Novel Intervention for Amphetamine-type Stimulants Addiction

Shanghai Mental Health Center60 enrolled

Overview

The repetitive transcranial magnetic stimulation (rTMS) will be used to treat amphetamine-type stimulant (ATS) addiction.

The Glutamate and GABA deficits in prefrontal cortex play a vital role in ATS addiction and relapse, and proposed repetitive transcranial magnetic stimulation (rTMS) as a novel interventions. Focused on evaluating Glutamate/GABA functions in prefrontal cortex and functional connectivity with deep brain regions, neuropsychological tests, biochemical tests, magnetic resonance spectroscopy (MRS) and functional MRI will be used to investigate the neurobiological mechanism of ATS addiction and relapse. These methods will also be used to evaluate the efficacy of the novel intervention and investigate the mechanisms. The study will be very helpful to develop novel interventions in clinical practice and decrease ATS-related harm for both the patients and their families.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Amphetamine Addiction

Interventions

repetitive transcranial magnetic stimulation (rTMS)RADIATION

Stimulate the dorsomedial prefrontal cortex for 4 weeks by Theta-burst stimulation (TBS), once a day

sham repetitive transcranial magnetic stimulation (rTMS)RADIATION

Stimulate the dorsomedial prefrontal cortex for 4 weeks by sham Theta-burst stimulation (TBS), once a day

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * In accordance with the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) for methamphetamine (MA) use disorders * Dextromanual 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

Locations (1)

Shanghai Gaojing Rehabilitation Center

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Change from Baseline Craving for ATS assessed by Visual Analog Scales (VAS) at 1 month

evaluate all participants' craving for ATS by Visual Analog Scales (VAS)

Time frame: Baseline and 1 month

Secondary Outcomes

Number of participants who relapse

Follow up with patients after discharge, evaluate number of participants who relapse

Time frame: 1 month

Depression status assessed by Patient Health Questionnaire-9(PHQ-9)

evaluate all participants' depression status by Patient Health Questionnaire-9(PHQ-9)

Time frame: 1 month

Anxiety status assessed by Generalized Anxiety Disorder Screener (GAD-7)

evaluate all participants' anxiety status by Generalized Anxiety Disorder Screener (GAD-7)

Time frame: 1 month

Cognitive function assessed by Cogstate Battery

evaluate all participants' cognition by Cogstate Battery Chinese version

Time frame: 1 month

Functional connectivity assessed by MRI

evaluate all participants' functional connectivity in the brain by MRI

Time frame: 1 month

Data from ClinicalTrials.gov

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