A Study of Quetiapine and Mirtazapine for the Treatment of Alcohol Dependency
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to test whether taking two medicines (quetiapine and mirtazapine)
      is better for helping people to decrease drinking than taking one medicine alone
      (quetiapine).
    

Detailed description: 
      Alcohol dependence is a debilitating illness affecting almost 8 million people annually and
      for which the current FDA approved medications are only modestly effective in reducing
      relapse or drinking. Because alcohol dependence is such a common, devastating disease,
      researchers continue to search for new treatments that could be more effective and better
      tolerated. The development and testing of medications that target brain systems involved in
      alcohol dependence is of acute interest to patients, clinicians and researchers.

      Studies by our group in animals have suggested that medications with a combination of a weak
      dopamine D2 receptor antagonism, a potent norepinephrine alpha 2 receptor antagonism, and
      norepinephrine reuptake inhibition decrease alcohol drinking. Quetiapine is a weak D2
      antagonist and a moderate alpha 2 receptor antagonist, and its primary metabolite,
      desalkylquetiapine, is a norepinephrine reuptake inhibitor, this medication is likely to have
      some ability to decrease alcohol drinking. But, when combined with mirtazapine, a potent
      alpha 2 antagonist, the combination should potently decrease alcohol drinking. The proposed
      study is based on this theoretical formulation, as well as on clinical studies of quetiapine
      and mirtazapine used independently.

      This is an open-label, sequential design study with one group of approximately 20 subjects
      studied under two treatment conditions; quetiapine alone and quetiapine + mirtazapine. The
      primary objective is to assess the efficacy of quetiapine fumarate extended-release (XR)
      alone vs. quetiapine fumarate XR in combination with mirtazapine in reducing the weekly
      percentage of days of heavy drinking (5 or more drinks per drinking day for men, 4 or more
      drinks per drinking day for women) in subjects meeting DSM-IV criteria for alcohol
      dependency.

      Participants will begin with quetiapine fumarate XR up to a target dose of 400 mg and will
      receive 16 weeks of treatment with quetiapine. At week 8 subjects will begin 9 weeks of
      mirtazapine added to their existing regimen of quetiapine treatment. Participants will also
      meet with a medical provider at each visit to encourage compliance with study medication and
      attending study visits, review adverse events, and set goals for reduction of drinking.
      Analyses will assess whether treatment with quetiapine in combination with mirtazapine
      reduces drinking more than treatment with quetiapine alone.
    

Intervention name(s): Mirtazapine; Quetiapine fumarate extended release (Quetiapine XR)
Intervention type(s): Drug; Drug
Intervention description(s): mirtazapine (7.5-45mg); Quetiapine fumarate extended release 50-400mg/d
Other intervention name(s): mirtazapine (Remeron); quetiapine XR, Seroquel XR
Intervention MeSH terms: Quetiapine Fumarate; Mirtazapine
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment