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The Effects of Quetiapine (Seroquel XR) on Sleep During Alcohol Abstinence
This study is currently recruiting participants.
Verified by Department of Veterans Affairs, February 2009
First Received: February 12, 2007   Last Updated: February 6, 2009   History of Changes
Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00434876
  Purpose

The purpose of this study to determine how effective quetiapine (seroquel XR) is in improving the sleep and also maintaining sobriety in recovering alcohol dependent veteran subjects.


Condition Intervention Phase
Alcoholism
Sleep Initiation and Maintenance Disorders
Drug: Quetiapine XR
Drug: Placebo.
Phase III

MedlinePlus related topics: Alcoholism
Drug Information available for: Quetiapine Quetiapine fumarate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: The Effects of Quetiapine on Sleep During Alcohol Abstinence

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Sleep Efficiency (from an in-laboratory polysomnogram) [ Time Frame: 8 weeks. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective sleep-wake recordings using actigraphy. [ Time Frame: 8 weeks. ] [ Designated as safety issue: No ]
  • Pittsburgh Sleep Quality Index, Insomnia Severity Index and Epworth Sleepiness Scale. [ Time Frame: 8 weeks. ] [ Designated as safety issue: No ]
  • Time Line Followback, Penn Alcohol craving scale. [ Time Frame: 8 weeks. ] [ Designated as safety issue: No ]
  • PHQ-9, Beck's Anxiety Rating Scale [ Time Frame: 8 weeks. ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: August 2007
Estimated Study Completion Date: November 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
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.
2: Placebo Comparator
Placebo
Drug: Placebo.
Inactive or inert pill which will be used as a comparator.

Detailed Description:

Sober alcoholics frequently complain of difficulty falling asleep as well as staying asleep which may eventually lead to relapse. Previous research reports a relationship between sleep problems and alcoholism, with ten percent of all alcoholism-related costs attributable to insomnia and its consequences. Novel antipsychotic medications such as quetiapine have been investigated for efficacy in treating alcoholism. A recent pilot study of quetiapine, conducted at the affiliated University of Pennsylvania Medical Center, demonstrated its efficacy in promoting sleep and reducing alcohol use among alcohol dependent subjects.

The primary aim of this study is to determine the degree to which quetiapine improves insomnia 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, to assess the overall improvement in sleep.

Secondary measures of sleep will include the objective sleep-wake recordings using actigraphy, Pittsburgh Sleep Quality Index, Insomnia Severity Index (to assess insomnia characteristics), Epworth Sleepiness Scale (to assess daytime sleepiness). A secondary aim is to assess the relationship between insomnia severity and alcohol use. The Time Line Follow Back measure will be the outcome measure to assess alcohol use between visits. Another additional aim will be to assess the relationship between change in the anxiety and depressive symptoms and an improvement in the sleep on the quetiapine. The PHQ-9, Hamilton Anxiety Rating Scale, Timeline Follow Back measure, sleep efficiency (from an in-laboratory polysomnogram), the objective sleep-wake recordings using the actigraph and the Pittsburgh Sleep Quality Index,will be used as the outcome measures.

To meet the aims of this study, 24 subjects will be enrolled. After achieving at least 3 days of abstinence, participants will be undergo baseline screening for psychiatric, medical and sleep disorders as well as drug use disorders, including a portable home sleep study. Subsequently the subjects will stay for two consecutive nights in sleep laboratory. After the first set of sleep studies, subjects will be randomly assigned to receive either placebo or quetiapine. The subjects will then be followed weekly using the Medical Management paradigm (similar to the one used in the NIAAA COMBINE study). Medical Management is a standardized psychosocial intervention which is medically based and focused on alcohol abstinence and medication compliance and conducted by a qualified nurse or the principal investigator. This intervention will initially include feedback to the subject, psycho-education about his/her alcohol use disorder and currently prescribed study medication. The dose of quetiapine XR will gradually be increased up to a target dose of 400mg/ day over 7 days, maintained as such for seven weeks. This will be followed by a second two night polysomnography study. After the overnight sleep studies the quetiapine will be tapered off, over the next 7 days.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Males and females between the ages of 18-65 years DSM-IV diagnosis of current alcohol dependence Drinking criteria: drinks more than an average of 12 standard drinks/week in the last 30 drinking days.

Can speak, understand, and print in English Is capable of giving written informed consent

Exclusion Criteria:

Positive urine drug screen for opioids, cocaine, or amphetamine (excluding THC) Subject has abused or been dependent on opiates or other psychoactive substances (excluding alcohol, nicotine or occasional use of marijuana) in the past 12 months. Use of prescription opioids prior to treatment entry is allowed at discretion of the PI Hepatocellular disease [as indicated by serum ALT/AST (ALT/AST > 4)] at baseline.

Any current unstable or serious psychiatric condition (e.g. schizophrenia, bipolar disorder, or PTSD) Any unstable or serious medical/neurologic illness including cataracts [posterior capsular/ nuclear (grade NS3 or more)] or epilepsy Regular use of any psychotropic medications/ disulfiram regularly within the last 7 days prior to randomization or needs immediate treatment with a psychotropic medication (except for detoxification medications or benadryl used sparingly for sleep) Subjects who are pregnant, nursing, or not using a reliable method of contraception History of hypersensitivity to antipsychotic drugs, including quetiapine Evidence of severe cognitive impairment Patient with severe sleep apnea (sleep study with an apnea-hypopnea index > 30) on the first night of baseline polysomnograms

Patient with diabetes mellitus meeting one or more of the following criteria:

  • Unstable DM, defined as enrollment glycosylated hemoglobin (HbA1c) > 8.5% -Unstable DM as evidenced by a change in insulin dose of > 10% or recent (< 8 weeks) change in oral hypoglycemic dose
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00434876

Contacts
Contact: Lauren Witte, BA (215) 823-5800 ext 2346 Lauren.Witte@va.gov
Contact: Christopher Cardillo, BS (215) 823-5800 ext 6127 christopher.cardillo@va.gov

Locations
United States, Pennsylvania
Philadelphia, OPC Recruiting
Philadelphia, Pennsylvania, United States, 19106
Contact: Lauren Witte, BA     215-823-5800 ext 2346     Lauren.Witte@va.gov    
Principal Investigator: Subhajit Chakravorty, MD            
Sponsors and Collaborators
Investigators
Principal Investigator: Subhajit Chakravorty, MD Philadelphia, OPC
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs ( Chakravorty, Subhajit - Principal Investigator )
Study ID Numbers: 101206
Study First Received: February 12, 2007
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00434876     History of Changes
Health Authority: United States: Federal Government;   United States: Food and Drug Administration

Keywords provided by Department of Veterans Affairs:
Alcoholism
Insomnia
Quetiapine
Seroquel

Study placed in the following topic categories:
Sleep Initiation and Maintenance Disorders
Tranquilizing Agents
Psychotropic Drugs
Central Nervous System Depressants
Disorders of Environmental Origin
Sleep Disorders
Dyssomnias
Antipsychotic Agents
Sleep Disorders, Intrinsic
Quetiapine
Mental Disorders
Alcoholism
Substance-Related Disorders
Alcohol-Related Disorders
Ethanol

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Tranquilizing Agents
Physiological Effects of Drugs
Nervous System Diseases
Psychotropic Drugs
Central Nervous System Depressants
Disorders of Environmental Origin
Dyssomnias
Sleep Disorders
Antipsychotic Agents
Pharmacologic Actions
Sleep Disorders, Intrinsic
Quetiapine
Mental Disorders
Therapeutic Uses
Alcoholism
Substance-Related Disorders
Alcohol-Related Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009