Ignite Creation Date:
2024-05-05 @ 7:44 PM
Last Modification Date:
2024-10-26 @ 9:53 AM
Study NCT ID:
NCT00728312
Status:
WITHDRAWN
Last Update Posted:
2015-06-26
First Post:
2008-07-31
Brief Title:
Aripiprazole for Methamphetamine Dependence Double Blind Placebo Trial
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Double-blind Placebo Controlled Trial of Aripiprazole for Amphetamine
Status:
WITHDRAWN
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI left the VA
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to test whether treatment with Aripiprazole leads to a reduction in methamphetamine craving and use in patients diagnosed with methamphetamine dependence Patients presenting at the Omaha VA Medical Center for treatment of methamphetamine dependence and meet inclusion criteria for the study will be invited to participate Participation in the study will last for approximately 14 weeks
Detailed Description:
Methamphetamine abuse and dependence have become a major health problem The lifetime prevalence rates for these disorders may be as high as 2-3 and can lead to significant medical psychiatric and dental problems and can increase morbidity and mortality Methamphetamine abuse is a pattern of use that leads to problems in one or more areas of life Methamphetamine dependence is a more severe disorder often involving biological adaptations to the effects of methamphetamine such as tolerance to or physical dependence on methamphetamine loss of control over its use as noted by several failed attempts at quitting preoccupation with the next high etc and maladaptive consequences secondary to its excessive use including the medical legal and social consequences of methamphetamine intake The lack of any FDA-approved medications for methamphetamine dependence has resulted in an increased demand for research in the area of pharmacotherapy of this disorder While some medications have been studied in an exploratory fashion there is still a great need for more research in this area The purpose of this study is to examine the efficacy of aripiprazole at a relatively low dose of 5-15 mg per day as compared to placebo in a prospective double blinded study in participants with methamphetamine dependence in reducing the use and craving for methamphetamine We expect that aripiprazole will significantly reduce the use of methamphetamine as measured by the changed in the proportion of participants methamphetamine-free weeks Secondary outcomes include urine for quantitative methamphetamine self-report of methamphetamine use as measured by the Time Line Follow Back Scale - TLFB and Brief Substance Craving Scale -BSCS caving and use of other substances over the course of the 12 week active treatment portion of the trial A secondary goal of this study will be to test the efficacy of the Interactive Voice Response IVR technology to gather data from participants and its correlation with the data on methamphetamine and other substance use craving and medication adherence collected during the weekly visits Patients mood and anxiety will be measured through the course of the study using the Hamilton Anxiety Scale HAM-A Hamilton Depression Scale HAM-D and Quality of Life Index QOLI Safety measures will include the Abnormal Involuntary Movement Scale AIMS Side Effects Checklist SEC Barnes Akathisia scale Fasting Blood Glucose Monitoring and patient weight monitoring
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None