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

Study Overview
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Brief Summary
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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.

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

Official Title
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Randomized, Double-blind, Placebo-controlled Trial of Paliperidone Extended-Release Tablets for The Treatment of Methamphetamine Dependence in Chinese Patients After Detoxification

Conditions
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Methamphetamine Dependence

Intervention / Treatment
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* Drug: Paliperidone
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: paliperidone<br>paliperidone arm,3mg/pill,3mg/day.last84 days. | Drug: Paliperidone<br>* Paliperidone group,3mg/pill,3mg/day forced titration method,last 84 days<br>* Other names: Invega;|
| Placebo Comparator: placebo<br>placebo group,3mg/pill,3mg/day non-forced titration method,last84 days. | Drug: placebo<br>* placebo group,3mg/pill,3mg/day forced titration method,last 84 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abstinent time of Methamphetamine addict | The outcome was the confirmed abstinence during 12 weeks. Confirmed abstinence was defined as a negative urine drug test. The following aggregate measures of urine drug test results were calculated: the time-to-first positive urine test, the Treatment Effectiveness Score (TES; the sum of the number of METH-free urine samples submitted per participant ), the longest period of MA abstinence during the 84 days. | up to 84 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time (day) to first psychosis relapse from baseline to 84 days | 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) | up to 84 days | 
| Change from baseline in CGI-S scores at 84 days | general condition assessment was made by CGI-S once a week, and calculated the total scores | up to 84 days | 
| Change from baseline in Visual Analogue Scale (VAS) at 84 days | Methamphetamine craving assessment was made by VAS once a week, and calculated the total scores | up to 84 days | 
| number of treatment day which calculated from randomization to the last visiting point | record the follow up time | up to 84 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Methamphetamine, paliperidone