An Study of Aripiprazole in the Treatment of Methamphetamine Dependence

Phase 4

Terminated

• Conditions: Methamphetamine Dependence
• Interventions: Drug: Aripiprazole; Drug: placebo

• Registration Number: NCT01813656
• Lead Sponsor: Wei Hao

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.

Detailed Description

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

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-11-28
• Study First Submitted QC: 2013-03-15
• Study First Posted: 2013-03-19
• Primary Completion: 2013-12
• Study Completion: 2014-02
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-02
• Last Update Posted: 2015-02-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aripiprazole	Aripiprazole	Aripiprazole arm,5mg/pill,10mg/day.last12weeks.
Sugar pill	placebo	placebo arm,5mg/pill,10mg/day,last12weeks

Primary Outcome Measures

Name	Time	Method
abstinent time of Methamphetamine addict	up to 3 months	methamphetamine-positive urine test results,self-reports of substance use

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The Second Xiangya Hospital of Central University; 🇨🇳 Changsha, Hunan, China