Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Massachusetts General Hospital
OBJECTIVES: * 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.
Age
18–65
Sex
FEMALE
Healthy volunteers
Not accepted