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

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

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.

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

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.