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

July 9, 2013 updated by: Subhajit Chakravorty

The Effects of Quetiapine on Sleep During Alcohol Abstinence

The primary purpose of this study is to determine how efficacy of quetiapine (seroquel XR) in improving the sleep in recovering alcohol dependent subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19106
        • Philadelphia, OPC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Placebo
Drug: Placebo.
Inactive or inert pill which will be used as a comparator.
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 Names:
  • Seroquel XR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 (%).
Baseline, and week 8 of treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, weeks 1, 3, 5, and 7 of treatment.
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.
Baseline, 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).
Baseline, and week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Subhajit Chakravorty

Investigators

  • Principal Investigator: Subhajit Chakravorty, MD, Philadelphia, OPC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

February 12, 2007

First Submitted That Met QC Criteria

February 13, 2007

First Posted (Estimate)

February 14, 2007

Study Record Updates

Last Update Posted (Estimate)

August 9, 2013

Last Update Submitted That Met QC Criteria

July 9, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 101206

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Alcoholism

Clinical Trials on Quetiapine XR

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Morocco

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe