NCT01825928

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 8, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

July 13, 2017

Status Verified

July 1, 2017

Enrollment Period

1.2 years

First QC Date

March 28, 2013

Last Update Submit

July 11, 2017

Conditions

Methamphetamine Dependence

Keywords

Methamphetaminepaliperidone

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Time (day) to first psychosis relapse from baseline to 84 days

    up to 84 days

  • Change from baseline in CGI-S scores at 84 days

    up to 84 days

  • Change from baseline in Visual Analogue Scale (VAS) at 84 days

    up to 84 days

  • number of treatment day which calculated from randomization to the last visiting point

    up to 84 days

Study Arms (2)

paliperidone

EXPERIMENTAL

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

Drug: Paliperidone

placebo

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

PaliperidoneDRUG

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

Also known as: Paliperidone Extended-Release Tablets, Invega
paliperidone
placeboDRUG

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

placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Xiangya Hospital of Central University

Changsha, Hunan, 410011, China

Location

MeSH Terms

Interventions

Paliperidone Palmitate

Intervention Hierarchy (Ancestors)

IsoxazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • Wei Hao, MD., Ph.D.

    Central South University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
The Second Xiangya Hospital of Cental South University

Study Record Dates

First Submitted

March 28, 2013

First Posted

April 8, 2013

Study Start

February 1, 2013

Primary Completion

April 1, 2014

Study Completion

July 1, 2014

Last Updated

July 13, 2017

Record last verified: 2017-07

Locations

CN(1)