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

Not Applicable

Completed

• Conditions: Methamphetamine Dependence
• Interventions: Drug: Paliperidone; Drug: placebo

• Registration Number: NCT01825928
• Lead Sponsor: Wei Hao

Brief Summary

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

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

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-03-28
• Study First Submitted QC: 2013-04-05
• Study First Posted: 2013-04-08
• Primary Completion: 2014-04
• Study Completion: 2014-07
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-11
• Last Update Posted: 2017-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
paliperidone	Paliperidone	paliperidone arm,3mg/pill,3mg/day.last84 days.
placebo	placebo	placebo group,3mg/pill,3mg/day non-forced titration method,last84 days.

Primary Outcome Measures

Name	Time	Method
Abstinent time of Methamphetamine addict	up to 84 days	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Second Xiangya Hospital of Central University; 🇨🇳 Changsha, Hunan, China