Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
46 participants
INTERVENTIONAL
2013-08-27
2018-11-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Study Groups
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acamprosate
The maximum dose of acamprosate to be used in this study is 666 mg three times daily (total 1998 mg/day) for subjects weight ≥ 50 kg and 1332mg for subjects that weigh \< 50 kg.
acamprosate
Placebo
Placebo will be prescribed with the same frequency and duration as the acamprosate group.
Placebo
Interventions
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acamprosate
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age ≥5 years and \<23 years
* General good health as determined by physical exam, medical history and laboratory work up.
Exclusion Criteria
* Unstable dosing of any psychotropic medication (medication affecting behavior)
* Problems with kidney functioning
* Unstable seizure disorder
* Change in any anti-convulsant drug dosing in the 60 days prior to study entry
* Prior adequate treatment trial with acamprosate as determined by the study doctor
* Pregnant or lactating females
5 Years
23 Years
ALL
Yes
Sponsors
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Rush University Medical Center
OTHER
Children's Hospital Medical Center, Cincinnati
OTHER
Responsible Party
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Principal Investigators
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Craig Erickson, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Elizabeth Berry-Kravis, MD
Role: PRINCIPAL_INVESTIGATOR
Rush University Medical Center
Locations
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Rush University Medical Center
Chicago, Illinois, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Countries
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Other Identifiers
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CIN001- Acamprosate in FX
Identifier Type: -
Identifier Source: org_study_id
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