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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.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01813656
First Posted: March 19, 2013
Last Update Posted: February 4, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Wei Hao, Central South University
  Purpose
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.
  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01813656


Locations
China, Hunan
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
  More Information

Responsible Party: Wei Hao, The Second Xiangya Hospital of Cental South University, Central South University
ClinicalTrials.gov Identifier: NCT01813656     History of Changes
Other Study ID Numbers: 100000-068942
First Submitted: November 28, 2012
First Posted: March 19, 2013
Last Update Posted: February 4, 2015
Last Verified: February 2015

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

Additional relevant MeSH terms:
Aripiprazole
Methamphetamine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Stimulants
Sympathomimetics
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