Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

CSD170202: A Study to Evaluate the Exposure to Tobacco Constituents From Two Moist Snuff Products

7. september 2017 opdateret af: RAI Services Company

CSD170202: A Crossover Study to Evaluate the Exposure to Tobacco Constituents From Two Moist Snuff Products

This study will evaluate exposure to tobacco constituents from two moist snuff products, and provide a basis for comparing mouth-level exposure (MLE) in moist snuff users after use of each of the two moist snuff products.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

This will be an unblinded, single-center, randomized, two-way crossover study, conducted in generally healthy, adult moist snuff users who will be randomly assigned to the order in which they will use two moist snuff study products (comparator product, test product). Enrolled subjects will use one of each of the study products exclusively for approximately one week (seven days +1/-2 day) prior to a test visit, with a different product used each week over a two-week period. During each test visit, subjects will use study product ad libitum during a 6-hour period. Expectoration will be collected from the subjects during each product use. The used study product will be collected after use. Blood samples will be collected at each test visit, prior to study product use, for determination of plasma cotinine levels.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

55

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Georgia
      • Stockbridge, Georgia, Forenede Stater, 30281
        • Clinical Research Atlanta

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

21 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Able to read, understand, and willing to sign an Informed Consent Form (ICF) written in English;
  2. Generally healthy males and females, 21 years of age or older, at Screening-Enrollment Visit;
  3. Self-reports currently using at least two cans of moist snuff per week;
  4. Self-reports that moist snuff is the only tobacco- or nicotine-containing product used within 30 days of the Screening-Enrollment Visit;
  5. Usual brand (UB) of moist snuff is one of the products specified in the protocol;
  6. Used their UB product for ≥ 3 months;
  7. Subject is not delaying a decision to quit using moist snuff to participate in the study;
  8. Agrees to exclusively use the study products and not use any other tobacco- or nicotine-containing products during the course of the study;
  9. Able to safely perform the required study procedures, as determined by the Investigator.

Exclusion Criteria:

  1. Self-reported history of heart disease, kidney disease, diabetes, liver disease, uncontrolled hypertension, or uncontrolled hypercholesterolemia;
  2. At risk for heart disease, i.e., obesity (body mass index [BMI] > 43 kg/m2), as determined by the Investigator;
  3. Females ≥ 35 years of age currently using systemic, estrogen-containing contraception, or hormone replacement therapy;
  4. Use of any medication or substance that aids in smoking cessation, including but not limited to any nicotine replacement therapy (NRT) (e.g., nicotine gum, lozenge, patch), varenicline (Chantix®), bupropion (Wellbutrin®, Zyban®), or lobelia extract within 30 days prior to the Screening-Enrollment Visit;
  5. Females who are pregnant or breastfeeding, or plan to become pregnant during the course of the study;
  6. Participation in another clinical study within 30 days prior to the Screening-Enrollment Visit. (The 30-day window for each subject will be derived from the date of the last study event in the previous study to the Screening-Enrollment Visit of the current study);
  7. Determined by the Investigator to be ineligible for the study.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: CSD170202AA, CSD170202AB Use Group
Use of product CSD170202AA exclusively for approximately one week (seven days +1/-2 day) prior to a test visit, followed by use of product CSD170202AB exclusively for approximately one week (seven days +1/-2 day) prior to a test visit.
A moist snuff product
A moist snuff product
Eksperimentel: CSD170202AB, CSD170202AA Use Group
Use of product CSD170202AB exclusively for approximately one week (seven days +1/-2 day) prior to a test visit, followed by use of product CSD170202AA exclusively for approximately one week (seven days +1/-2 day) prior to a test visit.
A moist snuff product
A moist snuff product

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Mundniveaueksponering (MLE) af nikotin pr. gram (eller produkt)
Tidsramme: 6 timer
6 timer

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Samarbejdspartnere

Efterforskere

  • Ledende efterforsker: Nathan Segall, MD, Clinical Research Atlanta

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

8. maj 2017

Primær færdiggørelse (Faktiske)

25. juli 2017

Studieafslutning (Faktiske)

25. juli 2017

Datoer for studieregistrering

Først indsendt

16. maj 2017

Først indsendt, der opfyldte QC-kriterier

16. maj 2017

Først opslået (Faktiske)

18. maj 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. september 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. september 2017

Sidst verificeret

1. september 2017

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • CSD170202

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner