Clinical trial NCT00498628: Study of the Effectiveness of Quetiapine for the Treatment of Alcohol Dependency
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcoholism
Alcohol Abuse
Keywords: Alcoholism
Alcohol dependence
Quetiapine
Lead sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Sponsor class: NIH
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: AstraZeneca
name: US Department of Veterans Affairs
First posted: 2007-07-10
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Percent Heavy Drinking Days
timeFrame: Weeks 3 - 11
Secondary outcomes:
measure: Percent Days Abstinent
timeFrame: Weeks 3-11
measure: Drinks Per Drinking Day
timeFrame: Study Weeks 3-11
measure: Drinks Per Day
timeFrame: Study Weeks 3-11
measure: Percent Very Heavy Drinking Day
timeFrame: Study Weeks 3-11
measure: Percent Subjects Abstinent
timeFrame: Study Weeks 3-11
measure: Percent Subjects With no Heavy Drinking Day
timeFrame: Study Weeks 3-11
measure: Drinking Consequences Score
timeFrame: Weeks 6 & 12
measure: Penn Alcohol Craving Score (PACS_
timeFrame: Weeks 4, 6, 8, 10, and 12
measure: Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: Weeks 3-11
measure: Hamilton Anxiety Scale (HAM-A)
timeFrame: Weeks 4, 6, 8, 10, and 12
measure: Pittsburgh Sleep Quality Score
timeFrame: Weeks 4, 8, 12
measure: Quality of Life SF - 12 - Mental Aggregate Score
timeFrame: Week 12
measure: Quality of Life SF-12 - Physical Aggregate Score
timeFrame: Week 12
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University School of Medicine, Psychiatry Clinical Studies Unit
state: Massachusetts
city: Lebanon
country: United States
facility: Dartmouth Medical School, Dept. of Psychiatry
state: New Hampshire
city: Philadelphia
country: United States
facility: University of Pennsylvania, Treatment Research Center
state: Pennsylvania
city: Providence
country: United States
facility: Brown University Center for Alcohol and Addiction Studies
state: Rhode Island
city: White River Junction
country: United States
facility: White River Junction VA Medical Center
state: Vermont
city: Charlottesville
country: United States
facility: University of Virginia, Dept. of Psychiatric Medicine
state: Virginia
city: Richmond
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: Raye Z. Litten, PhD
role: STUDY_DIRECTOR
affiliation: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: Margaret E. Mattson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: Joanne Fertig, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.