- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01813656
An Study of Aripiprazole in the Treatment of Methamphetamine Dependence
February 2, 2015 updated by: Wei Hao
A Multiple-Center, Randomized, Double-Blind Study of Aripiprazole for Treatment of Methamphetamine Dependence
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
Methods:A Multiple-Center, Randomized, Double-Blind.
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hunan
-
Changsha, Hunan, China, 410011
- The Second XiangYa Hospital Of Central University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Aripiprazole
Aripiprazole arm,5mg/pill,10mg/day.last12weeks.
|
Aripiprazole group,5mg/pill,10mg/day non-forced titration method,last 12weeks
Other Names:
|
PLACEBO_COMPARATOR: Sugar pill
placebo arm,5mg/pill,10mg/day,last12weeks
|
placebo group,5mg/pill,10mg/day non-forced titration method,last 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
abstinent time of Methamphetamine addict
Time Frame: up to 3 months
|
methamphetamine-positive urine test results,self-reports of substance use
|
up to 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: up to 3 months
|
use Abnormal Involuntary Movement Scale ,Simpson-Angus Scale and Barnes akathisia Scale
|
up to 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2012
Primary Completion (ACTUAL)
December 1, 2013
Study Completion (ACTUAL)
February 1, 2014
Study Registration Dates
First Submitted
November 28, 2012
First Submitted That Met QC Criteria
March 15, 2013
First Posted (ESTIMATE)
March 19, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
February 4, 2015
Last Update Submitted That Met QC Criteria
February 2, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
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
- Antidepressive Agents
- Dopamine Agonists
- Dopamine Agents
- Serotonin 5-HT1 Receptor Agonists
- Serotonin Receptor Agonists
- Serotonin 5-HT2 Receptor Antagonists
- Serotonin Antagonists
- Dopamine D2 Receptor Antagonists
- Dopamine Antagonists
- Aripiprazole
Other Study ID Numbers
- 100000-068942
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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