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

Information source: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alcoholism; Alcohol Abuse

Intervention: Quetiapine fumarate (Drug); Placebo (Other)

Phase: Phase 2

Status: Completed

Sponsored by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Official(s) and/or principal investigator(s):
Raye Z. Litten, PhD, Study Director, Affiliation: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Margaret E. Mattson, PhD, Principal Investigator, Affiliation: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Joanne Fertig, PhD, Principal Investigator, Affiliation: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Percent Heavy Drinking Days

Secondary outcome:

Percent Days Abstinent

Drinks Per Drinking Day

Drinks Per Day

Percent Very Heavy Drinking Day

Percent Subjects Abstinent

Percent Subjects With no Heavy Drinking Day

Drinking Consequences Score

Craving Score

Depression Score

Anxiety Score

Sleep Quality Score

Quality of Life Score

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.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Locations and Contacts

Boston University School of Medicine, Psychiatry Clinical Studies Unit, Boston, Massachusetts 02118, United States

Dartmouth Medical School, Dept. of Psychiatry, Lebanon, New Hampshire 03755, United States

University of Pennsylvania, Treatment Research Center, Philadelphia, Pennsylvania 19104, United States

Brown University Center for Alcohol and Addiction Studies, Providence, Rhode Island 12906, United States

White River Junction VA Medical Center, White River Junction, Vermont 05009, United States

University of Virginia, Dept. of Psychiatric Medicine, Charlottesville, Virginia 22908, United States

University of Virginia, Richmond, Virginia 23294, United States

Additional Information

Starting date: December 2007
Last updated: June 17, 2015

Page last updated: August 23, 2015

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