Amphetamine Use Disorders
Conditions
Keywords
Amphetamine-type stimulants, prefrontal-striatal circuits, rTMS, individualized therapy, craving, relapse
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.
Interventions
DEVICEsham TBS
Stimulate the dorsal lateral prefrontal cortex or medial prefrontal cortex for 2 weeks by sham Theta-burst stimulation (TBS), five times for a week with the sham coil.
DEVICEreal mPFC cTBS
Stimulate the medial prefrontal cortex with the cTBS pattern. The therapy will be conducted for 2 weeks and five times for a week.
DEVICEreal dlPFC iTBS
Stimulate the dorsal lateral prefrontal cortex with the iTBS pattern. The therapy will be conducted for 2 weeks and five times for a week.
DEVICEreal dlPFC iTBS + real mPFC cTBS
Stimulate the dorsal lateral prefrontal cortex with the iTBS pattern, and stimulate medial prefrontal cortex with the cTBS pattern. The therapy will be conducted for 2 weeks and five times for a week.
Sponsors
Shanghai Mental Health Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Craving assessed by Visual Analog Scale | 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
| Measure | Time frame | Description |
|---|---|---|
| Depression status assessed by Patient Health Questionnaire-9(PHQ-9) | 12 months | evaluate all participants' depression status by Patient Health Questionnaire-9(PHQ-9), PHQ-9 range from 0 to 27, and higher values represent more severe level of depression. |
| Anxiety status assessed by Generalized Anxiety Disorder Screener (GAD-7) | 12 months | evaluate all participants' anxiety status by Generalized Anxiety Disorder Screener (GAD-7). PHQ-9 range from 0 to 21, and higher values represent more severe level of anxiety. |
| Number of participants who relapse | 12 months | Follow up with patients after discharge, evaluate number of participants who relapse |
| Response inhibition function | 12 months | assessed by Go nogo task under the electroencephalogram recording |
| Cue reactivity | 12 months | assessed by Cue reactivity task under the electroencephalogram recording |
| Cognitive function assessed by CogState Battery (CSB) | 12 months | evaluate all participants' cognitive function by the computerized CogState Battery (CSB) Chinese version |
Countries
China
Outcome results
None listed