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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02713815
Other study ID # Mzhao-004
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2016
Est. completion date July 2019

Study information

Verified date November 2019
Source Shanghai Mental Health Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date July 2019
Est. primary completion date July 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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

Study Design


Intervention

Radiation:
repetitive transcranial magnetic stimulation (rTMS)
Stimulate the dorsomedial prefrontal cortex for 4 weeks by Theta-burst stimulation (TBS), once a day
sham repetitive transcranial magnetic stimulation (rTMS)
Stimulate the dorsomedial prefrontal cortex for 4 weeks by sham Theta-burst stimulation (TBS), once a day

Locations

Country Name City State
China Shanghai Gaojing Rehabilitation Center Shanghai Shanghai

Sponsors (2)

Lead Sponsor Collaborator
Shanghai Mental Health Center Yunnan Institute For Drug Abuse

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) Baseline and 1 month
Secondary Number of participants who relapse Follow up with patients after discharge, evaluate number of participants who relapse 1 month
Secondary Depression status assessed by Patient Health Questionnaire-9(PHQ-9) evaluate all participants' depression status by Patient Health Questionnaire-9(PHQ-9) 1 month
Secondary Anxiety status assessed by Generalized Anxiety Disorder Screener (GAD-7) evaluate all participants' anxiety status by Generalized Anxiety Disorder Screener (GAD-7) 1 month
Secondary Cognitive function assessed by Cogstate Battery evaluate all participants' cognition by Cogstate Battery Chinese version 1 month
Secondary Functional connectivity assessed by MRI evaluate all participants' functional connectivity in the brain by MRI 1 month
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