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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wei Hao, Central South University
ClinicalTrials.gov Identifier:
NCT01825928
First received: March 28, 2013
Last updated: July 27, 2016
Last verified: July 2016
  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: Randomized, Double-blind, Placebo-controlled Trial of Paliperidone Extended-Release Tablets for Reducing Psychosis Relapse and Craving in Chinese Patients With Methamphetamine Dependence After Detoxification Treatment

Resource links provided by NLM:


Further study details as provided by Central South University:

Primary Outcome Measures:
  • Time (day) to first psychosis relapse from baseline to 84 days [ Time Frame: up to 84 days ] [ Designated as safety issue: Yes ]
    psychosis assessement was made once a week.Psychotic symptom relapse was defined as one or more of the following: (1) hospitalization for psychotic symptoms; deliberate self-injury or violent behavior, or suicidal or homicidal ideation that was clinically significant;25% increase in PANSS total score;for patients who scored >40 at randomization, or a 10-point increase for patients who scored ≤40 at randomization for two consecutive assessments (within 1 week), and (4) increase in prespecified individual PANSS items scores (P1, P2, P3, P6, P7 and G8) to ≥5 for patients whose score was ≤3 at randomization, or to ≥6 for patients whose score was 4 at randomization for two consecutive assessments (within 1 week)


Secondary Outcome Measures:
  • Change from baseline in PANSS total scores at 84 days [ Time Frame: up to 84 days ] [ Designated as safety issue: Yes ]
    psychosis assessment was made by PANSS once a week, and calculated the total scores

  • Change from baseline in CGI-S scores at 84 days [ Time Frame: up to 84 days ] [ Designated as safety issue: Yes ]
    general condition assessment was made by CGI-S once a week, and calculated the total scores

  • Change from baseline in Visual Analogue Scale (VAS) at 84 days [ Time Frame: up to 84 days ] [ Designated as safety issue: Yes ]
    Methamphetamine craving assessment was made by VAS once a week, and calculated the total scores

  • The time-to-first(day) positive methamphetamine urine test [ Time Frame: up to 84 days ] [ Designated as safety issue: Yes ]
    Made urine test once a week at hospital.

  • Treatment Effectiveness Score [ Time Frame: up to 84 days ] [ Designated as safety issue: Yes ]
    The sum of the number of METH-free urine samples submitted per participant

  • longest period of methamphetamine abstinence during the 84 days [ Time Frame: up to 84 days ] [ Designated as safety issue: Yes ]
    Made urine test once a week at hospital.

  • number of treatment day which calculated from randomization to the last visiting point [ Time Frame: up to 84 days ] [ Designated as safety issue: Yes ]
    record the follow up time


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,3mg/pill,3mg/day.last84 days.
Drug: Paliperidone
Paliperidone group,3mg/pill,3mg/day forced titration method,last 84 days
Other Names:
  • Paliperidone Extended-Release Tablets
  • Invega
Placebo Comparator: placebo
placebo group,3mg/pill,3mg/day non-forced titration method,last84 days.
Drug: placebo
placebo group,3mg/pill,3mg/day forced titration method,last 84 days

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

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women aged 18 years to 60 years
  • Met the Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) criteria for METH dependence with psychosis
  • Completing inpatient METH detoxification (≤30 days) with psychotic symptoms disappeared
  • Beoff any anti-psychotic medication for 7 days after discharging from hospital were enrolled at clinical site
  • Participants were interesting in reducing or stopping METH use
  • Every patient also had a significant other (eg., spouse or relative) who supervised their compliance with the visit schedule and study procedures
  • Women of childbearing potential agreed to use contraception during the study.

Exclusion criteria:

  • Pregnancy or breastfeeding;
  • Significant medical conditions (eg., acute renal failure, endocarditis, and tuberculosis); hepatic failure; past or present history of an AIDS-indicator disease; active hepatitis or aspartate amino transferase or alanine aminotransferase more than three times the upper limit of normal
  • Known intolerance or hypersensitivity to paliperidone ER; other psychosis; present dependence on substances other than METH or poly-substance abuse.
  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

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: NCT01825928     History of Changes
Other Study ID Numbers: 100000-068944 
Study First Received: March 28, 2013
Last Updated: July 27, 2016
Health Authority: China: Ethics Committee
China: National Natural Science Foundation
United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Central South University:
Methamphetamine
paliperidone

Additional relevant MeSH terms:
Methamphetamine
Paliperidone Palmitate
Central Nervous System Stimulants
Physiological Effects of Drugs
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
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists

ClinicalTrials.gov processed this record on August 24, 2016