Comparison of Quetiapine and Trazodone Treatment for Insomnia in Dually Diagnosed Veterans
Condition: Insomnia; Mental Health Disorder; Substance Use Disorder
MeSH terms: Sleep Initiation and Maintenance Disorders; Substance-Related Disorders; Mental Disorders
Intervention: Quetiapine; Trazodone
Intervention description: Quetiapine will be administered at a dosage prescribed by veterans' current providers for the treatment of insomnia.; Veterans willing to switch from quetiapine to trazodone for the treatment of insomnia will receive up to 400mg of trazodone daily.
Intervention MeSH terms: Quetiapine Fumarate; Trazodone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Quetiapine; Trazodone; Insomnia; Dual Diagnosis

Summary:

      This is a pilot comparative effectiveness study designed to determine whether trazodone is as
      effective as quetiapine for treatment of insomnia in veterans with a history of addiction and
      mental health issues. The study will have two concurrent phases (parts); first an
      acceptability determination phase, to determine whether and why (or why not) veterans already
      taking quetiapine are willing to try an alternative to quetiapine for sleep; and second, a
      randomized trial phase which will test whether staying on quetiapine has any advantage over
      switching to trazodone. The purpose of the first phase will be a) to document the proportions
      of patients and physicians who are willing to agree to such a switch, b) to characterize
      sociodemographic and clinical characteristics of potentially eligible subjects associated
      with a willingness to switch from quetiapine to trazodone and c) to record the reasons given
      why patients and their prescribers are (or are not) willing to accept a switch from
      quetiapine to trazodone. It will also function to provide some educational background to
      patients and a reminder to providers about the potential severe side-effects of quetiapine,
      and will thus facilitate clinical informed consent for the clinical trial phase of the study.
      Completion of the first part of the study will also serve as the screening component for part
      II. Part II includes, first, obtaining written informed consent from eligible subjects, and
      then randomly assigning them to continue quetiapine or to be switched to trazodone in
      open-label "real world" fashion for the duration of 4 weeks, followed by another four weeks
      of open, non-randomized follow- up. The purpose of the second part of the study is to
      determine if trazodone is an adequate substitute for quetiapine, primarily in terms of
      treating insomnia. The investigators hypothesize that trazodone will not be inferior to
      quetiapine in maintaining good quality of sleep measured by sleep scales (i.e., scores will
      not significantly worsen once switched). This study is open to Veterans in the VA system
      only. Eligible subjects must have a history of "dual diagnosis" (i.e., a history of addiction
      and mental illness).
    

Eligibility criteria:

        Inclusion/Exclusion Criteria (PHASE 1):

          -  Identified by their VA prescribing provider as taking quetiapine primarily as a
             sedative/hypnotic agent for some form of insomnia for at least 1 month

          -  Identified by their VA prescribing provider as having dual diagnosis; a lifetime
             history of substance use disorder and a mental disorder

          -  Willing to meet with a research assistant to answer several questions regarding their
             use of and experience with quetiapine.

          -  Appear not to be regularly on any medication which would be an exclusion for Part II
             (see Part II exclusion criteria).

        Inclusion Criteria (PHASE 2):

          -  Willing to provide written informed consent.

          -  Provider reports that primary use of quetiapine is for insomnia for at least one month
             and not primary or augmentation treatment of mood, anxiety disorder, psychosis, or
             mood stabilization.

          -  Have a self-identified and provider confirmed lifetime history of mental health and
             substance use disorder (dual diagnosis).

          -  Currently taking Quetiapine up to 300mg daily for the primary purpose of treating
             insomnia, and have been taking it for at least 1 month (30 days).

          -  Use of an acceptable method of birth control by female patients who have a possibility
             of becoming pregnant.

          -  The provider should review the patients from the identified charts, and fill out
             information about the patient and why they are on the drug, and provider should
             consent to us approaching the client and potentially switching them; the investigators
             will not approach and begin enrollment for part II on subjects if their provider feels
             it is not appropriate for them for any reason.

        Exclusion Criteria (PHASE 2):

          -  Physiologic substance dependence requiring detoxification in the past 30 days
             (substance abuse is not an exclusion).

          -  Concomitant administration of: other sedative hypnotics, benzodiazepines, prazosin,
             other atypical antipsychotics, stimulants, ketoconazole and other inhibitors of
             cytochrome P450 3A (e.g., itraconazole, fluconazole, erythromycin, and protease
             inhibitors), phenytoin or other strong inducers of cytochrome P450 enzymes.

          -  Intolerance or hypersensitivity to trazodone.

          -  Pregnant or lactating women or women planning to become pregnant.

          -  Hepatic or renal problems AST or ALT (>3 times upper limit of normal);

          -  Elevated bilirubin (>1.2), BUN (>24), creatinine (>1.7).

          -  Unstable, serious medical condition or one requiring acute medical treatment, or
             anticipation of hospitalization for extended care.

          -  Dementia, epilepsy, insulin-dependent diabetes, anticoagulation with coumadin.

          -  Legal entanglements or pending legal charges with potential of incarceration.

          -  Recent (i.e., past 3 months) assault or suicide gesture currently needing acute
             intervention.

          -  Concurrent participation in another clinical trial with an investigational drug during
             the last 30 days.