combined treatment of vmPFC cTBS and left dlPFC iTBS was conducted to modulating two circuits simultaneously. Focused on evaluating the efficacy of the interventions and investigate the mechanisms, neuropsychological tests, biochemical tests, and electroencephalography will be used to investigate the neurobiological mechanism of the methamphetamine use disorder, craving, and relapse. The study will be very helpful to develop evidence-based rTMS protocols for methamphetamine-dependent patients in clinical practice and decrease harm for both the patients and their families.

Eligibility criteria: Inclusion Criteria:

* In accordance with the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) for methamphetamine (MA) use disorders
* Primary school degree or above
* Normal vision and hearing
* Dextromanual
* Less than one month before last drug use

Exclusion Criteria:

* Have a disease that affect cognitive function such as history of head injury, cerebrovascular disease, epilepsy, etc
* Have cognitive-promoting drugs in the last 6 months
* Other substance abuse or dependence in recent five years (except nicotine)
* Mental impairment, Intelligence Quotient (IQ) \< 70
* Mental disorders
* Physical disease

Primary outcomes:
measure: Change of Craving assessed by Visual Analog Scale
timeFrame: 12 months.
Secondary outcomes:
measure: Number of participants who relapse
timeFrame: 12 months
measure: Depression status assessed by Patient Health Questionnaire-9(PHQ-9)
timeFrame: 12 months
measure: Anxiety status assessed by Generalized Anxiety Disorder Screener (GAD-7)
timeFrame: 12 months
measure: Cognitive function assessed by CogState Battery (CSB)
timeFrame: 12 months
measure: Response inhibition function
timeFrame: 12 months
measure: Cue reactivity
timeFrame: 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Compulsory Rehabilitation Center
state: Shanghai
Study officials:
affiliation: Shanghai Mental Health Center
name: Min Zhao, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.