An Study of Aripiprazole in the Treatment of Methamphetamine Dependence

Methamphetamine Dependence Clinical Trial

Official title:

A Multiple-Center, Randomized, Double-Blind Study of Aripiprazole for Treatment of Methamphetamine Dependence

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01813656
• Other study ID #: 100000-068942
• Status: Terminated
• Phase: Phase 4
• First received: November 28, 2012
• Last updated: February 2, 2015
• Start date: September 2012
• Est. completion date: February 2014

Study information

• Verified date: February 2015
• Source: Central South University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics CommitteeChina: National Natural Science FoundationUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: February 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Patients,Diagnostic and Statistical Manual of Mental Disorders 4thed. (DSM-IV) criteria for Methamphetamine dependence.

2. Must sign a Information consent form.

3. Required to provide detailed address and phone number

Exclusion Criteria:

1. Serious organic disease.

2. Suicide ideation or hurt others.

3. Taking antipsychotic within two weeks before.

4. drug allergy to Risperidone or Aripiprazole.

5. pregnancy and breastfeeding women.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Methamphetamine Dependence

Intervention

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

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	methamphetamine-positive urine test results,self-reports of substance use	up to 3 months	Yes
Secondary	number of Participants with Adverse Events as a Measure of Safety and Tolerability	use Abnormal Involuntary Movement Scale ,Simpson-Angus Scale and Barnes akathisia Scale	up to 3 months	Yes