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Clinical Trials/NCT02713815
NCT02713815CompletedNot Applicable

The Repetitive Transcranial Magnetic Stimulation (rTMS) for Amphetamine-type Stimulants Addiction

Shanghai Mental Health Center1 site in 1 country60 target enrollmentStarted: July 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
1
Primary Endpoint
Change from Baseline Craving for ATS assessed by Visual Analog Scales (VAS) at 1 month

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 50 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
  • •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

Arms & Interventions

control group

Sham Comparator

sham repetitive transcranial magnetic stimulation (rTMS) of the left frontal lobe dorsal lateral effect on ATS dependent induced cognitive dysfunction and other symptoms.

Intervention: sham repetitive transcranial magnetic stimulation (rTMS) (Radiation)

rTMS group

Active Comparator

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.

Intervention: repetitive transcranial magnetic stimulation (rTMS) (Radiation)

Outcomes

Primary Outcomes

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

Time Frame: Baseline and 1 month

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

Secondary Outcomes

  • Number of participants who relapse(1 month)
  • Depression status assessed by Patient Health Questionnaire-9(PHQ-9)(1 month)
  • Anxiety status assessed by Generalized Anxiety Disorder Screener (GAD-7)(1 month)
  • Cognitive function assessed by Cogstate Battery(1 month)
  • Functional connectivity assessed by MRI(1 month)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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