|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00728312 |
|
Date of registration:
|
31/07/2008 |
|
Primary sponsor: |
|
|
Public title:
|
Aripiprazole for Methamphetamine Dependence: Double Blind Placebo Trial
|
|
Scientific title:
|
Double-blind Placebo Controlled Trial of Aripiprazole for Amphetamine |
|
Date of first enrolment:
|
August 2009 |
|
Target sample size:
|
50 |
|
Recruitment status: |
Withdrawn |
|
URL:
|
http://clinicaltrials.gov/show/NCT00728312 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Syed Pirzada Sattar, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
VA Medical Center, Omaha |
| | |
|
Key inclusion & exclusion criteria
|
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
Age minimum:
19 Years
Age maximum:
65 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Methamphetamine Dependence
|
|
Intervention(s)
|
|
Drug: Aripiprazole
|
|
Drug: Placebo
|
|
Primary Outcome(s)
|
|
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(s)
|
|
Reduction in methamphetamine craving as measured weekly by the Brief Substance Craving Scale (BSCS)
[Time Frame: Assessed weekly for 12 weeks]
|
|
Secondary ID(s)
|
|
CDA-2-017-08S
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|