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Study of the Effectiveness of Quetiapine for the Treatment of Alcohol Dependency

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ClinicalTrials.gov Identifier: NCT00498628
Recruitment Status : Completed
First Posted : July 10, 2007
Results First Posted : May 30, 2012
Last Update Posted : April 25, 2018
Sponsor:
Collaborators:
VA Office of Research and Development
National Institute on Drug Abuse (NIDA)
AstraZeneca
Information provided by (Responsible Party):
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Brief Summary:
The purpose of this study is to determine whether quetiapine fumarate extended release is effective in the treatment of alcohol dependence in very heavy drinkers.

Condition or disease Intervention/treatment Phase
Alcoholism Alcohol Abuse Drug: Quetiapine fumarate Other: Placebo Phase 2

Detailed Description:

This study will investigate quetiapine fumarate XR (SEROQUEL XR®), a dibenzothiazepine derivative, as a potential medication for treating alcohol dependence. The immediate release form of quetiapine fumarate, SEROQUEL XR®, is approved by the FDA for treatment of schizophrenia and acute manic episodes associated with bipolar disorder. The extended release formulation (SEROQUEL XR®) is also approved by the FDA and is undergoing clinical investigation for the treatment of major depressive disorders, schizophrenia, generalized anxiety disorder, and alcohol dependence.

Treatment with other atypical antipsychotics such as clozapine and olanzapine has resulted in decreases in alcohol use in alcohol dependent patients with and without comorbid psychiatric diagnoses. Quetiapine, like clozapine, appears to have efficacy in reducing drug and alcohol use among alcoholics and drug dependent patients with co-morbid psychiatric illness.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Double-Blind, Placebo Controlled Trial to Assess the Efficacy of Quetiapine Fumarate Extended Release for the Treatment of Alcohol Dependence in Very Heavy Drinkers.
Study Start Date : December 2007
Actual Primary Completion Date : August 2009
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
Quetiapine fumarate plus medical management
Drug: Quetiapine fumarate
Quetiapine fumarate- taken daily, for 12 weeks
Other Name: SEROQUEL XR

Placebo Comparator: 2
Medical management plus placebo comparator
Other: Placebo
Placebo




Primary Outcome Measures :
  1. Percent Heavy Drinking Days [ Time Frame: Weeks 3 - 11 ]
    A heavy drinking day is defined as 5 or more drinks for men and 4 or more drinks for women during a 24 hour period.


Secondary Outcome Measures :
  1. Percent Days Abstinent [ Time Frame: 3-11 ]
    Percentage of days abstinent (PDA) between Study Days 15 and 77

  2. Drinks Per Drinking Day [ Time Frame: 3-11 ]
  3. Drinks Per Day [ Time Frame: 3-11 ]
  4. Percent Very Heavy Drinking Day [ Time Frame: 3-11 ]
  5. Percent Subjects Abstinent [ Time Frame: 3-11 ]
  6. Percent Subjects With no Heavy Drinking Day [ Time Frame: 3-11 ]
  7. Drinking Consequences Score [ Time Frame: Weeks 6 and 12 ]
    Drinkers Inventory of Consequences (DrInC) - Alcohol-related problems are determined using the DrInC (Miller et al., 1995). The DrInC is a self-administered 50-item questionnaire designed to measure adverse consequences of alcohol abuse in five areas: Interpersonal, Physical, Social, Impulsive, and Intrapersonal. Each scale provides a lifetime and past 3-month measure of adverse consequences, and scales can be combined to assess total adverse consequences. At baseline the DrInC-2R will be used to assess the 90-day period prior to baseline. For weeks 6 and 12, the DrInC-2R will be used, but will be modified to assess alcohol-related problems over the previous 6-week period.

  8. Penn Alcohol Craving Score (PACS_ [ Time Frame: Week 4, 6, 8, 10, 12 ]
    The Penn Alcohol Craving Scale (PACS) is a five-item, self-report measure that includes questions about the frequency, intensity, and duration of craving, the ability to resist drinking, and asks for an overall rating of craving for alcohol for the previous week (Flannery et al., 1999). Based on clinical study results, the PACS have been shown to be a reliable and valid measure of alcohol craving and can predict subjects at risk for subsequent relapse.

  9. Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Week 4, 6, 8, 10, and 12 ]
    The MADRS is an observer rating scale that has proven to be an efficient and practical measure of depression (Montgomery and Asberg, 1979). The scale was constructed to be sensitive to changes in treatment effects. Its capacity to differentiate between responders and non-responders to antidepressant treatment has been shown to be comparable to the Hamilton Rating Scale for Depression, another established measure of depressive symptomatology, but the MADRS has greater sensitivity to change during the course of a depressive phase. It has exhibited high inter-rater reliability and appears to be oriented more towards psychic as opposed to somatic aspects of depression. The MADRS is a 10-item checklist where items are rated on a scale of 0 to 6 with anchors at 2-point intervals. Scores range from 0 to 60.

