The Diagnostic Assessment and Intervention Study of Amphetamine Type Stimulus

NCT ID: NCT02285556

Last Updated: 2015-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

560 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2014-11-30

Brief Summary

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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

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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.

Conditions

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Amphetamine Addiction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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general information

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

ATS diagnosis and evaluation for abusers

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

psychological training intervention

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.

Group Type ACTIVE_COMPARATOR

psychological rehabilitation training

Intervention Type BEHAVIORAL

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.

brain stimulation intervention

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.

Group Type ACTIVE_COMPARATOR

rTMS 10HZ high frequency stimulation

Intervention Type RADIATION

Stimulate the dorsolateral prefrontal and parietal lower part , 4 weeks of therapeutic intervention (5 times / week).

ATS diagnosis and evaluation for normal people

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 .

Group Type NO_INTERVENTION

No interventions assigned to this group

physical and neurological rehabilitation

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 .

Group Type ACTIVE_COMPARATOR

physical and neurological rehabilitation training

Intervention Type BEHAVIORAL

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 brain stimulation intervention

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

Group Type PLACEBO_COMPARATOR

fake rTMS 10HZ high frequency stimulation

Intervention Type RADIATION

Fake stimulate the dorsolateral prefrontal and parietal lower part , 4 weeks of therapeutic intervention (5 times / week).

Interventions

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psychological rehabilitation training

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

physical and neurological rehabilitation training

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 BEHAVIORAL

rTMS 10HZ high frequency stimulation

Stimulate the dorsolateral prefrontal and parietal lower part , 4 weeks of therapeutic intervention (5 times / week).

Intervention Type RADIATION

fake rTMS 10HZ high frequency stimulation

Fake stimulate the dorsolateral prefrontal and parietal lower part , 4 weeks of therapeutic intervention (5 times / week).

Intervention Type RADIATION

Eligibility Criteria

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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 .
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Mental Health Center

OTHER

Sponsor Role lead

Responsible Party

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Min ZHAO

Vice President

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Min Zhao, ph.D.

Role: PRINCIPAL_INVESTIGATOR

Shanghai Mental Health Center

Locations

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Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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MZhao-003

Identifier Type: -

Identifier Source: org_study_id