Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Antineoplastic Agents

Central Nervous System Depressants

Anti-Allergic Agents

Antiemetics

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Zolpidem

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Promethazine

Hypnotics and Sedatives

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Neurotransmitter Agents

5 mg oral dose of zolpidem prior to undergoing ADT followed by 5 mg oral dose of zolpidem after ADT and testosterone reaches castrate levels

In men with prostate cancer, males (pre-castration, n=8-10) will receive oral zolpidem in the form of a 5 mg tablet. Blood samples will be collected for pharmacokinetic analysis at pre-dose and 0.5, 1, 2, 4, and 8-hours post-dose. This cohort of men will then undergo androgen deprivation therapy with standard doses of goserelin. When castrate testosterone levels reach \<50 ng/dL (post-castration), they will receive another 5 mg single dose of zolpidem followed by 8-hr PK evaluation of zolpidem and its metabolites. Normal healthy females (n=5-8) will receive treatment with a single dose of 5 mg tablet of zolpidem followed by 8-hr PK evaluation of zolpidem and its metabolites. Blood samples will be collected for PK analysis at pre-dose and 0.5, 1, 2, 4, and 8-hours post-dose.

Deneise Francis, R.N.

William D Figg, Pharm.D.

For more information at the NIH Clinical Center contact National Cancer Institute Referral Office

Background:

Insomnia is associated with difficulty sleeping. The drug zolpidem is widely prescribed for insomnia. Women have reported worse effects from the drug than men. Women have higher amounts of zolpidem in their body that may persist after waking. Drug exposure may also depend on male hormones that change during prostate cancer therapy. Researchers want to see if these findings can provide a more-accurate dose to healthy women and men with prostate cancer.

Objective:

To study amounts of zolpidem in men who have been diagnosed with prostate cancer before they are castrated and after, and to compare these results to healthy women s.

Eligibility:

Men ages 18 and older who have been diagnosed with prostate cancer who are planning to receive androgen deprivation therapy (ADT)

Healthy women age 18 and older

Design:

Participants will be screened with:

Blood tests

Physical exam

Electrocardiogram (EKG) heart test

Male participants will confirm their prostate cancer. This can be done with a tumor sample tissue from a previous surgery or a report from a doctor.

Female participants may have a pregnancy test.

Participants will be admitted to the clinic in the evening and stay overnight. They will:

Take a 5 mg zolpidem tablet on an empty stomach around 11 p.m.

Have blood drawn multiple times

Have physical exams and EKGs

Answer questions about their symptoms and medicines they are taking

Male participants will have ADT as part of their standard cancer treatment. After that, the testosterone in their blood will be measured. They will repeat the overnight clinic stay.

Participants will get a follow-up phone call after each stay.

Background:

* Zolpidem is currently approved for the treatment of patients with insomnia.
* Women reported experiencing an increased incidence of adverse effects than men, resulting in a reduction of the recommended dose of zolpidem for women.
* Zolpidem metabolism is affected by both age and gender; the recommended dose for the elderly and female populations is 5mg daily.
* Subsequent studies have shown that women experience greater exposure to zolpidem than men, potentially due to androgen-driven differences in enzyme expression.
* A preclinical study showed that castrated male rats exhibited zolpidem pharmacokinetics similar to that of female rats, providing further evidence to suggest that zolpidem pharmacokinetics are androgen-driven.

Objectives:

-To evaluate the effect of castration on the pharmacokinetics of a single 5-mg dose of zolpidem in participants with prostate cancer undergoing androgen deprivation therapy (prevs. post-castration therapy) compared to normal healthy females.

Eligibility:

* Participants with prostate cancer (rising PSA and greater than or equal to 100 ng/dL)
* Females in good health condition or without significant diseases
* After androgen deprivation therapy, castrate testosterone levels \<50 ng/dL
* ECOG 0-1

Design:

* Comparative, single-dose pharmacokinetic study.
* Men with prostate cancer (pre-castration) and normal healthy females will receive treatment with a single dose of 5 mg tablet of zolpidem followed by 8-hour pharmacokinetic evaluation of zolpidem and its metabolites.
* Men will then undergo androgen deprivation therapy and when castrate testosterone levels \<50 ng/dL (post-castration), they will receive another 5 mg single dose of zolpidem followed by 8-hour pharmacokinetic evaluation of zolpidem and its metabolites.
* Normal healthy females will receive treatment with a single dose of 5 mg tablet of zolpidem followed by 8-hour pharmacokinetic evaluation of zolpidem and its metabolites.

The Effects of Castration on the Pharmacokinetics of Zolpidem After Single Dose Administration In Men With Prostate Cancer Undergoing Androgen Deprivation Therapy Compared to Normal Healthy Females

A Pilot Study to Evaluate the Effects of Castration on the Pharmacokinetics of Zolpidem After Single Dose Administration in Men With Prostate Cancer Undergoing Androgen Deprivation Therapy Compared to Normal Healthy Females

.All IPD recorded in the medical record will be shared with intramural investigators upon request.

The AUC values will be compared between the time points for males to see if the AUC increases significantly.

Assess whether AUC values are approximately equivalent between post-ADT males and healthy females.

