An Study of Aripiprazole in the Treatment of Methamphetam... | NCT01813656

Studies
An Study of Aripiprazole in the Treatment of Methamphetamine Dependence

NCT01813656

Sponsor

Wei Hao

Status

Terminated

Last Update Posted

Feb 4, 2015Estimated

Enrollment

10Actual

Phase

Phase 4

Conditions

Methamphetamine Dependence

Interventions

Aripiprazole
placebo

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Aripiprazole arm had obvious adverse reactions,especially akathisia.

Expanded Access Info

Start Date

Sep 2012

Primary Completion Date

Dec 2013Actual

Completion Date

Feb 2014Actual

First Submitted Date

Nov 28, 2012

First Submission Date that Met QC Criteria

Mar 15, 2013

First Posted Date

Mar 19, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 2, 2015

Last Update Posted Date

Feb 4, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Aripiprazole	Drug	Aripiprazole group,5mg/pill,10mg/day non-forced titration method,last 12weeks	Aripiprazole

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
abstinent time of Methamphetamine addict	methamphetamine-positive urine test results,self-reports of substance use	up to 3 months

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wei Hao, MD., Ph.D.	Central South University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Second Xiangya Hospital of Central University		Changsha	Hunan	410011	China

Intervention Browse Module

MeSH Terms

ID	Term
D000068180	Aripiprazole

Ancestor Terms

ID	Term
D010879	Piperazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D015363	Quinolones

Browse Leaves

Not provided

Browse Branches

Not provided