An Study of Paliperidone Extended-Release Tablets in the Treatment of Methamphetamine Dependence

This study has been completed.
Information provided by (Responsible Party):
Wei Hao, Central South University Identifier:
First received: March 28, 2013
Last updated: February 2, 2015
Last verified: February 2015
Methamphetamine substance use is common worldwide. No approved pharmacologic treatments for methamphetamine dependence exist. paliperidone are Second generation antipsychotics,and have effects of blocking dopamine2(D2) and 5-hydroxytryptamine 2A(5-HT) receptors neurotransmitters.To determine whether mirtazapine would reduce methamphetamine use among methamphetamine addicts.

Condition Intervention Phase
Methamphetamine Dependence
Drug: Paliperidone
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multiple-Center, Randomized, Double-Blind Study of Paliperidone Extended-Release Tablets for Treatment of Methamphetamine Dependence

Resource links provided by NLM:

Further study details as provided by Central South University:

Primary Outcome Measures:
  • abstinent time of Methamphetamine addict [ Time Frame: up to 3 months ] [ Designated as safety issue: Yes ]
    duration days of methamphetamine-negative urine test results.

Secondary Outcome Measures:
  • number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: up to 3 months ] [ Designated as safety issue: Yes ]
    The number of people who assessed by Abnormal Involuntary Movement Scale ,Simpson-Angus Scale and Barnes akathisia Scale and at least one scale score is greater than 1.

  • General severity of Methamphetamine addict [ Time Frame: up to 3 months ] [ Designated as safety issue: Yes ]
    Change in score of Brief Symptom Inventory(BSA)

  • Irritability severity of Methamphetamine addict [ Time Frame: up to 3 months ] [ Designated as safety issue: Yes ]
    Change in score of Irritability,Depression and Anxiety Scale (IDA)

Enrollment: 80
Study Start Date: February 2013
Study Completion Date: July 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: paliperidone
paliperidone arm,6mg/pill,6-12mg/day.last12weeks.
Drug: Paliperidone
Paliperidone group,6mg/pill,6-12mg/day non-forced titration method,last 12weeks
Other Names:
  • Paliperidone Extended-Release Tablets
  • Invega
Placebo Comparator: placebo
placebo group,6mg/pill,6-12mg/day non-forced titration method,last 12 weeks
Drug: placebo
placebo group,6mg/pill,6-12mg/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)
Genders Eligible for Study:   Both
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 paliperidone.
  5. pregnancy and breastfeeding women.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01825928

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: NCT01825928     History of Changes
Other Study ID Numbers: 100000-068944 
Study First Received: March 28, 2013
Last Updated: February 2, 2015
Health Authority: China: Ethics Committee
China: National Natural Science Foundation
United States: Food and Drug Administration

Keywords provided by Central South University:
Methamphetamine-Associated Psychosis

Additional relevant MeSH terms:
Paliperidone Palmitate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents
Central Nervous System Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors processed this record on July 24, 2016