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

NCT ID: NCT01825928

Last Updated: 2017-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2014-07-31

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.

Conditions

Methamphetamine Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

paliperidone

paliperidone arm,3mg/pill,3mg/day.last84 days.

Group Type: EXPERIMENTAL

Paliperidone

Intervention Type: DRUG

Paliperidone group,3mg/pill,3mg/day forced titration method,last 84 days

placebo

placebo group,3mg/pill,3mg/day non-forced titration method,last84 days.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

placebo group,3mg/pill,3mg/day forced titration method,last 84 days

Interventions

Paliperidone

Paliperidone group,3mg/pill,3mg/day forced titration method,last 84 days

Intervention Type: DRUG

placebo

placebo group,3mg/pill,3mg/day forced titration method,last 84 days

Intervention Type: DRUG

Other Intervention Names

Paliperidone Extended-Release Tablets; Invega

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
• Known intolerance or hypersensitivity to paliperidone ER; other psychosis; present dependence on substances other than METH or poly-substance abuse.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wei Hao

OTHER

Sponsor Role: lead

Responsible Party

Wei Hao

The Second Xiangya Hospital of Cental South University

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Wei Hao, MD., Ph.D.

Role: STUDY_DIRECTOR

Central South University

Locations

The Second Xiangya Hospital of Central University

Changsha, Hunan, China

Countries

China

Other Identifiers

100000-068944

Identifier Type: -

Identifier Source: org_study_id