  10. Hamilton Anxiety Scale (HAM-A) [ Time Frame: Weeks 4, 6, 8, 10 and 12 ]
    The Hamilton Anxiety Scale consists of 14 items, each defined by a series of symptoms. Similar to the HAM-D, each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe). (Guy, 1976).

  11. Sleep Quality Score [ Time Frame: Weeks 4, 8 and 12 ]
    The Pittsburgh Sleep Quality Index is a 19-item questionnaire with seven sub scales (subjective sleep quality, sleep latency, sleep duration, habitual sleep disturbances, use of sleep medication and day time dysfunction) (Buysse et al., 1989). Each sub-scale is rated from 0-3 with the higher scores reflecting more severe sleep complaints. The addition of all the scores permits an analysis of the subject's overall sleep experience in the past 30 days. The lower the overall score, the better the person sleeps. The tool has an adequate internal reliability, validity and consistency for clinical and community samples of the various populations.

  12. Quality of Life SF - 12 [ Time Frame: Week 12 ]
    The SF-12 will be used to assess overall health status. The SF-12 is a 12-item questionnaire developed in 1994 as a shorter alternative to the SF-36 to reproduce the physical and mental health summary measures with at least 90% accuracy and allows for calculation of the physical and mental component summary scores.



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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:

  • Between the ages of 18 and 65 years old
  • DSM-IV diagnosis of current alcohol dependence as supported by SCID Module E
  • Report "very heavy" drinking (10 or more drinks per drinking day for men or 8 or more drinks per drinking day for women) at least 40% of the days during the interval from day 31 to 90 prior to the initial screening visit (i.e. a total of 24 days of this 60-day period), with at least one day of "very heavy" drinking occurring within the last 2 weeks before screening
  • Seeking treatment for alcohol dependence and desire reduction or cessation of drinking
  • Able to verbalize understanding of the consent form, able to provide written informed consent, and verbalize willingness to complete study procedures
  • Females of child bearing potential must agree to use of at least one approved method of birth control, or must be surgically sterile or postmenopausal
  • Able to take oral medication, willing to adhere to the medication regimen, and willing to return for regular visits
  • Able to understand written and oral instructions in English and to complete the questionnaires required by the protocol
  • Can complete all psychological assessments required at screening and baseline
  • Able to provide evidence of stable residence in the last 2 months prior to randomization, have reasonable transportation arrangements to study site, and have no plans to move within the next 3 months or unresolved legal problems; must provide contact information of family member, spouse, or significant other who can contact subject in case of missed appointment
  • Breath alcohol concentration (BAC) equal to 0.00 when s/he signed the informed consent document
  • Must have an absolute neutrophil count of 1.5 x 109/L or greater.

Exclusion Criteria:

Please contact site for additional information.


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): NCT00498628


Locations
United States, Massachusetts
Boston University School of Medicine, Psychiatry Clinical Studies Unit
Boston, Massachusetts, United States, 02118
United States, New Hampshire
Dartmouth Medical School, Dept. of Psychiatry
Lebanon, New Hampshire, United States, 03755
United States, Pennsylvania
University of Pennsylvania, Treatment Research Center
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
Brown University Center for Alcohol and Addiction Studies
Providence, Rhode Island, United States, 12906
United States, Vermont
White River Junction VA Medical Center
White River Junction, Vermont, United States, 05009
United States, Virginia
University of Virginia, Dept. of Psychiatric Medicine
Charlottesville, Virginia, United States, 22908
University of Virginia
Richmond, Virginia, United States, 23294
Sponsors and Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
VA Office of Research and Development
National Institute on Drug Abuse (NIDA)
AstraZeneca
Investigators
Study Director: Raye Z. Litten, PhD National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Margaret E. Mattson, PhD National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Joanne Fertig, PhD National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Publications of Results:
Responsible Party: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier: NCT00498628     History of Changes
Other Study ID Numbers: NIAAA_DTRR-2007-LITTEN-01
First Posted: July 10, 2007    Key Record Dates
Results First Posted: May 30, 2012
Last Update Posted: April 25, 2018
Last Verified: March 2018

Keywords provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):
Alcoholism
Alcohol dependence
Quetiapine

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Quetiapine Fumarate
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Psychotropic Drugs