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Clinical Trials/NCT02285556
NCT02285556CompletedNot Applicable

The Diagnostic Assessment and Intervention Study of Amphetamine Type Stimulus

Shanghai Mental Health Center1 site in 1 country560 target enrollmentStarted: March 1, 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
560
Locations
1
Primary Endpoint
the prevalence of ATS abuse or dependence characteristics and pathogenesis

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 49 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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 .

Arms & Interventions

general information

No Intervention

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.

ATS diagnosis and evaluation for abusers

No Intervention

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.

psychological training intervention

Active Comparator

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: psychological rehabilitation training (Behavioral)

brain stimulation intervention

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: rTMS 10HZ high frequency stimulation (Radiation)

ATS diagnosis and evaluation for normal people

No Intervention

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 .

physical and neurological rehabilitation

Active Comparator

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: physical and neurological rehabilitation training (Behavioral)

fake brain stimulation intervention

Placebo Comparator

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

Intervention: fake rTMS 10HZ high frequency stimulation (Radiation)

Outcomes

Primary Outcomes

the prevalence of ATS abuse or dependence characteristics and pathogenesis

Time Frame: Baseline

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.

Time Frame: Baseline

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 Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Min ZHAO

Vice President

Shanghai Mental Health Center

Study Sites (1)

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