Aripiprazole for Methamphetamine Dependence: Double Blind Placebo Trial

June 25, 2015 updated by: US Department of Veterans Affairs

Double-blind Placebo Controlled Trial of Aripiprazole for Amphetamine

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
Assessed weekly for 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Reduction in methamphetamine craving as measured weekly by the Brief Substance Craving Scale (BSCS)
Time Frame: Assessed weekly for 12 weeks
Assessed weekly for 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
US Department of Veterans Affairs

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Syed Pirzada Sattar, MD, VA Medical Center, Omaha

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2009

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2010

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 31, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2008

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 26, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CDA-2-017-08S

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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