The Diagnostic Assessment and Intervention Study of Amphetamine Type Stimulus

Amphetamine Addiction Clinical Trial

Official title:

The Diagnostic Assessment and Intervention Study of Amphetamine Type Stimulus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02285556
• Other study ID #: MZhao-003
• Status: Completed
• Phase: N/A
• First received: August 19, 2014
• Last updated: November 16, 2015
• Start date: March 2012
• Est. completion date: November 2014

Study information

• Verified date: November 2015
• Source: Shanghai Mental Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 560
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 49 Years

Eligibility

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 .

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Amphetamine Addiction

Intervention

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.
• 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 .

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

Locations

Country	Name	City	State
China	Shanghai Mental Health Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline	No
Primary	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.	Baseline	No