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.

Study Overview

• Status: Completed
• Conditions: Methamphetamine Dependence
• Intervention / Treatment: Drug: Paliperidone; Drug: placebo

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410011
      • The Second XiangYa Hospital Of Central University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: paliperidone; paliperidone arm,3mg/pill,3mg/day.last84 days.	Drug: Paliperidone; Paliperidone group,3mg/pill,3mg/day forced titration method,last 84 days; Other Names: Invega; Paliperidone Extended-Release Tablets
PLACEBO_COMPARATOR: placebo; placebo group,3mg/pill,3mg/day non-forced titration method,last84 days.	Drug: placebo; placebo group,3mg/pill,3mg/day forced titration method,last 84 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
number of treatment day which calculated from randomization to the last visiting point	record the follow up time	up to 84 days

Collaborators and Investigators

• Sponsor: Wei Hao

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (ACTUAL): April 1, 2014
• Study Completion (ACTUAL): July 1, 2014

Study Registration Dates

• First Submitted: March 28, 2013
• First Submitted That Met QC Criteria: April 5, 2013
• First Posted (ESTIMATE): April 8, 2013

Study Record Updates

• Last Update Posted (ACTUAL): July 13, 2017
• Last Update Submitted That Met QC Criteria: July 11, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: paliperidone; Methamphetamine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Paliperidone Palmitate
• Other Study ID Numbers: 100000-068944

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED