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Sedative-Hypnotic

Zolpidem Pharmacokinetics in Prostate Cancer Patients Undergoing Androgen Deprivation Therapy

Phase 1
Recruiting
Led By William D Figg, Pharm.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must not have other concurrent malignancies (within the past 2 years with the exception of non-melanoma skin cancer and Rai Stage 0 chronic lymphocytic leukemia), in situ carcinoma of any site, or life threatening illnesses, including untreated infection (must be at least 1 week off intravenous antibiotic therapy before beginning zolpidem).
For Normal Healthy Female Cohort: Females age greater than or equal to 18 years of age, Good health conditions or without significant diseases, according to best medical judgement., If breastfeeding, must be willing to discard breastmilk for 24 hours following zolpidem., Ability if subject to understand and the willingness to sign a written informed consent Ability to swallow study medication.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial will study how the drug zolpidem affects women and men differently. Men with prostate cancer and women will take the drug and researchers will measure how much of the drug is in their system.

Who is the study for?
Men over 18 with prostate cancer planning to undergo androgen deprivation therapy, and healthy women over 18 can join. Participants must have normal organ function, not be on certain medications or have other cancers, serious illnesses, or psychiatric conditions that could affect the study.Check my eligibility
What is being tested?
The trial is testing how castration affects the levels of Zolpidem in men with prostate cancer compared to its levels in healthy women. Men will take Zolpidem before and after their testosterone-lowering treatment; both groups will stay overnight for monitoring.See study design
What are the potential side effects?
Zolpidem may cause drowsiness, dizziness, headache, gastrointestinal issues like nausea or diarrhea, allergic reactions, daytime drowsiness affecting alertness and coordination (increasing fall risk), and sometimes memory loss.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I haven't had any other cancers except for non-dangerous skin cancer or very early stage leukemia in the last 2 years.
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I am a healthy woman over 18, can take pills, and agree to not breastfeed for 24 hours after taking zolpidem.
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I am a man with confirmed or clinically consistent prostate cancer.
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I am a man aged 18 or older.
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I am fully active or can carry out light work.
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My prostate cancer is getting worse, shown by rising PSA levels or scans.
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I can swallow pills.
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My blood tests show normal organ function and healthy blood cell counts.
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I am planning to undergo hormone therapy for my cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Difference in AUC values in males between pre-ADT and post-ADT
Secondary outcome measures
Comparison of AUC values between post-ADT males and healthy female subjects

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Zolpidem pre and post castrationExperimental Treatment1 Intervention
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
Group II: FemaleActive Control1 Intervention
Single 5 mg oral dose of zolpidem
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zolpidem
2003
Completed Phase 4
~2530

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,627 Previous Clinical Trials
40,927,361 Total Patients Enrolled
561 Trials studying Prostate Cancer
507,171 Patients Enrolled for Prostate Cancer
William D Figg, Pharm.D.Principal InvestigatorNational Cancer Institute (NCI)
10 Previous Clinical Trials
7,089 Total Patients Enrolled
5 Trials studying Prostate Cancer
5,164 Patients Enrolled for Prostate Cancer

Media Library

Zolpidem (Sedative-Hypnotic) Clinical Trial Eligibility Overview. Trial Name: NCT03436745 — Phase 1
Prostate Cancer Research Study Groups: Female, Zolpidem pre and post castration
Prostate Cancer Clinical Trial 2023: Zolpidem Highlights & Side Effects. Trial Name: NCT03436745 — Phase 1
Zolpidem (Sedative-Hypnotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03436745 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you provide me with a summary of past research regarding Zolpidem?

"Presently, 7 clinical trials are studying Zolpidem with none of them being in Phase 3. While most studies take place at Silver Spring, Maryland, 16 other sites across the United States are also conducting research on this medication."

Answered by AI

Is Zolpidem a viable option for individuals seeking safer treatment?

"The safety of Zolpidem was appraised as a 1 due to the Phase 1 trial status; there is only minimal data currently available on its efficacy and security."

Answered by AI

How many participants are included in this research endeavor?

"Affirmative. Clinicaltrials.gov highlights that this medical experiment is actively recruiting participants, having first been posted on January 22nd 2019 and most recently updated on November 22nd 2022. This trial necessitates the recruitment of 30 individuals from a singular site."

Answered by AI

Is enrollment for this clinical trial available at this time?

"Information on clinicaltrials.gov indicates that this medical research is actively recruiting individuals for evaluation. This trial was initially made available to the public in January of 2019, with its most recent update taking place in November of 2022."

Answered by AI
~3 spots leftby Dec 2024