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
|Condition or disease||Intervention/treatment||Phase|
|Alcoholism Sleep Initiation and Maintenance Disorders||Drug: Quetiapine XR Drug: Placebo.||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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
Inactive or inert pill which will be used as a comparator.
- 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 (%).
- 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.
- 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.
- 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).
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
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19106|
|Principal Investigator:||Subhajit Chakravorty, MD||Philadelphia, OPC|