National Cancer Institute (NCI)

Symptoms and General Pathology

Endometrial Neoplasms

Pain

Uterine Neoplasms

Genital Neoplasms, Female

Uterine Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Participants randomized to the zolpidem (intervention) group will receive the FDA approved dose of zolpidem, (10 mg for women \<65; 5 mg for women \> or = 65 years). For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute. During their presurgery visit (visit 1), participants will be provided with their capsule and instructed to take it by mouth immediately before bedtime the night before surgery.

Participants randomized to the sugar pill (control) group will receive placebo. For the purposes of this double-blind trial, placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute. During their presurgery visit (visit 1), participants will be provided with their capsule and instructed to take it by mouth immediately before bedtime the night before surgery.

Participants will receive the FDA approved dose of zolpidem, (10 mg for women \<65; 5 mg for women = or \> 65 years) during their presurgery visit and will be instructed to take the single capsule by mouth immediately before bedtime the night before surgery.

zolpidem

Participants will receive placebo (sugar) pills during their presurgery visit and will be instructed to take the single capsule by mouth immediately before bedtime the night before surgery.

sugar pill

Dana H Bovbjerg, PhD

This study proposes to test the hypothesis that zolpidem taken the night before major surgery for endometrial cancer will improve sleep efficiency and reduce post surgery pain, as well as reduce the need for analgesic medication.

Despite continuing improvements in surgical procedures and ancillary care, post surgery pain continues to be a nearly universal patient experience following major operative procedures. Opioids provide considerable pain relief, but they have multiple adverse side effects and are not entirely effective. For cancer patients, uncontrolled postoperative pain can have a substantial negative effect on quality of life, can slow recovery, increase the likelihood of complications, and contribute to poorer postoperative outcomes. The identification of novel modifiable patient risk factors for post surgery pain that could become the target of presurgery interventions is thus an important goal. We will conduct a randomized, placebo-controlled, double-blind intervention trial design to evaluate the effects of an FDA approved hypnotic (zolpidem) on post surgery pain. Since presurgery psychological factors (e.g., heightened anxiety) are known to predict the severity of post surgical pain and may be associated with poor sleep, we will also assess psychological factors (with questionnaires) as well as sleep (using actigraphy) in order to determine their individual and combined impact on women's experiences of post surgery pain in this stressful clinical context. Aim 1: To determine the impact of zolpidem administered the night prior to endometrial cancer surgery on women's experiences of pain over the initial 7-10 day follow-up period after surgery using a double-blind placebo-controlled design (final n=128). Aim 2: To investigate psychological factors on the morning before surgery, as well as objective sleep variables on the night before surgery, as possible mediators of the beneficial effects of zolpidem on post surgery pain. Aim 3: To examine psychological factors, as well as sleep variables, assessed prior to the sleep intervention as possible moderators of the ameliorative effects of zolpidem on post surgery pain. The results of the proposed exploratory study would provide the preliminary data necessary for an R01 application to support more comprehensive investigations, including explorations of biological mechanisms underlying the preventative effects of better presurgery sleep on patients' experiences of post surgery pain.

Sleep and Endometrial Cancer

Surgery for Endometrial Cancer: Biobehavioral Analysis of Sleep, Stress and Pain

Pain intensity and pain interference subscales from the Brief Pain Inventory (Short-form) (BPI) will be used to measure pain over the interval following surgery. Both subscales have a range of 0-10 with higher scores indicating worse outcomes (more intense pain and more pain interference).

Pain severity will be assessed daily following surgery with a visual analogue scale (VAS) completed by participants each night before they go to bed (daily diary PM). VAS pain severity yields a score of 0 to 100, with 100 indicating pain "as bad as it could be."

Analgesic medication consumption will be calculated (morphine equivalent daily dose (MEDD)) on a daily basis using data down loaded from the patient-controlled analgesia (PCA) pump supplemented by information from clinical charts and patient self report on the daily diary form. MEDD starts at zero and does not have an upper limit; higher daily doses indicate more analgesic medication consumption, and thus more pain.

University of Pittsburgh

Professor

Participants randomized to the Intervention group will receive the FDA approved dose of zolpidem, (10 mg for women \<65; 5 mg for women \> or = 65 years). For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.

Participants in the Control group will receive placebo. For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.

Sugar Pill

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Due to limited enrollment in this study, and the small amount of data collected, we are unable to produce any significant results or conclusions.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Effects of Castration on the Pharmacokinetics of Zolpidem After Single Dose Administration In Men With Prostate Cancer Undergoing Androgen Deprivation Therapy Compared to Normal Healthy Females	NCT03436745	Prostatic Neopl...	Zolpidem	18 Years -	National Institutes of Health Clinical Center (CC)
Sleep and Endometrial Cancer	NCT00936598	Sleep Endometrial Neo... Pain	zolpidem sugar pill	18 Years -	University of Pittsburgh
Sleep and Endometrial Cancer	NCT00936598	Sleep Endometrial Neo... Pain	zolpidem sugar pill	18 Years -	University of Pittsburgh

Spots Global Cancer Trial Database for zolpidem

Every month we try and update this database with for zolpidem cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for zolpidem

Every month we try and update this database with for zolpidem cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for zolpidem cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.