Methamphetamine DependencePhase 4NCT00728312
Aripiprazole for Methamphetamine Dependence: Double Blind Placebo Trial
A Phase 4 study testing Aripiprazole in people with Methamphetamine Dependence, run by US Department of Veterans Affairs.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Methamphetamine Dependence
- What is being tested?
- Aripiprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2009to Apr 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Methamphetamine Dependence
- Being tested
- Aripiprazole, Placebo
- Keywords
- Methamphetamine, Therapeutics, Psychopharmacology, Amphetamine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AripiprazoleDrug
Also called Abilify
12 week comparison of active medication (aripiprazole 5-15 mg per day) versus Placebo (placebo look-alike 5-15 mg per day)
PlaceboDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Aripiprazole (Abilify), flexible dosing 5-15 mg per day Receives: Drug: Aripiprazole |
| 2 | Placebo comparator | Placebo look-alike, flexible dosing 5-15 mg per day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in methamphetamine use as measured weekly by the Time Line Follow Back (TLFB) and Urine Drug Screens
Measured: Assessed weekly for 12 weeks
Secondary outcomes (1)
Reduction in methamphetamine craving as measured weekly by the Brief Substance Craving Scale (BSCS)
Measured: Assessed weekly for 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2008 (estimated)
- Study startAug 2009
- Primary completionApr 2010
- Study completionApr 2010
Why it stopped: PI left the VA.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methamphetamine DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Investigators
- Syed Pirzada Sattar, MD, Principal investigator, VA Medical Center, Omaha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00728312
- Sponsor's protocol ID
- CDA-2-017-08S
- Status last verified
- Jun 2015
- First submitted
- 31 Jul 2008
- Last updated
- 26 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind Placebo Controlled Trial of Aripiprazole for Amphetamine
- ClinicalTrials.gov ID
- NCT00728312
- Acronym / sponsor ID
- CDA-2-017-08S
- Conditions
- Methamphetamine Dependence
- Keywords
- Methamphetamine, Therapeutics, Psychopharmacology, Amphetamine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left the VA.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Aug 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 5 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: AripiprazoleAripiprazole (Abilify), flexible dosing 5-15 mg per day |
| 2 | Placebo comparator | Drug: PlaceboPlacebo look-alike, flexible dosing 5-15 mg per day |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AripiprazoleAlso: Abilify12 week comparison of active medication (aripiprazole 5-15 mg per day) versus Placebo (placebo look-alike 5-15 mg per day) | Drug | 1 |
| Placebo12 week comparison of placebo 5-15 mg per day (pill which contains no active medication) versus active medication (aripiprazole 5-15 mg per day) | Drug | 2 |
Primary outcome
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
1 secondary outcome
Reduction in methamphetamine craving as measured weekly by the Brief Substance Craving Scale (BSCS)
Time frame: Assessed weekly for 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Syed Pirzada Sattar, MD principal investigator
VA Medical Center, Omaha
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aripiprazole in people with Methamphetamine Dependence, run by US Department of Veterans Affairs.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2015.