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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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13 May 2013 |
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Main ID: |
NCT01215929 |
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Date of registration:
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01/10/2010 |
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Primary sponsor: |
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Public title:
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Studying Amphetamine Withdrawal in Humans
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Scientific title:
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Amphetamine Withdrawal Paradigm in Humans |
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Date of first enrolment:
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October 2009 |
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Target sample size:
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16 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01215929 |
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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: 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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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 21-65 years old
- not currently enrolled in a treatment program
- history of methamphetamine use with recent use confirmed by a positive urine
toxicology screen for amphetamines during the month prior to study entry
- self-reported Methamphetamine use on at least 15 of the past 30 days
- use of at least one half gram of methamphetamine per week during the month prior to
study entry
- women of childbearing age must have a negative pregnancy test to enroll in this 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 d-amphetamine
- medical contraindication to receiving study medications (e.g., previous adverse
reaction to d-amphetamine)
- chronic pain condition (due to impact on neurophysiological responses
- current suicidality or psychosis
- liver function tests (i.e., liver enzymes) greater than three times normal levels
- pregnancy or breastfeeding
- children 18-20 will be excluded because the P50 potential is not fully developed in
children and adolescents
Age minimum:
21 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: Dextroamphetamine
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Drug: Placebo
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Primary Outcome(s)
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Measure of methamphetamine withdrawal
[Time Frame: at the end of week 4]
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Measure of methamphetamine withdrawal
[Time Frame: end of week 1]
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Measure of methamphetamine withdrawal
[Time Frame: end of week 2]
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Measure of methamphetamine withdrawal
[Time Frame: end of week 3]
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Secondary Outcome(s)
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Retention in treatment
[Time Frame: at the end of week 4]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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