Randomized, Double-blind, Placebo-controlled Trial of Paliperidone Extended-Release Tablets for The Treatment of Methamphetamine Dependence in Chinese Patients After Detoxification
Overview
- Phase
- Not Applicable
- Intervention
- Paliperidone
- Conditions
- Methamphetamine Dependence
- Sponsor
- Wei Hao
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Abstinent time of Methamphetamine addict
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Wei Hao
The Second Xiangya Hospital of Cental South University
Central South University
Eligibility 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
Exclusion Criteria
- Not provided
Arms & Interventions
paliperidone
paliperidone arm,3mg/pill,3mg/day.last84 days.
Intervention: Paliperidone
placebo
placebo group,3mg/pill,3mg/day non-forced titration method,last84 days.
Intervention: placebo
Outcomes
Primary Outcomes
Abstinent time of Methamphetamine addict
Time Frame: 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 Outcomes
- number of treatment day which calculated from randomization to the last visiting point(up to 84 days)
- Change from baseline in Visual Analogue Scale (VAS) at 84 days(up to 84 days)
- Change from baseline in CGI-S scores at 84 days(up to 84 days)
- Time (day) to first psychosis relapse from baseline to 84 days(up to 84 days)