Novel Intervention for Amphetamine-type Stimulants Addiction

Not Applicable

Completed

• Conditions: Amphetamine Addiction
• Interventions: Radiation: repetitive transcranial magnetic stimulation (rTMS); Radiation: sham repetitive transcranial magnetic stimulation (rTMS)

• Registration Number: NCT02713815
• Lead Sponsor: Shanghai Mental Health Center

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2016-03-07
• Study First Submitted QC: 2016-03-15
• Study First Posted: 2016-03-21
• Study Start: 2016-07
• Primary Completion: 2019-07
• Study Completion: 2019-07
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-30
• Last Update Posted: 2019-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rTMS group	repetitive transcranial magnetic stimulation (rTMS)	Use randomized, prospective pseudo stimulus controlled clinical trial design, evaluation of repetitive transcranial magnetic stimulation of the left frontal lobe dorsal lateral effect on ATS dependent induced cognitive dysfunction and other symptoms.
control group	sham repetitive transcranial magnetic stimulation (rTMS)	sham repetitive transcranial magnetic stimulation (rTMS) of the left frontal lobe dorsal lateral effect on ATS dependent induced cognitive dysfunction and other symptoms.

Primary Outcome Measures

Name	Time	Method
Change from Baseline Craving for ATS assessed by Visual Analog Scales (VAS) at 1 month	Baseline and 1 month	evaluate all participants' craving for ATS by Visual Analog Scales (VAS)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shanghai Gaojing Rehabilitation Center; 🇨🇳 Shanghai, Shanghai, China