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Novel Intervention for Amphetamine-type Stimulants Addiction

Primary Purpose

Amphetamine Addiction

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
repetitive transcranial magnetic stimulation (rTMS)
sham repetitive transcranial magnetic stimulation (rTMS)
Sponsored by
Shanghai Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amphetamine Addiction focused on measuring Amphetamine-type stimulants, prefrontal-striatal circuits, rTMS, Glutamate/GABA, motivational and cognitive intervention

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Shanghai Gaojing Rehabilitation Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

control group

rTMS group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
March 7, 2016
Last Updated
November 30, 2019
Sponsor
Shanghai Mental Health Center
Collaborators
Yunnan Institute For Drug Abuse
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1. Study Identification

Unique Protocol Identification Number
NCT02713815
Brief Title
Novel Intervention for Amphetamine-type Stimulants Addiction
Official Title
The Repetitive Transcranial Magnetic Stimulation (rTMS) for Amphetamine-type Stimulants Addiction
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
July 2019 (Actual)
Study Completion Date
July 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Mental Health Center
Collaborators
Yunnan Institute For Drug Abuse

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amphetamine Addiction
Keywords
Amphetamine-type stimulants, prefrontal-striatal circuits, rTMS, Glutamate/GABA, motivational and cognitive intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Sham Comparator
Arm Description
sham repetitive transcranial magnetic stimulation (rTMS) of the left frontal lobe dorsal lateral effect on ATS dependent induced cognitive dysfunction and other symptoms.
Arm Title
rTMS group
Arm Type
Active Comparator
Arm Description
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 Type
Radiation
Intervention Name(s)
repetitive transcranial magnetic stimulation (rTMS)
Intervention Description
Stimulate the dorsomedial prefrontal cortex for 4 weeks by Theta-burst stimulation (TBS), once a day
Intervention Type
Radiation
Intervention Name(s)
sham repetitive transcranial magnetic stimulation (rTMS)
Intervention Description
Stimulate the dorsomedial prefrontal cortex for 4 weeks by sham Theta-burst stimulation (TBS), once a day
Primary Outcome Measure Information:
Title
Change from Baseline Craving for ATS assessed by Visual Analog Scales (VAS) at 1 month
Description
evaluate all participants' craving for ATS by Visual Analog Scales (VAS)
Time Frame
Baseline and 1 month
Secondary Outcome Measure Information:
Title
Number of participants who relapse
Description
Follow up with patients after discharge, evaluate number of participants who relapse
Time Frame
1 month
Title
Depression status assessed by Patient Health Questionnaire-9(PHQ-9)
Description
evaluate all participants' depression status by Patient Health Questionnaire-9(PHQ-9)
Time Frame
1 month
Title
Anxiety status assessed by Generalized Anxiety Disorder Screener (GAD-7)
Description
evaluate all participants' anxiety status by Generalized Anxiety Disorder Screener (GAD-7)
Time Frame
1 month
Title
Cognitive function assessed by Cogstate Battery
Description
evaluate all participants' cognition by Cogstate Battery Chinese version
Time Frame
1 month
Title
Functional connectivity assessed by MRI
Description
evaluate all participants' functional connectivity in the brain by MRI
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhao Min, PhD
Organizational Affiliation
Shanghai Mental Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Gaojing Rehabilitation Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201900
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Novel Intervention for Amphetamine-type Stimulants Addiction

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