The Effects of Quetiapine (Seroquel XR) on Sleep During Alcohol Abstinence
NCT ID: NCT00434876
Last Updated: 2013-08-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
22 participants
INTERVENTIONAL
2007-08-31
2009-12-31
Brief Summary
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Detailed Description
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The primary aim of this study is to determine the degree to which quetiapine improves sleep in veterans during the early phase of recovery from alcohol dependence. The sleep efficiency from an in-lab polysomnogram will be the primary outcome measure. Secondary measures of sleep will include the Pittsburgh Sleep Quality Index, Insomnia Severity Index, and actigraphy. Other additional aims will explore for alcohol use and cravings, change in psychiatric symptoms using the The Time Line Follow Back measure, Penn Alcohol Craving Scale (PACS), the Patient Health Questionnaire-9 item scale (PHQ-9), and the Beck's Anxiety Inventory (BAI) respectively.
Twenty four subjects within the first year of sobriety will be enrolled. Participants will be undergo an extensive baseline screening procedure. After 2 consecutive in-laboratory polysomnograms they will be treated with either Quetiapine XR or matching placebo pills targetting a dose of 400 mg a night. The treatment duration will be 8 weeks and during the eight week of treatment they will undergo 2 more nights of in-laboratory polysomnogram. All subjects will also receive Medical Management therapy, a standardized psychosocial intervention which is medically-based and focusses on alcohol abstinence and medication compliance.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Quetiapine XR
Quetiapine XR
Quetiapine is a second generation antipsychotic medication, which has also recently shown to be associated with properties of mood stabilization in bipolar disorder.
2
Placebo
Placebo.
Inactive or inert pill which will be used as a comparator.
Interventions
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Quetiapine XR
Quetiapine is a second generation antipsychotic medication, which has also recently shown to be associated with properties of mood stabilization in bipolar disorder.
Placebo.
Inactive or inert pill which will be used as a comparator.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria: Positive urine drug screen for opioids, cocaine, or amphetamine (excluding THC), dependence on other drugs excluding alcohol/nicotine/cannabis over the past year, unstable psychiatric, medical disorders, cataracts \[posterior capsular/ nuclear (grade NS3 or more), currently on any maintenance psychotropic medications affecting sleep, currently pregnant, nursing, or not using a reliable method of contraception; history of hypersensitivity to antipsychotic drugs, including quetiapine, severe cognitive impairment, severe untreated obstructive sleep apnea, and inadequately controlled diabetes mellitus.
18 Years
65 Years
ALL
No
Sponsors
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Subhajit Chakravorty
FED
Responsible Party
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Subhajit Chakravorty
Staff Physician
Principal Investigators
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Subhajit Chakravorty, MD
Role: PRINCIPAL_INVESTIGATOR
Philadelphia, OPC
Locations
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Philadelphia, OPC
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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101206
Identifier Type: -
Identifier Source: org_study_id