Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2025-12-24 @ 11:00 PM
NCT ID:
NCT00084669
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* 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
PATIENT CHARACTERISTICS:
Age
* 18 to 65
Sex
* Female
Menopausal status
* Not specified
Performance status
* ECOG 0-1
Life expectancy
* At least 6 months
Hematopoietic
* Not specified
Hepatic
* AST and ALT ≤ 2.5 times upper limit of normal (ULN)
* Bilirubin ≤ 1.5 times ULN
Renal
* Creatinine ≤ 1.5 times ULN
Cardiovascular
* 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
Pulmonary
* No clinically significant respiratory disease
Psychiatric
* 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
Other
* 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
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* 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
Radiotherapy
* See Disease Characteristics
* More than 3 months since prior radiotherapy
* No concurrent radiotherapy
Surgery
* See Disease Characteristics
Other
* 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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00084669
Study Brief:
Protocol Section:
NCT00084669