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The primary purpose of this study is to determine how efficacy of quetiapine (seroquel XR) in improving the sleep in recovering alcohol dependent subjects.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Quetiapine XR |
|
| 2 | Placebo Comparator | Placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quetiapine XR | Drug | Quetiapine is a second generation antipsychotic medication, which has also recently shown to be associated with properties of mood stabilization in bipolar disorder. |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Efficiency (From an In-laboratory Polysomnogram) | The fraction of time spent asleep to the total time in bed (%). | Baseline, and week 8 of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia Severity Index (ISI) | ISI total score; this scale assesses for global insomnia severity (range 0-24). Higher scale scores indicate higher insomnia severity. | Baseline, weeks 1, 3, 5, and 7 of treatment. |
| Pittsburgh Sleep Quality Index (PSQI) |
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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.](streamdown:incomplete-link)
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| Name | Affiliation | Role |
|---|---|---|
| Subhajit Chakravorty, MD | Philadelphia, OPC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Philadelphia, OPC | Philadelphia | Pennsylvania | 19106 | United States |
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Addiction psychiatry clinic, behavioral health laboratory, and self referrals solicited through flyers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Quetiapine XR | The pills were taken at bedtime and the dose was titrated flexibly in the following fashion over the first week: 50 mg dose for 2 nights, followed by 200 mg a night for 2 nights, and then 300 mg a night for 2 nights and to a final dose of 400 mg daily starting on night # 7. Medication taper commenced at week 8 in the reverse stepwise fashion after the second set of two polysomnograms. |
| FG001 | Placebo | The matching placebo pills were similarly taken at bedtime and the dose was titrated flexibly in the following fashion over the first week: 50 mg dose for 2 nights, followed by 200 mg a night for 2 nights, and then 300 mg a night for 2 nights and to a final dose of 400 mg daily starting on night # 7. Medication taper commenced at week 8 in the reverse stepwise fashion after the second set of two polysomnograms. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Quetiapine | Quetiapine XR |
| BG001 | Placebo | Placebo |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sleep Efficiency (From an In-laboratory Polysomnogram) | The fraction of time spent asleep to the total time in bed (%). | Posted | Mean | Standard Deviation | percentage | Baseline, and week 8 of treatment. |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Quetiapine | Quetiapine XR |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal ideation | Psychiatric disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Somnolence | Psychiatric disorders | Systematic Assessment |
The limitations of this study include the small sample size, and assessment of PSQI, PHQ-9, BAI, and SF-12 at week 9 (immediately after washout from the study drug). The corruption of stored online actigraphic sleep data prevented its interpretation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Subhajit Chakravorty | Philadelphia VAMC | 215-823-5800 | 3405 | Subhajit.Chakravorty@va.gov |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| Placebo. | Drug | Inactive or inert pill which will be used as a comparator. |
|
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.
| Baseline, weeks 4, and 9. |
| Wake After Sleep Onset Time (WASO) From an In-laboratory Polysomnogram. | 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). | Baseline, and week 8 |
| Total |
Total of all reporting groups |
| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Insomnia Severity Index (ISI) | ISI total score; this scale assesses for global insomnia severity (range 0-24). Higher scale scores indicate higher insomnia severity. | Posted | Mean | Standard Deviation | units on a scale | Baseline, weeks 1, 3, 5, and 7 of treatment. |
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|
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| Secondary | Pittsburgh Sleep Quality Index (PSQI) | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, weeks 4, and 9. |
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| Secondary | Wake After Sleep Onset Time (WASO) From an In-laboratory Polysomnogram. | 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). | Posted | Mean | Standard Deviation | minutes | Baseline, and week 8 |
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| 2 |
| 10 |
| 7 |
| 10 |
| EG001 | Placebo | Placebo | 2 | 10 | 3 | 10 |
| Relapse to heavy alcohol use leading to inpatient admission | Psychiatric disorders | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Insomnia | Psychiatric disorders | Systematic Assessment |
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| Increased apetite | Psychiatric disorders | Systematic Assessment |
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| Dizziness | Cardiac disorders | Systematic Assessment |
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| Somatic pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Agitation | Psychiatric disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Decreased motivation | Psychiatric disorders | Systematic Assessment |
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| Headache | Nervous system disorders |
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| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| PSQI (week 9) |
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