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

Wei Hao

Status

Completed

Conditions

Methamphetamine Dependence

Treatments

Drug: Paliperidone

Drug: placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01825928

100000-068944

Details and patient eligibility

About

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.

Full description

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

Enrollment

80 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.