Status:
COMPLETED
The Effects of Quetiapine (Seroquel XR) on Sleep During Alcohol Abstinence
Lead Sponsor:
Subhajit Chakravorty
Conditions:
Alcoholism
Sleep Initiation and Maintenance Disorders
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The primary purpose of this study is to determine how efficacy of quetiapine (seroquel XR) in improving the sleep in recovering alcohol dependent subjects.
Detailed Description
Sober alcohol dependent subjects frequently complain of difficulty falling asleep as well as staying asleep which may eventually lead to relapse. Novel antipsychotic medications such as quetiapine hav...
Eligibility Criteria
Inclusion
- subjects between the ages of 18-65 years, with a DSM-IV diagnosis of current alcohol dependence (past year), can speak, understand, and print in English, and is capable of giving written informed consent
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00434876
Start Date
August 1 2007
End Date
December 1 2009
Last Update
August 9 2013
Active Locations (1)
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1
Philadelphia, OPC
Philadelphia, Pennsylvania, United States, 19106