Trial of Seroquel SR for Alcohol Dependence and Comorbid Anxiety
Condition: Alcoholism; Anxiety Disorders; Generalized Anxiety Disorder; Post-Traumatic Stress Disorder; Panic Disorder; Obsessive-Compulsive Disorder
MeSH terms: Alcoholism; Anxiety Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Obsessive-Compulsive Disorder; Panic Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      Alcohol use disorders (AUDs) are a major problem facing our society. Their treatment is
      complex, and involves multiple behavioral and pharmacotherapy interventions. There are 3
      approved medications for AUDs, but their efficacy for AUDs that co-exist with anxiety
      disorders is unknown. This study explores the effects of the medication, sustained-release
      quetiapine fumarate (Seroquel SR) for the treatment of alcohol dependence and co-morbid
      anxiety. Primary outcome measure is the amount of alcohol used. Secondary outcome measures
      include craving for alcohol, length of sobriety from drinking and level of anxiety with
      Seroquel SR.
    

Detailed description: 
      STUDY OBJECTIVES:

      The objective of this proposal is to study the efficacy of the medication Seroquel SR for the
      treatment of alcohol dependence and co-morbid anxiety in a prospective double blind
      placebo-controlled randomized clinical study. Patients, meeting the DSM-IV criteria for
      Alcohol Dependence and an Anxiety Disorder, will be enrolled and randomized to receive
      placebo or Seroquel SR. All subjects will be referred to usual treatment program, where they
      can receive group/self help group therapy.

      Method:

      This is a 12-week prospective, double blind placebo-controlled randomized clinical trial of
      Seroquel SR in patients who meet the Diagnostic and Statistical Manual of Psychiatric
      Disorders (DSM-IV) criteria for alcohol dependence and anxiety disorders. Potential
      candidates will be allowed sufficient time to review the consent document and ask questions
      about the trial prior to signing the consent document. Consenting adults will be randomized
      to receive active medication, Seroquel SR or placebo for 12-weeks. The study will enroll 20
      patients, 10 will be randomized to receive Seroquel SR, and 10 will receive placebo. All
      participants will also be referred to usual alcohol treatment, including individual, group
      and/or self help group therapy (Alcoholics Anonymous).

      Subjects will be randomized to receive either Seroquel SR or placebo. Dosing of Seroquel SR
      will occur on the following schedule: At the baseline visit, Seroquel SR will be started at
      50 mg QHS for Day 1 and 2, and dose increase to 150 mg QHS on day 3-4, and increased further
      to 300 mg QHS from day 5-day 42. After day 5, the Seroquel SR dosage can be increased by up
      to 100 mg per week to a maximal dose of 400 mg per day. During the treatment period, dose
      reductions (because of physical illness or adverse event) are allowed for patients taking at
      least 200 mg per day.
    

Intervention name(s): Seroquel XR
Intervention type(s): Drug
Intervention description(s): Day 1 and 2 Seroquel XR 50 mg; Day 3-4 Seroquel XR 150mg;Day 5-42 Seroquel XR 300-400mg
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Alcoholism; Anxiety; GAD; PTSD; Panic Disorder; OCD