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Trial record 60 of 450 for:    QUETIAPINE

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

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ClinicalTrials.gov Identifier: NCT00434876
Recruitment Status : Completed
First Posted : February 14, 2007
Results First Posted : August 9, 2013
Last Update Posted : August 9, 2013
Sponsor:
Information provided by (Responsible Party):
Subhajit Chakravorty, Corporal Michael J. Crescenz VA Medical Center

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.

Condition or disease Intervention/treatment Phase
Alcoholism Sleep Initiation and Maintenance Disorders Drug: Quetiapine XR Drug: Placebo. Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Quetiapine on Sleep During Alcohol Abstinence
Study Start Date : August 2007
Actual Primary Completion Date : November 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
Quetiapine XR
Drug: 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.
Other Name: Seroquel XR

Placebo Comparator: 2
Placebo
Drug: Placebo.
Inactive or inert pill which will be used as a comparator.




Primary Outcome Measures :
  1. Sleep Efficiency (From an In-laboratory Polysomnogram) [ Time Frame: Baseline, and week 8 of treatment. ]
    The fraction of time spent asleep to the total time in bed (%).


Secondary Outcome Measures :
  1. Insomnia Severity Index (ISI) [ Time Frame: Baseline, weeks 1, 3, 5, and 7 of treatment. ]
    ISI total score; this scale assesses for global insomnia severity (range 0-24). Higher scale scores indicate higher insomnia severity.

  2. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Baseline, weeks 4, and 9. ]

    PSQI total score (range 0-21). A PSQI total score > 5 indicates insomnia, with higher scores denoting a decrease in sleep quality.

    The PSQI global score assesses for the overall quality of sleep and is computed by adding the 7 component scale scores. This widely used 19-item self-rated scale evaluates the subjective quality of sleep over the last 4 weeks. The PSQI was administered at baseline, and weeks 4, and 9.


  3. Wake After Sleep Onset Time (WASO) From an In-laboratory Polysomnogram. [ Time Frame: Baseline, and week 8 ]
    The amount of time spent awake after initially falling asleep and before final awakening (in minutes). None to a fewer minutes is better (than a higher number of minutes).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00434876


Locations
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United States, Pennsylvania
Philadelphia, OPC
Philadelphia, Pennsylvania, United States, 19106
Sponsors and Collaborators
Subhajit Chakravorty
Investigators
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Principal Investigator: Subhajit Chakravorty, MD Philadelphia, OPC

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Responsible Party: Subhajit Chakravorty, Staff Physician, Corporal Michael J. Crescenz VA Medical Center
ClinicalTrials.gov Identifier: NCT00434876     History of Changes
Other Study ID Numbers: 101206
First Posted: February 14, 2007    Key Record Dates
Results First Posted: August 9, 2013
Last Update Posted: August 9, 2013
Last Verified: July 2013
Keywords provided by Subhajit Chakravorty, Corporal Michael J. Crescenz VA Medical Center:
Alcoholism
Insomnia
Quetiapine
Seroquel
Additional relevant MeSH terms:
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Quetiapine Fumarate
Sleep Initiation and Maintenance Disorders
Alcoholism
Alcohol Abstinence
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Drinking Behavior
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs