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.
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 224
- Locations
- 7
- Primary Endpoint
- Percent Heavy Drinking Days
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
1
Quetiapine fumarate plus medical management
Intervention: Quetiapine fumarate (Drug)
2
Medical management plus placebo comparator
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
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 Outcomes
- Percent Days Abstinent(Weeks 3-11)
- Drinks Per Drinking Day(Study Weeks 3-11)
- Percent Subjects With no Heavy Drinking Day(Study Weeks 3-11)
- Hamilton Anxiety Scale (HAM-A)(Weeks 4, 6, 8, 10, and 12)
- Drinks Per Day(Study Weeks 3-11)
- Percent Subjects Abstinent(Study Weeks 3-11)
- Penn Alcohol Craving Score (PACS_(Weeks 4, 6, 8, 10, and 12)
- Pittsburgh Sleep Quality Score(Weeks 4, 8, 12)
- Percent Very Heavy Drinking Day(Study Weeks 3-11)
- Montgomery-Asberg Depression Rating Scale (MADRS)(Weeks 3-11)
- Quality of Life SF - 12 - Mental Aggregate Score(Week 12)
- Drinking Consequences Score(Weeks 6 & 12)
- Quality of Life SF-12 - Physical Aggregate Score(Week 12)