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The Diagnostic Assessment and Intervention Study of Amphetamine Type Stimulus

Primary Purpose

Amphetamine Addiction

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
psychological rehabilitation training
physical and neurological rehabilitation training
rTMS 10HZ high frequency stimulation
fake rTMS 10HZ high frequency stimulation
Sponsored by
Shanghai Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Amphetamine Addiction focused on measuring drug carving changes during rehabilitation, community, DNA

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • No previous history of any mental disorder meet the DSM-IV diagnosis
  • aged 18-49 years old , men and women
  • junior high school or higher education
  • use of amphetamine-type substances time for more than one year
  • cumulative use of amphetamines, substances dose of 50 grams or more.

Exclusion Criteria:

  • Current or past had suffered neurological diseases
  • exclusion of antisocial personality disorder and borderline personality disorder
  • addicts in addition to other substances in tobacco , coffee, social drinking outside
  • AIDS virus (HIV) detection positive patients .

Sites / Locations

  • Shanghai Mental Health Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

No Intervention

No Intervention

Active Comparator

Active Comparator

No Intervention

Active Comparator

Placebo Comparator

Arm Label

general information

ATS diagnosis and evaluation for abusers

psychological training intervention

brain stimulation intervention

ATS diagnosis and evaluation for normal people

physical and neurological rehabilitation

fake brain stimulation intervention

Arm Description

use cross-sectional study to collect 1000 ATS abuse or dependence patients' general information and 5 ml blood,get their blood plasma and DNA sample in order to explore the possible addict mechanism.

Use cohort study design to establish ATS abuse induced craving experiment.Do the initial and follow-up assessment from start smoking to stop smoking after 4 weeks, 12 weeks, 26 weeks, 52 weeks and 26 weeks of returning to the community . Thus compare with normal group to explore the possible psychological abuse mechanism.

The main content is self-awareness training, social and moral strengthening, impulse control training , problem solving training , situational awareness training , HIV prevention, social skills training under the family atmosphere , family social skills training , interpersonal skills training, community interaction skills training , psychiatric symptoms of self-monitoring skills training and so on.

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.

Do the same initial and follow-up assessment as ATS abusers who stop smoking after 4 weeks, 12 weeks, 26 weeks, 52 weeks and 26 weeks of returning to the community .

The main content is drug rehabilitation exercise and functional physical training. Rehabilitation led by the discipline cadres , practice once a day, each lasting about 15 minutes .

fake transcranial magnetic stimulation of the left frontal lobe dorsal lateral effect on ATS dependent induced cognitive dysfunction and other symptoms.

Outcomes

Primary Outcome Measures

the prevalence of ATS abuse or dependence characteristics and pathogenesis
Plasma and DNA samples were collected to carry out the biochemical genetics and immunology research of ATS abuse or dependence , and to explore the prevalence of ATS abuse or dependence characteristics and pathogenesis.
the physiological psychology and cognitive impairment characteristic of ATS addicts,trends and ATS conducted cases.
Use repeatable battery for the assessment of neuropsychological status(RBANS),Cog-state cognitive function assessment test,event-related potentials(ERPs),functional magnetic resonance imaging(fMRI) in biology ( molecular genetics, blood biochemistry, electrophysiology , imaging ) , psychology, mental health and other aspects of the system to assess the physiological psychology and cognitive impairment characteristic of ATS addicts , trends and ATS conducted cases.

Secondary Outcome Measures

Full Information

First Posted
August 19, 2014
Last Updated
November 16, 2015
Sponsor
Shanghai Mental Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT02285556
Brief Title
The Diagnostic Assessment and Intervention Study of Amphetamine Type Stimulus
Official Title
The Diagnostic Assessment and Intervention Study of Amphetamine Type Stimulus
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Mental Health Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this research is to inspire new medical ideas using brain image technology for the treatment of Amphetamine Type Stimulus addition, at the same time lowing the addition damage.
Detailed Description
The study will increase the sample size based on the preliminary work,also, establish drug dependence induced craving associated environmental experiments , by using the multi-lead biofeedback instrument , CogState tester, event-related potentials Recorder and 3.0T high-field magnetic resonance imaging system to record the physiology , electrophysiology and brain changes during craving, taking a subjective self-assessment , clinical observations and physiological responses combined system to evaluate the ATS addiction degree.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amphetamine Addiction
Keywords
drug carving changes during rehabilitation, community, DNA

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
560 (Actual)

