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Trial record 87 of 115 for:    ZOLPIDEM AND AIDS

Venlafaxine With or Without Zolpidem in Treating Hot Flashes and Associated Sleep Disorders in Women With Breast Cancer OR at High Risk for Developing Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00084669
Recruitment Status : Completed
First Posted : June 11, 2004
Last Update Posted : April 28, 2010
Information provided by:
Massachusetts General Hospital

Brief Summary:

RATIONALE: Venlafaxine may be effective in relieving hot flashes caused by hormone therapy. Giving venlafaxine with zolpidem (a sleeping pill) may improve sleep and quality of life in women who are receiving hormone therapy for treatment or prevention of breast cancer.

PURPOSE: This randomized clinical trial is studying giving venlafaxine together with zolpidem to see how well it works compared to venlafaxine alone in relieving hot flashes and associated sleep disorders in women who are receiving hormone therapy to treat or prevent breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Hot Flashes Sleep Disorders Drug: venlafaxine Drug: zolpidem tartrate Procedure: management of therapy complications Not Applicable

Detailed Description:


  • Compare the effect of venlafaxine or another serotonin-reuptake inhibitor with vs without zolpidem, in terms of sleep continuity, in women with breast cancer or at high risk for developing breast cancer who experience hot flushes and associated sleep disorders.
  • Compare quality of life in patients treated with these regimens.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified by concurrent use of serotonin-reuptake inhibitors (SRI).

  • Stratum 1 (no concurrent SRI): Patients are randomized to 1 of 2 treatment arms.

    • Arm I: Patients receive oral venlafaxine once daily and oral zolpidem once daily for 5 weeks*.
    • Arm II: Patients receive oral venlafaxine once daily and oral placebo once daily for 5 weeks*.
  • Stratum 2 (concurrently on SRI): Patients are randomized to 1 of 2 treatment arms.

    • Arm I: Patients receive oral zolpidem once daily for 5 weeks*.
    • Arm II: Patients receive oral placebo once daily for 5 weeks*. NOTE: *After 5 weeks of study treatment, patients in stratum 1 may taper or continue venlafaxine over 2 weeks (for a total duration of venlafaxine use of 7 weeks); patients in arm I of both strata may taper or continue zolpidem over 1 week (for a total duration of zolpidem use of 6 weeks); continuation or tapering of drugs in both arms occurs in an open-label fashion off study.

In both strata, treatment continues in the absence of unacceptable toxicity.

In both strata, hot flushes, sleep continuity, sleep quality, and quality of life are assessed at baseline and at weeks 1, 3, and 6.

PROJECTED ACCRUAL: A total of 119 patients will be accrued for this study within 20 months.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 119 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Supportive Care
Official Title: Targeting Insomnia to Enhance Hot Flush Treatment in Women Receiving Therapy for Breast Cancer or Breast Cancer Risk-Reduction
Study Start Date : May 2004
Actual Primary Completion Date : October 2007
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Primary Outcome Measures :
  1. Sleep improvement by biologic data and actigraphy data at the end of study treatment

Secondary Outcome Measures :
  1. Quality of life by BDI, QOLI, PSI, NCCTG symptom diary, PSQI, MOS SF-36 at the end of study treatment

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • At increased risk of developing breast cancer, meeting 1 of the following criteria:

    • Diagnosis of 1 of the following:

      • Ductal carcinoma in situ
      • Invasive breast cancer
      • Lobular carcinoma in situ
      • Atypical ductal or lobular hyperplasia
      • Lobular carcinoma
    • Candidate for breast cancer risk reduction for any of the following:

      • Predisposing mutation in a breast cancer susceptibility gene
      • Prior chest radiotherapy for Hodgkin's disease
      • Gail model score > 1.67% over 5 years
  • Experiencing daytime and nocturnal hot flushes at least 14 times per week within the past 2 weeks
  • Experiencing sleep disturbance, characterized by the presence of all of the following for ≥ 1 month:

