An Study of Aripiprazole in the Treatment of Methamphetamine Dependence

NCT01813656 | Terminated Phase 4 DMC

• 1 other identifier: 100000-068942
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Methamphetamine substance use is common worldwide. No approved pharmacologic treatments for methamphetamine dependence exist. Aripiprazole are Second generation antipsychotics，but have different pharmacological effects of neurotransmitters.To determine whether mirtazapine would reduce methamphetamine use among mehtamphetamine addicts.

Conditions

Methamphetamine Dependence

Keywords

Methamphetamine-Associated Psychosis; Aripiprazole

Outcome Measures

Primary Outcomes (1)

• abstinent time of Methamphetamine addict

  methamphetamine-positive urine test results,self-reports of substance use

  up to 3 months

Secondary Outcomes (1)

• number of Participants with Adverse Events as a Measure of Safety and Tolerability

  up to 3 months

Study Arms (2)

Aripiprazole

EXPERIMENTAL

Aripiprazole arm,5mg/pill,10mg/day.last12weeks.

Drug: Aripiprazole

Sugar pill

PLACEBO COMPARATOR

placebo arm,5mg/pill,10mg/day,last12weeks

Drug: placebo

Interventions

Aripiprazole DRUG

Aripiprazole group,5mg/pill,10mg/day non-forced titration method,last 12weeks

Also known as: Aopai H20041507

Aripiprazole

placebo DRUG

placebo group,5mg/pill,10mg/day non-forced titration method,last 12 weeks

Sugar pill

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients,Diagnostic and Statistical Manual of Mental Disorders 4thed. (DSM-IV) criteria for Methamphetamine dependence.
• Must sign a Information consent form.
• Required to provide detailed address and phone number

You may not qualify if:

• Serious organic disease.
• Suicide ideation or hurt others.
• Taking antipsychotic within two weeks before.
• drug allergy to Risperidone or Aripiprazole.
• pregnancy and breastfeeding women.

Sponsors & Collaborators

• Wei Hao: lead

Study Sites (1)

The Second Xiangya Hospital of Central University

Changsha, Hunan, 410011, China

Location

MeSH Terms

Interventions

Aripiprazole

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Wei Hao, MD., Ph.D.

  Central South University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• 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: November 28, 2012
• First Posted: March 19, 2013
• Study Start: September 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: February 1, 2014
• Last Updated: February 4, 2015

Record last verified: 2015-02

Locations

CN (1)