NCT02285556

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
560

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

August 19, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 7, 2014

Completed
Last Updated

November 18, 2015

Status Verified

November 1, 2015

Enrollment Period

2.7 years

First QC Date

August 19, 2014

Last Update Submit

November 16, 2015

Conditions

Amphetamine Addiction

Keywords

drug carving changes during rehabilitationcommunityDNA

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (7)

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.

Behavioral: psychological rehabilitation training

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.

Radiation: rTMS 10HZ high frequency stimulation

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 .

Behavioral: physical and neurological rehabilitation training

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.

Radiation: fake rTMS 10HZ high frequency stimulation

Interventions

psychological rehabilitation trainingBEHAVIORAL

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.

psychological training intervention
physical and neurological rehabilitation trainingBEHAVIORAL

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 .

physical and neurological rehabilitation
rTMS 10HZ high frequency stimulationRADIATION

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

brain stimulation intervention
fake rTMS 10HZ high frequency stimulationRADIATION

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

fake brain stimulation intervention

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Amphetamine-Related Disorders

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Officials

  • Min Zhao, ph.D.

    Shanghai Mental Health Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice President

Study Record Dates

First Submitted

August 19, 2014

First Posted

November 7, 2014

Study Start

March 1, 2012

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

November 18, 2015

Record last verified: 2015-11

Locations

CN(1)