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The Effects of Quetiapine (Seroquel XR) on Sleep During Alcohol Abstinence

Information source: Philadelphia Veterans Affairs Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alcoholism; Sleep Initiation and Maintenance Disorders

Intervention: Quetiapine XR (Drug); Placebo. (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Subhajit Chakravorty

Official(s) and/or principal investigator(s):
Subhajit Chakravorty, MD, Principal Investigator, Affiliation: Philadelphia, OPC

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.

Clinical Details

Official title: The Effects of Quetiapine on Sleep During Alcohol Abstinence

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Sleep Efficiency (From an In-laboratory Polysomnogram)

Secondary outcome:

Insomnia Severity Index (ISI)

Pittsburgh Sleep Quality Index (PSQI)

Wake After Sleep Onset Time (WASO) From an In-laboratory Polysomnogram.

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 have shown some efficacy in treating alcoholism and have also shown some benefit in improving insomnia. 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.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 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 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.

Locations and Contacts

Philadelphia, OPC, Philadelphia, Pennsylvania 19106, United States
Additional Information

Starting date: August 2007
Last updated: July 9, 2013

Page last updated: August 23, 2015

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