Evaluation of the Effect of Repetitive Transcranial Magnetic Stimulation in Craving in Methamphetamine Use Disorder
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 144
- Locations
- 1
- Primary Endpoint
- Change of Craving assessed by Visual Analog Scale
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
control group
Sham TBS delivered on left dlPFC or medial prefrontal cortex of amphetamine-dependent patients. Stimulation pulses are the same as the real group.
Intervention: sham TBS (Device)
real mPFC cTBS group
The real cTBS stimulation pattern will be delivered on the medial prefrontal cortex.
Intervention: real mPFC cTBS (Device)
real dlPFC iTBS group
The real iTBS stimulation pattern will be delivered on the left dorsal prefrontal cortex.
Intervention: real dlPFC iTBS (Device)
real dlPFC iTBS + real mPFC cTBS group
Combination therapy of real iTBS stimulation delivered on the left dorsal prefrontal cortex and real cTBS stimulation delivered on the medial prefrontal cortex.
Intervention: real dlPFC iTBS + real mPFC cTBS (Device)
Outcomes
Primary Outcomes
Change of Craving assessed by Visual Analog Scale
Time Frame: 12 months.
evaluate all participants' craving for for methamphetamine assessed by Visual Analog Scales (VAS). Score of VAS range from 0 to 10, and higher values represent high level of craving.
Secondary Outcomes
- Depression status assessed by Patient Health Questionnaire-9(PHQ-9)(12 months)
- Response inhibition function(12 months)
- Anxiety status assessed by Generalized Anxiety Disorder Screener (GAD-7)(12 months)
- Cognitive function assessed by CogState Battery (CSB)(12 months)
- Number of participants who relapse(12 months)
- Cue reactivity(12 months)