    • ≥ 3 awakenings per night occurring ≥ 3 nights per week
    • Insomnia impedes daytime function
    • Hot flushes are the primary cause of insomnia (determined at baseline visit)
  • Hormone receptor status:

    • Not specified



  • 18 to 65


  • Female

Menopausal status

  • Not specified

Performance status

  • ECOG 0-1

Life expectancy

  • At least 6 months


  • Not specified


  • AST and ALT ≤ 2.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 times ULN


  • Creatinine ≤ 1.5 times ULN


  • No clinically significant cardiac disease
  • No uncontrolled hypertension within the past 3 months, defined as the following:

    • Diastolic blood pressure > 95 mm Hg on > 1 occasion
    • Systolic blood pressure > 160 mm Hg on > 1 occasion


  • No clinically significant respiratory disease


  • Beck depression inventory score ≤ 15
  • No active panic or depressive disorder within the past month
  • No lifetime history of bipolar or psychotic disorder
  • No active substance-use disorders, including alcohol and benzodiazepines, within the past year
  • No suicidal or homicidal ideation
  • No hypomania or mania


  • No prior adverse reaction to venlafaxine or zolpidem
  • None of the following sleep disorders within the past 6 months:

    • Sleep apnea
    • Narcolepsy
    • Periodic limb movement disturbance
  • No abuse or misuse of study medication
  • No daytime sedation that interferes with ability to function
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and for 1 month after study participation


Biologic therapy

  • Not specified


  • More than 3 months since prior chemotherapy
  • No concurrent chemotherapy

Endocrine therapy

  • More than 1 month since prior regular use (> 25% of the time) of oral, transdermal, or injection preparations of androgens, estrogens, or progestins

    • Vaginal suppositories and creams allowed
  • No concurrent regular use of oral, transdermal, or injection preparations of androgens, estrogens, or progestins


  • See Disease Characteristics
  • More than 3 months since prior radiotherapy
  • No concurrent radiotherapy


  • See Disease Characteristics


  • More than 1 month since prior regular use (> 25% of the time) of any of the following:

    • Hypnotic agents (e.g., benzodiazepines, zolpidem, zaleplon, trazodone, or diphenhydramine)
    • Clonidine
  • More than 1 month since prior antidepressants or other medications that are known to influence mood > 25% of the time (no serotonin-reuptake inhibitors [SRI] stratum only)
  • Concurrent SRI required provided they were initiated ≥ 1 month ago at or above the minimum dose, including any of the following (concurrent SRI stratum only):

    • Fluoxetine
    • Paroxetine
    • Paroxetine CR
    • Sertraline
    • Citalopram
    • S-citalopram
    • Venlafaxine
    • Fluvoxamine
  • No concurrent warfarin
  • No concurrent hypnotic agents, clonidine, or antidepressants, or other medications known to influence sleep, or mood

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00084669

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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115-6084
Sponsors and Collaborators
Massachusetts General Hospital
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Study Chair: Hadine Joffe, MD, MSC Massachusetts General Hospital
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Responsible Party: Hadine Joffe, MD, Massachusetts General Hospital Identifier: NCT00084669    
Other Study ID Numbers: CDR0000365502
First Posted: June 11, 2004    Key Record Dates
Last Update Posted: April 28, 2010
Last Verified: April 2010
Keywords provided by Massachusetts General Hospital:
hot flashes
sleep disorders
ductal breast carcinoma in situ
breast cancer in situ
lobular breast carcinoma in situ
lobular breast carcinoma
recurrent breast cancer
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer
Additional relevant MeSH terms:
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Sleep Aids, Pharmaceutical
Breast Neoplasms
Sleep Wake Disorders
Hot Flashes
Neoplasms by Site
Breast Diseases
Skin Diseases
Nervous System Diseases
Neurologic Manifestations
Mental Disorders
Venlafaxine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Hypnotics and Sedatives
Central Nervous System Depressants
GABA-A Receptor Agonists
GABA Agonists
GABA Agents