Status:
COMPLETED
An Study of Paliperidone Extended-Release Tablets in the Treatment of Methamphetamine Dependence
Lead Sponsor:
Wei Hao
Conditions:
Methamphetamine Dependence
Eligibility:
All Genders
18-65 years
Phase:
NA
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 bloc...
Detailed Description
Methods:A Multiple-Center, Randomized, Double-Blind.
Eligibility Criteria
Inclusion
- 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
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01825928
Start Date
February 1 2013
End Date
July 1 2014
Last Update
July 13 2017
Active Locations (1)
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1
The Second Xiangya Hospital of Central University
Changsha, Hunan, China, 410011