Comparison of Quetiapine and Trazodone Treatment for Insomnia in Dually Diagnosed Veterans

NCT ID: NCT01662297

Last Updated: 2018-10-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2015-10-31

Brief 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).

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.

Conditions

Insomnia; Mental Health Disorder; Substance Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Quetiapine

Veterans remaining on quetiapine for insomnia.

Group Type: ACTIVE_COMPARATOR

Quetiapine

Intervention Type: DRUG

Quetiapine will be administered at a dosage prescribed by veterans' current providers for the treatment of insomnia.

Trazodone

Veterans switching from quetiapine to trazodone for the treatment of insomnia.

Group Type: ACTIVE_COMPARATOR

Trazodone

Intervention Type: DRUG

Veterans willing to switch from quetiapine to trazodone for the treatment of insomnia will receive up to 400mg of trazodone daily.

Interventions

Quetiapine

Quetiapine will be administered at a dosage prescribed by veterans' current providers for the treatment of insomnia.

Intervention Type: DRUG

Trazodone

Veterans willing to switch from quetiapine to trazodone for the treatment of insomnia will receive up to 400mg of trazodone daily.

Intervention Type: DRUG

Other Intervention Names

Seroquel; Quetiapine Fumarate; Desyrel; Oleptro

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Connecticut Healthcare System

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Albert J Arias, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Yale University/Veterans Affairs CT

Elizabeth Ralevski, Ph.D.

Role: STUDY_DIRECTOR

Yale University/Veterans Affairs CT

Locations

VA Connecticut Healthcare System

West Haven, Connecticut, United States

Countries

United States

Other Identifiers

VA MIRB #01579

Identifier Type: OTHER

Identifier Source: secondary_id

Quetiapine-Trazodone Insomnia

Identifier Type: -

Identifier Source: org_study_id