Status:
WITHDRAWN
Aripiprazole for Methamphetamine Dependence: Double Blind Placebo Trial
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
Methamphetamine Dependence
Eligibility:
All Genders
19-65 years
Phase:
PHASE4
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 present...
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 ...
Eligibility Criteria
Inclusion
- Veterans, ages 19 to 65, willing and able to provide informed consent
- Primary diagnosis of methamphetamine dependence as determined by the Structured Clinical Interview for the DSM-IV (SCID-II). They must not have current dependence with other substances such as alcohol, cocaine, opiates, and marijuana. However, abuse of these drugs will be allowed for this study.
- Within 30 days of last use of methamphetamine.
- Must have been using at least once a month for the past three months at enrollment.
- Present without any current intoxication effects of methamphetamine to provide informed consent at the time of the baseline session
- No diagnosis of schizophrenia by the SCID. If they have a history of a mood or anxiety disorder, they will not be in active pharmacological treatment for at least the previous two weeks
- Must not be suicidal or homicidal
- Not currently taking psychotropics (antipsychotic, mood stabilizing, anti-anxiety, or antidepressant medications)
- Female subjects must not be pregnant or lactating, and must be using approved birth control methods if of child bearing potential
- No medical contraindications (such as recent myocardial infarctions, cerebrovascular accidents, or abnormal lab values above 3 x normal ranges)
- No unstable diabetes or current fasting blood glucose test \>140 mg/dl
- No diagnosis of dementia
- Must have stable address and access to a telephone
Exclusion
- Inability or unwillingness to provide consent
- Medical or psychiatric instability, requiring inpatient treatment
- Previous reported allergic or adverse reaction to aripiprazole
- Being under an involuntary commitment for in/outpatient psychiatric treatment
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00728312
Start Date
August 1 2009
End Date
April 1 2010
Last Update
June 26 2015
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