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Study Summary
This trial tests a new drug in healthy people to see if it is safe and effective.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
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- I have used opioid medications for a long time.I haven't taken any experimental drugs recently.I have a significant mental health condition or a history of suicide attempts.I drink less than the specified alcohol limits.I do not have any major health or mental health issues.I have had a major injury, surgery, or biopsy in the last 4 weeks.I have taken medication for opioid addiction, like methadone or buprenorphine.I have not taken any prohibited medications recently.I agree to use a condom, and my partner will use birth control.I am not pregnant, breastfeeding, or planning to become pregnant during the study.I am between 18 and 55 years old.I expect to need pain medication for upcoming surgery.I am not pregnant and agree to use effective birth control during and after the study.You currently use tobacco or any products that have nicotine, like cigarettes, e-cigarettes, chewing tobacco, or nicotine gum.I have a history of fainting, low blood pressure, or low blood sugar.I agree not to take any opioid painkillers.Your body weight is within a healthy range, neither too low nor too high.I am allergic to certain opioid antagonists or ingredients like benzyl alcohol or sesame oil.
- Group 1: NRS-033: Cohorts 1-3
- Group 2: Placebo: Cohorts 1-3
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does this research project encompass those above the age of 45?
"In accordance with the criteria for participation, the lower age limit is 18 and upper age limit for enrolment in this trial is 55."
Are there vacancies for participants in this research project?
"According to clinicaltrials.gov, the posting for this trial is no longer active as of February 10th 2023 and has ceased recruitment efforts. Nevertheless, there are 824 other medical studies looking for participants currently."
Has the FDA endorsed NRS-033: Cohorts 1-3?
"Our team's review gave NRS-033: Cohorts 1-3 a score of 1 due to the limited safety and efficacy data available from this Phase 1 clinical trial."
Am I eligible to enroll in this investigation?
"This clinical study requires 24 participants between 18 and 55 who are in good health. Other prerequisites include a body mass index of 18-35 kg/m2, no clinically significant abnormal vital signs on screening, negative pregnancy tests for female subjects, agreement to not take opioid analgesics, and adherence to NIAAA's low risk drinking criteria (3 drinks per day or 7 drinks per week for women; 4 drinks per day or 14 drinks per week for men). Additionally, male patients with female partners of childbearing potential must use condoms while the female partner uses highly effective contraception methods."
Who else is applying?
What state do they live in?
What portion of applicants met pre-screening criteria?
What site did they apply to?
How many prior treatments have patients received?
What questions have other patients asked about this trial?
Why did patients apply to this trial?
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