8. Arms, Groups, and Interventions

Arm Title
general information
Arm Type
No Intervention
Arm Description
use cross-sectional study to collect 1000 ATS abuse or dependence patients' general information and 5 ml blood,get their blood plasma and DNA sample in order to explore the possible addict mechanism.
Arm Title
ATS diagnosis and evaluation for abusers
Arm Type
No Intervention
Arm Description
Use cohort study design to establish ATS abuse induced craving experiment.Do the initial and follow-up assessment from start smoking to stop smoking after 4 weeks, 12 weeks, 26 weeks, 52 weeks and 26 weeks of returning to the community . Thus compare with normal group to explore the possible psychological abuse mechanism.
Arm Title
psychological training intervention
Arm Type
Active Comparator
Arm Description
The main content is self-awareness training, social and moral strengthening, impulse control training , problem solving training , situational awareness training , HIV prevention, social skills training under the family atmosphere , family social skills training , interpersonal skills training, community interaction skills training , psychiatric symptoms of self-monitoring skills training and so on.
Arm Title
brain stimulation intervention
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.
Arm Title
ATS diagnosis and evaluation for normal people
Arm Type
No Intervention
Arm Description
Do the same initial and follow-up assessment as ATS abusers who stop smoking after 4 weeks, 12 weeks, 26 weeks, 52 weeks and 26 weeks of returning to the community .
Arm Title
physical and neurological rehabilitation
Arm Type
Active Comparator
Arm Description
The main content is drug rehabilitation exercise and functional physical training. Rehabilitation led by the discipline cadres , practice once a day, each lasting about 15 minutes .
Arm Title
fake brain stimulation intervention
Arm Type
Placebo Comparator
Arm Description
fake transcranial magnetic stimulation of the left frontal lobe dorsal lateral effect on ATS dependent induced cognitive dysfunction and other symptoms.
Intervention Type
Behavioral
Intervention Name(s)
psychological rehabilitation training
Intervention Description
The main content is self-awareness training, social and moral strengthening, impulse control training , problem solving training , situational awareness training , HIV prevention, social skills training under the family atmosphere , family social skills training , interpersonal skills training, community interaction skills training , psychiatric symptoms of self-monitoring skills training and so on.
Intervention Type
Behavioral
Intervention Name(s)
physical and neurological rehabilitation training
Intervention Description
The main content is drug rehabilitation exercise and functional physical training. Rehabilitation led by the discipline cadres , practice once a day, each lasting about 15 minutes .
Intervention Type
Radiation
Intervention Name(s)
rTMS 10HZ high frequency stimulation
Intervention Description
Stimulate the dorsolateral prefrontal and parietal lower part , 4 weeks of therapeutic intervention (5 times / week).
Intervention Type
Radiation
Intervention Name(s)
fake rTMS 10HZ high frequency stimulation
Intervention Description
Fake stimulate the dorsolateral prefrontal and parietal lower part , 4 weeks of therapeutic intervention (5 times / week).
Primary Outcome Measure Information:
Title
the prevalence of ATS abuse or dependence characteristics and pathogenesis
Description
Plasma and DNA samples were collected to carry out the biochemical genetics and immunology research of ATS abuse or dependence , and to explore the prevalence of ATS abuse or dependence characteristics and pathogenesis.
Time Frame
Baseline
Title
the physiological psychology and cognitive impairment characteristic of ATS addicts,trends and ATS conducted cases.
Description
Use repeatable battery for the assessment of neuropsychological status(RBANS),Cog-state cognitive function assessment test,event-related potentials(ERPs),functional magnetic resonance imaging(fMRI) in biology ( molecular genetics, blood biochemistry, electrophysiology , imaging ) , psychology, mental health and other aspects of the system to assess the physiological psychology and cognitive impairment characteristic of ATS addicts , trends and ATS conducted cases.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: No previous history of any mental disorder meet the DSM-IV diagnosis aged 18-49 years old , men and women junior high school or higher education use of amphetamine-type substances time for more than one year cumulative use of amphetamines, substances dose of 50 grams or more. Exclusion Criteria: Current or past had suffered neurological diseases exclusion of antisocial personality disorder and borderline personality disorder addicts in addition to other substances in tobacco , coffee, social drinking outside AIDS virus (HIV) detection positive patients .
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min Zhao, ph.D.
Organizational Affiliation
Shanghai Mental Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Mental Health Center
City
Shanghai
State/Province
Shanghai
Country
China

12. IPD Sharing Statement

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The Diagnostic Assessment and Intervention Study of Amphetamine Type Stimulus

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