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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Central South University
Sponsor:
Information provided by (Responsible Party):
Wei Hao, Central South University
ClinicalTrials.gov Identifier:
NCT01825928
First received: March 28, 2013
Last updated: April 5, 2013
Last verified: April 2013
  Purpose

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)


Estimated Enrollment: 100
Study Start Date: February 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: February 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
Other Name: placebo

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
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 paliperidone.
  5. pregnancy and breastfeeding women.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01825928

Contacts
Contact: Gang Wang, doctor 18684667092 visa8752@yahoo.com.cn

Locations
China, Hunan
The Second Xiangya Hospital of Central University Recruiting
Changsha, Hunan, China, 410011
Contact: Gang Wang, doctor    18684667092    visa8752@yahoo.com.cn   
Principal Investigator: Gang Wang, doctor         
Sponsors and Collaborators
Wei Hao
Investigators
Study Director: Wei Hao, MD., Ph.D. Central South University
  More Information

No publications provided

Responsible Party: Wei Hao, The Second Xiangya Hospital of Cental South University, Central South University
ClinicalTrials.gov Identifier: NCT01825928     History of Changes
Other Study ID Numbers: 100000-068944
Study First Received: March 28, 2013
Last Updated: April 5, 2013
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
paliperidone

Additional relevant MeSH terms:
Methamphetamine
9-hydroxy-risperidone
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 28, 2014