NCT00498628

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

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 224 (actual)
• Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA) · NIH
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alcoholism
• Alcohol Abuse

Interventions

Type	Name	Description
DRUG	Quetiapine fumarate	Quetiapine fumarate- taken daily, for 12 weeks
OTHER	Placebo	Placebo

Timeline

• Start date: 2007-12-01
• Primary completion: 2009-08-01
• Completion: 2010-03-01
• First posted: 2007-07-10
• Last updated: 2019-03-19
• Results posted: 2012-05-30

Locations

7 sites across 1 country: United States