NCT00498628

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
224

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2007

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 10, 2007

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

May 30, 2012

Completed
Last Updated

March 19, 2019

Status Verified

February 1, 2019

Enrollment Period

1.7 years

First QC Date

July 6, 2007

Results QC Date

April 25, 2012

Last Update Submit

February 26, 2019

Conditions

AlcoholismAlcohol Abuse

Keywords

AlcoholismAlcohol dependenceQuetiapine

Outcome Measures

Primary Outcomes (1)

  • Percent Heavy Drinking Days

    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.

    Weeks 3 - 11

Secondary Outcomes (13)

  • Percent Days Abstinent

    Weeks 3-11

  • Drinks Per Drinking Day

    Study Weeks 3-11

  • Drinks Per Day

    Study Weeks 3-11

  • Percent Very Heavy Drinking Day

    Study Weeks 3-11

  • Percent Subjects Abstinent

    Study Weeks 3-11

  • +8 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Quetiapine fumarate plus medical management

Drug: Quetiapine fumarate

2

PLACEBO COMPARATOR

Medical management plus placebo comparator

Other: Placebo

Interventions

Quetiapine fumarateDRUG

Quetiapine fumarate- taken daily, for 12 weeks

Also known as: SEROQUEL XR
1
PlaceboOTHER

Placebo

2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Please contact site for additional information.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Boston University School of Medicine, Psychiatry Clinical Studies Unit

Boston, Massachusetts, 02118, United States

Location

Dartmouth Medical School, Dept. of Psychiatry

Lebanon, New Hampshire, 03755, United States

Location

University of Pennsylvania, Treatment Research Center

Philadelphia, Pennsylvania, 19104, United States

Location

Brown University Center for Alcohol and Addiction Studies

Providence, Rhode Island, 12906, United States

Location

White River Junction VA Medical Center

White River Junction, Vermont, 05009, United States

Location

University of Virginia, Dept. of Psychiatric Medicine

Charlottesville, Virginia, 22908, United States

Location

University of Virginia

Richmond, Virginia, 23294, United States

Location

Related Publications (2)

  • Litten RZ, Fertig JB, Falk DE, Ryan ML, Mattson ME, Collins JF, Murtaugh C, Ciraulo D, Green AI, Johnson B, Pettinati H, Swift R, Afshar M, Brunette MF, Tiouririne NA, Kampman K, Stout R; NCIG 001 Study Group. A double-blind, placebo-controlled trial to assess the efficacy of quetiapine fumarate XR in very heavy-drinking alcohol-dependent patients. Alcohol Clin Exp Res. 2012 Mar;36(3):406-16. doi: 10.1111/j.1530-0277.2011.01649.x. Epub 2011 Sep 26.

    PMID: 21950727RESULT

  • Vatsalya V, Kong M, Marsano LM, Kurlawala Z, Chandras KV, Schwandt ML, Ramchandani VA, McClain CJ. Interaction of Heavy Drinking Patterns and Depression Severity Predicts Efficacy of Quetiapine Fumarate XR in Lowering Alcohol Intake in Alcohol Use Disorder Patients. Subst Abuse. 2020 Sep 9;14:1178221820955185. doi: 10.1177/1178221820955185. eCollection 2020.

    PMID: 32963470DERIVED

MeSH Terms

Conditions

Alcoholism

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

DibenzothiazepinesThiazepinesThiepinsSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Dr. Raye Litten
Organization
NIAAA
301-443-0636

Study Officials

  • Raye Z. Litten, PhD

    National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    STUDY DIRECTOR

  • 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)

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2007

First Posted

July 10, 2007

Study Start

December 1, 2007

Primary Completion

August 1, 2009

Study Completion

March 1, 2010

Last Updated

March 19, 2019

Results First Posted

May 30, 2012

Record last verified: 2019-02

Locations

US(7)