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

Methamphetamine Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01825928
• Other study ID #: 100000-068944
• Status: Completed
• Phase: N/A
• First received: March 28, 2013
• Last updated: July 11, 2017
• Start date: February 2013
• Est. completion date: July 2014

Study information

• Verified date: July 2017
• Source: Central South University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Methamphetamine Dependence

Intervention

Drug:
• Paliperidone
Paliperidone group,3mg/pill,3mg/day forced titration method,last 84 days
• placebo
placebo group,3mg/pill,3mg/day forced titration method,last 84 days

Locations

Country	Name	City	State
China	The Second Xiangya Hospital of Central University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Wei Hao

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abstinent time of Methamphetamine addict	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.	up to 84 days
Secondary	Time (day) to first psychosis relapse from baseline to 84 days	psychosis assessement was made once a week.Psychotic symptom relapse was defined as one or more of the following: (1) hospitalization for psychotic symptoms; deliberate self-injury or violent behavior, or suicidal or homicidal ideation that was clinically significant;25% increase in PANSS total score;for patients who scored >40 at randomization, or a 10-point increase for patients who scored =40 at randomization for two consecutive assessments (within 1 week), and (4) increase in prespecified individual PANSS items scores (P1, P2, P3, P6, P7 and G8) to =5 for patients whose score was =3 at randomization, or to =6 for patients whose score was 4 at randomization for two consecutive assessments (within 1 week)	up to 84 days
Secondary	Change from baseline in CGI-S scores at 84 days	general condition assessment was made by CGI-S once a week, and calculated the total scores	up to 84 days
Secondary	Change from baseline in Visual Analogue Scale (VAS) at 84 days	Methamphetamine craving assessment was made by VAS once a week, and calculated the total scores	up to 84 days
Secondary	number of treatment day which calculated from randomization to the last visiting point	record the follow up time	up to 84 days