Management of Insomnia in Breast Cancer Patients

Not Recruiting

Trial ID: NCT01011218


To provide preliminary data on the effects of brief behavioral therapy for insomnia (BBT-I) on insomnia in breast cancer patients expecting to receive cancer treatment (unspecified). Participants will be randomized into 4 groups: * Arm 1: Brief Behavioral Treatment of Insomnia (BBT-I) + Armodafinil 150 mg/day. * Arm 2: Behavioral therapy for insomnia (CBT-I) + Armodafinil 150 mg/day. * Arm 3: Brief Behavioral Treatment of Insomnia (BBT-I) without pharmaceutical intervention. * Arm 4: Behavioral therapy for insomnia (CBT-I) without pharmaceutical intervention.

Official Title

Management of Insomnia in Breast Cancer Patients: A Preliminary Pilot Study

Stanford Investigator(s)

David Spiegel
David Spiegel

Jack, Lulu and Sam Willson Professor of Medicine

Frank E. Stockdale
Frank E. Stockdale

Maureen Lyles D'Ambrogio Professor in the School of Medicine, Emeritus



* Be scheduled for cancer treatment with chemotherapy or biologics (prior chemotherapy and/or diagnosis of metastatic breast are allowed)
* Have at least 6 weeks of treatment remaining
* ≥ 21 years old
* Able to understand written and spoken English
* Able to swallow medication (until amendment omitting armodafinil treatment)
* Score of 3+ on the Sleep Disruption Evaluation form, OR a score of 8+ on Insomnia Severity Index (ISI)


* Prior treatment with armodafinil or modafinil (until amendment omitting armodafinil treatment)
* Prior treatment with psycho-stimulant medication within the past 28 days (until amendment omitting armodafinil treatment)
* Prior treatment with antiseizure medications (until amendment omitting armodafinil treatment)
* Has continuously taken sleep medication daily for the last 28 days (until amendment omitting armodafinil treatment)
* History (self-reported) of unstable medical or psychiatric illness (within the last 5 years)
* History of uncontrolled, cardiac disease, hypertension, severe headaches, glaucoma, or seizures (until amendment omitting armodafinil treatment)
* Pregnant or nursing
* History of substance abuse or meet criteria for current alcohol abuse or dependence
* History (self-reported) of chronic, preexisting insomnia, sleep apnea, or restless leg syndrome (RLS)
* Severe hepatic impairment (until amendment omitting armodafinil treatment)


drug: Armodafinil

behavioral: BBT-I

behavioral: Control

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Oxana Palesh, PhD, MPH

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