Methamphetamine Dependence Clinical Trial
Official title:
Double-blind Placebo Controlled Trial of Aripiprazole for Amphetamine
Verified date | June 2015 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | April 2010 |
Est. primary completion date | April 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 19 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction in methamphetamine use as measured weekly by the Time Line Follow Back (TLFB) and Urine Drug Screens | Assessed weekly for 12 weeks | No | |
Secondary | Reduction in methamphetamine craving as measured weekly by the Brief Substance Craving Scale (BSCS) | Assessed weekly for 12 weeks | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT01813656 -
An Study of Aripiprazole in the Treatment of Methamphetamine Dependence
|
Phase 4 | |
Completed |
NCT00984360 -
Study of Naltrexone for Methamphetamine Addiction
|
Phase 2 | |
Completed |
NCT01685463 -
Transcranial Magnetic Stimulation Used to Both Measure Cortical Excitability and Explore Methamphetamine Cue Craving
|
N/A | |
Completed |
NCT00569374 -
Safety and Tolerability of Modafinil for Methamphetamine Dependence
|
Phase 2 | |
Completed |
NCT01967381 -
Targeting GABA and Opioid Systems for a Pharmacotherapy for Methamphetamine Abuse
|
Early Phase 1 | |
Completed |
NCT01354470 -
A Randomized, Placebo-Controlled Trial of Modafinil for Methamphetamine Dependence
|
Phase 2 | |
Active, not recruiting |
NCT01044238 -
Methylphenidate to Treat Methamphetamine Dependence
|
Phase 2 | |
Completed |
NCT01215929 -
Studying Amphetamine Withdrawal in Humans
|
Phase 2 | |
Terminated |
NCT01019707 -
Safety Assessment of Atomoxetine With MA IV Administration
|
Phase 1 | |
Completed |
NCT00227123 -
A Randomized Control Trial Comparing Quetiapine to Risperidone in Bipolar Disorder With Stimulant Dependence
|
N/A | |
Recruiting |
NCT02568878 -
Creatine for Depressed Male and Female Methamphetamine Users
|
Phase 3 | |
Completed |
NCT01007539 -
Efficacy and Safety of CDP-choline in Patients With Methamphetamine Dependence
|
Phase 3 | |
Completed |
NCT01011829 -
Varenicline vs Placebo for the Treatment of Methamphetamine Dependence
|
Phase 2 | |
Completed |
NCT01062451 -
An ACE Inhibitor (Perindopril) or an Angiotensin Receptor Blocker (Candesartan) as a Treatment for Methamphetamine Dependence
|
Phase 1 | |
Completed |
NCT00687713 -
Phase 2, Double-Blind, Placebo-Controlled Trial of Bupropion for Methamphetamine Dependence
|
Phase 2 | |
Completed |
NCT01063205 -
NAC as a Potential Treatment for Methamphetamine Dependence
|
Phase 1 | |
Completed |
NCT02058966 -
Pilot Study of Entacapone for Methamphetamine Abuse
|
Early Phase 1 | |
Completed |
NCT00332605 -
N-Acetyl Cysteine Plus Naltrexone in Methamphetamine Dependence
|
Phase 2 | |
Completed |
NCT01860807 -
Trial of Ibudilast for Methamphetamine Dependence
|
Phase 2 | |
Terminated |
NCT01813643 -
A Comparison of Risperidone and Aripiprazole for Treatment of Patirnts With Methamphetamine-Associated Psychosis
|
Phase 4 |