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The Diagnostic Assessment and Intervention Study of Amphetamine Type Stimulus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02285556
Recruitment Status : Completed
First Posted : November 7, 2014
Last Update Posted : November 18, 2015
Sponsor:
Information provided by (Responsible Party):
Min ZHAO, Shanghai Mental Health Center

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.

Condition or disease Intervention/treatment Phase
Amphetamine Addiction Behavioral: psychological rehabilitation training Behavioral: physical and neurological rehabilitation training Radiation: rTMS 10HZ high frequency stimulation Radiation: fake rTMS 10HZ high frequency stimulation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 560 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Diagnostic Assessment and Intervention Study of Amphetamine Type Stimulus
Study Start Date : March 2012
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: 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.
No Intervention: 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.
Active Comparator: 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.
Behavioral: 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.

Active Comparator: 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.
Radiation: rTMS 10HZ high frequency stimulation
Stimulate the dorsolateral prefrontal and parietal lower part , 4 weeks of therapeutic intervention (5 times / week).

No Intervention: 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 .
Active Comparator: 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 .
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 .

Placebo Comparator: 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.
Radiation: fake rTMS 10HZ high frequency stimulation
Fake stimulate the dorsolateral prefrontal and parietal lower part , 4 weeks of therapeutic intervention (5 times / week).




Primary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02285556


Locations
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China, Shanghai
Shanghai Mental Health Center
Shanghai, Shanghai, China
Sponsors and Collaborators
Shanghai Mental Health Center
Investigators
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Principal Investigator: Min Zhao, ph.D. Shanghai Mental Health Center
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Responsible Party: Min ZHAO, Vice President, Shanghai Mental Health Center
ClinicalTrials.gov Identifier: NCT02285556    
Other Study ID Numbers: MZhao-003
First Posted: November 7, 2014    Key Record Dates
Last Update Posted: November 18, 2015
Last Verified: November 2015
Keywords provided by Min ZHAO, Shanghai Mental Health Center:
drug carving changes during rehabilitation
community
DNA
Additional relevant MeSH terms:
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Amphetamine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders