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An Study of Aripiprazole in the Treatment of Methamphetamine Dependence

Sponsor
Wei Hao (Other)
Overall Status
Terminated
CT.gov ID
NCT01813656
Collaborator
(none)
10
Enrollment
1
Location
2
Arms
17
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Methamphetamine substance use is common worldwide. No approved pharmacologic treatments for methamphetamine dependence exist. Aripiprazole are Second generation antipsychotics，but have different pharmacological effects of neurotransmitters.To determine whether mirtazapine would reduce methamphetamine use among mehtamphetamine addicts.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

Methods:A Multiple-Center, Randomized, Double-Blind.

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Multiple-Center, Randomized, Double-Blind Study of Aripiprazole for Treatment of Methamphetamine Dependence
Study Start Date :
Sep 1, 2012
Actual Primary Completion Date :
Dec 1, 2013
Actual Study Completion Date :
Feb 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Aripiprazole

Aripiprazole arm,5mg/pill,10mg/day.last12weeks.

Drug: Aripiprazole
Aripiprazole group,5mg/pill,10mg/day non-forced titration method,last 12weeks
Other Names:
  • Aopai H20041507

    		•
    Placebo Comparator: Sugar pill

    placebo arm,5mg/pill,10mg/day,last12weeks

    Drug: placebo
    placebo group,5mg/pill,10mg/day non-forced titration method,last 12 weeks

    Outcome Measures

    Primary Outcome Measures

    1. abstinent time of Methamphetamine addict [up to 3 months]

      methamphetamine-positive urine test results,self-reports of substance use

    Secondary Outcome Measures

    1. number of Participants with Adverse Events as a Measure of Safety and Tolerability [up to 3 months]

      use Abnormal Involuntary Movement Scale ,Simpson-Angus Scale and Barnes akathisia Scale

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Patients,Diagnostic and Statistical Manual of Mental Disorders 4thed. (DSM-IV) criteria for Methamphetamine dependence.

    2. Must sign a Information consent form.

    3. Required to provide detailed address and phone number

    Exclusion Criteria:

    1. Serious organic disease.

    2. Suicide ideation or hurt others.

    3. Taking antipsychotic within two weeks before.

    4. drug allergy to Risperidone or Aripiprazole.

    5. pregnancy and breastfeeding women.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Second Xiangya Hospital of Central University Changsha Hunan China 410011

    Sponsors and Collaborators

    • Wei Hao

    Investigators

    • Study Director: Wei Hao, MD., Ph.D., Central South University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wei Hao, The Second Xiangya Hospital of Cental South University, Central South University
    ClinicalTrials.gov Identifier:
    NCT01813656
    Other Study ID Numbers:
    • 100000-068942
    First Posted:
    Mar 19, 2013
    Last Update Posted:
    Feb 4, 2015
    Last Verified:
    Feb 1, 2015
    Keywords provided by Wei Hao, The Second Xiangya Hospital of Cental South University, Central South University
    Methamphetamine-Associated Psychosis
    Aripiprazole
    Additional relevant MeSH terms:
    Aripiprazole

    Study Results

    No Results Posted as of Feb 4, 2015