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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00859573 |
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Date of registration:
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10/03/2009 |
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Primary sponsor: |
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Public title:
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Modafinil for Methamphetamine Dependence
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Scientific title:
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Clinical Efficacy of Modafinil in Recently-Abstinent Methamphetamine-Dependent Volunteers |
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Date of first enrolment:
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April 2009 |
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Target sample size:
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9 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00859573 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Michael Mancino, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Arkansas |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
18-65 years old. For the neurophysiological measures portion of the study subjects will
be included if they are between the ages of 20-65 because the P50 potential is not fully
developed in children and adolescents (Rasco 2000).
- not currently enrolled in a treatment program
- subjects must have a history of methamphetamine use with recent use confirmed by a
positive urine toxicology screen for amphetamines during the month prior to study
entry
- subjects must meet DSM-IV criteria for amphetamine dependence as assessed by the
substance abuse section of the Structured Clinical Interview for DSM-IV (SCID)
- women of childbearing age must have a negative pregnancy test to enroll in this
study, agree to monthly pregnancy testing, and agree to use appropriate forms of
birth control for the duration of the study.
Exclusion Criteria:
- current diagnosis of alcohol, opiate, or sedative physical dependence
- ill health (e.g., major cardiovascular, renal, endocrine, hepatic disorder)
- history of schizophrenia, or bipolar type I disorder
- present or recent use of over-the-counter or prescription psychoactive drug or
drug(s) that would be expected to have major interaction with drug to be tested
- medical contraindication to receiving study medications (e.g., allergy to modafinil,
treatment with cyclosporine, clomipramine or desipramine)
- current suicidality or psychosis
- Liver function tests (i.e., liver enzymes) greater than three times normal levels
- pregnancy or breastfeeding
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Methamphetamine Dependence
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Intervention(s)
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Drug: Modafinil
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Drug: Placebo
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Primary Outcome(s)
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Mean Treatment Effectiveness Scores
[Time Frame: thrice weekly from week 3 through week 8]
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Withdrawal Symptoms
[Time Frame: thrice weekly]
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Secondary Outcome(s)
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Attentional Neurophysiological Measures
[Time Frame: week 0, 2, 10]
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Pre-attentional Neurophysiological Measures
[Time Frame: week 0, week 2, week 10]
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Vital Signs
[Time Frame: thrice weekly]
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Secondary ID(s)
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DPMCDA
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P50 DA018197
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P50 DA018197-104386
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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