A study to evaluate how cytisinicline works in patients with nicotine addiction and kidney problems or those undergoing dialysis

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What is this study about?

This study focuses on individuals with nicotine addiction, a condition characterized by a physical and psychological dependence on nicotine. The research involves the use of a medication called cytisinicline, which is administered as a 3 mg oral film coated tablet. The purpose of the study is to investigate how renal impairment, which refers to a decreased ability of the kidneys to filter waste from the blood, and dialysis, a medical process that cleans the blood when kidneys cannot function properly, affect how the body processes this drug.

During the study, the way the body absorbs, distributes, and removes the medication will be examined. This process is known as pharmacokinetics. Researchers will look at how much of the drug remains in the blood and how much is removed through urine or during the blood cleaning process. The study will also monitor safety by observing vital signs and conducting various clinical tests.

Who Can Join the Study?

You must provide written informed consent, which means signing a document that explains everything about the study before any tests begin.
If you have ESRD (End-Stage Renal Disease, a condition where the kidneys no longer work well enough to sustain life), you must have been receiving dialysis (a medical process that cleans your blood when kidneys fail) for at least 3 months.
Your blood pressure (the force of blood against your artery walls) and pulse rate (how many times your heart beats per minute) must fall within specific healthy ranges depending on your age.
Your eGFR (estimated Glomerular Filtration Rate, a measurement used to check how well your kidneys are filtering waste) must fall into specific categories ranging from normal function to ESRD.
Your clinical laboratory tests (blood and urine tests) must show no significant health problems.
You must be able to communicate clearly with the study doctor and follow all study rules.
You must be willing to follow all the procedures and restrictions required by the study.
You must be a male or female between the ages of 18 and 75 years old.
Your BMI (Body Mass Index, a measure of body fat based on your height and weight) must be between 18.0 and 35.0.
Women must either be unable to have children (due to permanent sterilization or being past menopause) or agree to use effective contraception (methods to prevent pregnancy) for a specific period.
You must test negative for HIV (a virus that attacks the immune system), Hepatitis B, and Hepatitis C (viruses that affect the liver).
Any other medicines you are currently taking must be stable, meaning you have been taking the same dose for at least 7 days without changes.

Who Cannot Join the Study?

You have a known allergy or hypersensitivity (an extreme reaction by the immune system) to the study medicine or any of its excipients (inactive ingredients used to make the medicine).
You test positive for drugs-of-abuse (illegal drugs) or ethanol (alcohol) during the initial screening or when joining the study.
You have veins (blood vessels) in both arms that are difficult to use for intravenous puncture (the process of inserting a needle into a vein to give medicine or take blood).
You have participated in any other clinical trial (a research study involving human participants) within the last 2 months.
You have lost 250 mL or more blood (about one cup of blood) within the 3 months before the study starts.
Female participants who test positive for pregnancy through a blood test during screening or a urine test when joining the study.
Female participants who are currently breast-feeding.
You have severe cardiac disease (serious heart problems).
You have a history of severe renal artery stenosis (a narrowing of the arteries that carry blood to the kidneys).
You have unstable diabetes mellitus (a condition where blood sugar levels are not well-controlled).
You have any other systemic disease (a disease that affects the entire body) that is not related to kidney function and could interfere with the study results.
You have a history of receiving a transplant (surgery to replace an organ) of the kidney, heart, or liver.
You have any organ disorder (problems with internal organs) other than kidney issues that might affect how the body processes the study medicine.
You are using any medication (medicine) that might change how the body processes the study drug.
Your clinical laboratory tests (blood, urine, or chemical tests) show important abnormalities, unless they are related to your kidney function.
Your blood hemoglobin (a protein in red blood cells that carries oxygen) is less than 10g/dL.
You have any medical or surgical condition that might affect the absorption (how the drug enters the body), distribution (how it moves through the body), metabolism (how the body breaks it down), or excretion (how the body gets rid of it) of the study treatment.
You have had symptoms of an acute infection (a sudden, severe infection caused by bacteria, viruses, or fungi) in the 4 weeks before the study starts.
You have a history of alcohol use disorder or substance use disorder (addiction to drugs or alcohol) within the 3 years before the study.
Your electrocardiogram (an ECG, which is a test that records the electrical activity of your heart) shows abnormal results.
You are currently taking any creatine supplement (a substance used to improve muscle performance).
You have used nicotine (found in cigarettes, patches, gum, or e-cigarettes) within 48 hours before joining the study.
You consume excessive caffeine (defined as 800 mg or more per day, such as from large amounts of coffee or energy drinks).

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Clinico San Carlos	Madrid	Spain

Other Sites

Site Name	City	Country
Unidade Local De Saude De Gaia/Espinho E.P.E.	Vila Nova De Gaia	Portugal
CCAB Centro Clinico Academico Braga Associacao	Braga	Portugal
Unidade Local De Saude De Matosinhos E.P.E.	Senhora Da Hora	Portugal
Bbxttylzgyih Iuybfybcvxbj E Dcitnpmiixhpphk Ew Sreub Lxhj	Porto	Portugal
Hmiymcxr Uxtigunirwthr Dk Lm Psobysup	Madrid	Spain
Fomsxyolr Pjow Li Iqyyycznegude Btsadtchb Das Hbmhepax Ufyzkjpupdksf Lo Pdy	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Portugal	Not recruiting	04.10.2022
Spain	Not recruiting	04.10.2022

Trial locations

Investigated drugs:

Cytisinicline

Cytisinicline is a medication being studied to see how it moves through and is processed by the body, specifically in people whose kidneys do not work normally or who receive dialysis treatment.

Nicotine addiction – This condition involves a physical and psychological dependence on nicotine, which is a substance found in tobacco products. It typically begins when a person uses nicotine, leading to changes in the brain’s reward system. As the dependence grows, the individual experiences strong cravings and a repetitive urge to consume the substance. Over time, the body becomes accustomed to the presence of nicotine, making it difficult to stop using it without experiencing discomfort. The habit often becomes a regular part of daily routines and behavioral patterns.

Trial ID:

2022-500921-34-00

Protocol code:

ACH-CYT-05

Trial Phase:

Human Pharmacology (Phase I) – Other

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