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Aripiprazole for Methamphetamine Dependence: Double Blind Placebo Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00728312
Recruitment Status : Withdrawn (PI left the VA.)
First Posted : August 5, 2008
Last Update Posted : June 26, 2015
Information provided by:
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Methamphetamine Dependence Drug: Aripiprazole Drug: Placebo Phase 4

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 participant's 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. Patient's 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Double-blind Placebo Controlled Trial of Aripiprazole for Amphetamine
Study Start Date : August 2009
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Methamphetamine

Arm Intervention/treatment
Active Comparator: 1
Aripiprazole (Abilify), flexible dosing 5-15 mg per day
Drug: Aripiprazole
12 week comparison of active medication (aripiprazole 5-15 mg per day) versus Placebo (placebo look-alike 5-15 mg per day)
Other Name: Abilify

Placebo Comparator: 2
Placebo look-alike, flexible dosing 5-15 mg per day
Drug: Placebo
12 week comparison of placebo 5-15 mg per day (pill which contains no active medication) versus active medication (aripiprazole 5-15 mg per day)

Primary Outcome Measures :
  1. Reduction in methamphetamine use as measured weekly by the Time Line Follow Back (TLFB) and Urine Drug Screens [ Time Frame: Assessed weekly for 12 weeks ]

Secondary Outcome Measures :
  1. Reduction in methamphetamine craving as measured weekly by the Brief Substance Craving Scale (BSCS) [ Time Frame: Assessed weekly for 12 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00728312

Sponsors and Collaborators
US Department of Veterans Affairs
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Principal Investigator: Syed Pirzada Sattar, MD VA Medical Center, Omaha

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Responsible Party: Sattar, Syed - Principal Investigator, Department of Veterans Affairs Identifier: NCT00728312    
Other Study ID Numbers: CDA-2-017-08S
First Posted: August 5, 2008    Key Record Dates
Last Update Posted: June 26, 2015
Last Verified: June 2015
Keywords provided by VA Office of Research and Development:
Additional relevant MeSH terms:
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Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Central Nervous System Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors