Comparison of Quetiapine and Trazodone Treatment for Insomnia in Dually Diagnosed Veterans
Information source: VA Connecticut Healthcare System
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Insomnia; Mental Health Disorder; Substance Use Disorder
Intervention: Quetiapine (Drug); Trazodone (Drug)
Phase: Phase 4
Status: Enrolling by invitation
Sponsored by: VA Connecticut Healthcare System Official(s) and/or principal investigator(s): Albert J Arias, MD, MS, Principal Investigator, Affiliation: Yale University/Veterans Affairs CT Elizabeth Ralevski, Ph.D., Study Director, Affiliation: Yale University/Veterans Affairs CT
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).
Clinical Details
Official title: Comparison of Quetiapine and Trazodone Treatment for Insomnia in Dually Diagnosed Veterans: an Open (e.g. Unblinded) Randomized Stay-Switch Pilot Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change in average Pittsburgh Sleep Quality Inventory (PSQI)score
Secondary outcome: Change in Medical Outcomes Study Sleep Scale (MOS-SS)over timeChange in Epworth Sleepiness Scale (ESS) over time Change in RAND Short Form 36 Item Health Survey (RAND-SF36) over time Change in Brief Symptom Inventory (BSI)over time Change in Alcohol Urge Questionnaire (AUQ)scores over time Percentage of heavy drinking days Percentage of negative urine drug screens
Detailed description:
Part I of the study involves identification through VA records of subjects eligible for the
study based on their prescription of quetiapine. Potentially eligible subjects will be
contacted by the research team. Subjects will answer a brief questionnaire about their
experience with the medication quetiapine as used for insomnia. If subjects are interested
in participated in part II, the clinical trial portion of the study, they will be further
screened for eligibility.
Part II consists of a 4 week clinical trial in which subjects are randomized to stay on
quetiapine or switch to trazodone, all of which will be open-label. Subjects will be
evaluated for symptoms of sleep quality and excessive daytime sleepiness. subjects will also
be assessed for changes in mood, and alcohol/drug use. After the initial 4 week treatment
period, subjects on trazodone can choose to switch back to quetiapine or continue on
trazodone. Subjects will also be evaluated after an additional 4 weeks (8weeks from start of
the study) on outcome measures.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
VA Connecticut Healthcare System, West Haven, Connecticut 06516, United States
Additional Information
Starting date: July 2012
Last updated: August 10, 2012
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