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An Study of Aripiprazole in the Treatment of Methamphetamine Dependence

This study has been terminated.
(Aripiprazole arm had obvious adverse reactions,especially akathisia.)
Information provided by (Responsible Party):
Wei Hao, Central South University Identifier:
First received: November 28, 2012
Last updated: February 2, 2015
Last verified: February 2015
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 Intervention Phase
Methamphetamine Dependence Drug: Aripiprazole Drug: placebo Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Wei Hao, Central South University:

Primary Outcome Measures:
  • abstinent time of Methamphetamine addict [ Time Frame: up to 3 months ]
    methamphetamine-positive urine test results,self-reports of substance use

Secondary Outcome Measures:
  • number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: up to 3 months ]
    use Abnormal Involuntary Movement Scale ,Simpson-Angus Scale and Barnes akathisia Scale

Enrollment: 10
Study Start Date: September 2012
Study Completion Date: February 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aripiprazole
Aripiprazole arm,5mg/pill,10mg/day.last12weeks.
Drug: Aripiprazole
Aripiprazole group,5mg/pill,10mg/day non-forced titration method,last 12weeks
Other Name: 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

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

Ages Eligible for Study:   19 Years to 65 Years   (Adult)
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
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Please refer to this study by its identifier: NCT01813656

China, Hunan
The Second Xiangya Hospital of Central University
Changsha, Hunan, China, 410011
Sponsors and Collaborators
Wei Hao
Study Director: Wei Hao, MD., Ph.D. Central South University
  More Information

Responsible Party: Wei Hao, The Second Xiangya Hospital of Cental South University, Central South University Identifier: NCT01813656     History of Changes
Other Study ID Numbers: 100000-068942
Study First Received: November 28, 2012
Last Updated: February 2, 2015

Keywords provided by Wei Hao, Central South University:
Methamphetamine-Associated Psychosis

Additional relevant MeSH terms:
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors processed this record on September 25, 2017