- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01568905
Palatability of Experimental Cigarettes - Study 2
30. oktober 2019 oppdatert av: University of Minnesota
Palatability of Experimental Cigarettes
Smoking remains a leading cause of preventable disease and premature death worldwide.
Approximately 1 out of every 5 deaths is associated with cigarette smoking, and roughly half of all daily smokers will die prematurely from tobacco-related illness.
Reducing the nicotine in cigarettes to the point that they are rendered non-addictive can potentially be an effective public policy measure that can significantly reduce tobacco-related mortality and morbidity by decreasing the initiation of smoking and promoting cessation.
The Family Smoking Prevention and Tobacco Control Act (FSPTCA) enables the FDA to establish tobacco product standards including placing limits on the allowable nicotine content of cigarettes.
Currently, no reduced nicotine cigarettes are available that will allow studying the feasibility of this policy measure.
The National Institute on Drug Abuse has contracted with Research Triangle Institute to assist in the development of cigarettes with varying nicotine content that can be made available to researchers.
They have established a contract that will result in the manufacture of 9 million cigarettes to be distributed to the research community.
Prior to full production, the palatability and nicotine intake of these cigarettes in smokers must be determined.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
Phase 3: This descriptive study will use a between subjects, double blind design.
This study will test 3 nicotine levels of nicotine, tar and ventilation.
Subjects and research assistants will be blind to the cigarette type.
Studietype
Intervensjonell
Registrering (Faktiske)
36
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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Minnesota
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Minneapolis, Minnesota, Forente stater, 55414
- University of Minnesota
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 64 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- 18-64 years old
- Regular smokers (10+ cigarettes per day and has done so for the last year)
- Inhaling when smoking
- Carbon monoxide (CO) > 8 ppm
Exclusion Criteria:
- In the past year, suffered from any cardiovascular disease such as: heart disease, heart attack, stroke or angina, any respiratory diseases such as chronic bronchitis or chronic obstructive pulmonary disease (COPD), any type of cancer
- Currently suffering from Bipolar Disorder, General Anxiety Disorder, Schizophrenia, or a major depressive episode
- Taken any of the following drugs more than twice per week during the past month: antidepressants, anti-anxiety medications.
- Consumed more than 15 alcoholic drinks per week for the past month
- Pregnant, trying to become pregnant, or lactating (assessed by self-report)
- In the past 3 months, used nicotine replacement products (like the patch, gum, or inhaler), or the medications bupropion varenicline
- Currently trying or planning to reduce or quit tobacco use in the next 30 days
- Used other forms of tobacco 10 or more days in the past 30 days
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Arm 1 Low Level Nicotine Cigarette
(0.4 mg/g)
|
smoke the study cigarette exclusively for one week
|
|
Eksperimentell: Arm 2 Intermediate Nicotine Level Cigarette
(5.7-5.8 mg/g)
|
smoke the study cigarette exclusively for one week
|
|
Eksperimentell: Arm 3 High Level Nicotine Cigarette
(11.4-12.8 mg/g)
|
smoke the study cigarette exclusively for one week
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in UrineTotal Nicotine Equivalent (TNE) Between Baseline and Week 1
Tidsramme: Second Visit (Week 1) minus Baseline (Day 1)
|
Two urine TNE levels are taken, one at baseline and one at week 1, to assess TNE levels for nicotine exposure.
TNE is the sum of nicotine, cotinine, trans 3'-hydroxycotinine and their respective glucuronide conjugates.
Values reported in nmols/ml.
|
Second Visit (Week 1) minus Baseline (Day 1)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Responses on Modified Cigarette Evaluation Scale
Tidsramme: Baseline usual brand cigarettes (Day 1) compared to when using study cigarettes (Week 1)
|
Modified Cigarette Evaluation Scale [CES] is a 100 mm visual analog scale (0=not at all or very little nicotine; 100=extremely or high in nicotine) of 20 questions assessing different dimensions of responses to usual brand cigarettes (e.g., psychological reward, satisfaction and aversiveness) and includes additional 5 point likert-type questions (definitely agree to definitely disagree) on perceptions of satisfaction and willingness to use the product.
Results satisfaction subscale.
|
Baseline usual brand cigarettes (Day 1) compared to when using study cigarettes (Week 1)
|
|
Change From Baseline of Perceived Health Risk Scale Response to Test Cigarettes
Tidsramme: Baseline (Day 1) Compared to Second Visit (Week 1)
|
Questionnaire: Perceived Health Risk Scale asks subjects to rate their perception of health risks for lung cancer for the study product to which they have been randomly assigned.
This is a 100 mm visual analog scale; 0=very low risk of disease, 100=very high risk of disease.
|
Baseline (Day 1) Compared to Second Visit (Week 1)
|
|
Comparison of Number of Cigarettes Smoked
Tidsramme: 1 week
|
Subjects were given a daily diary to collect the number of study and/or conventional cigarettes they have smoked each day.
Cigarettes smoked (both usual brand and experimental) in a given week were summed over the first 7 reported days.
If the number of cigarettes smoked was missing for 1 day, the average of the other days in that week was used in its place and reported as total number of cigarettes per week.
|
1 week
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Dorothy Hatsukami, Ph.D., Tobacco Use Research Program, University of Minnesota
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. februar 2011
Primær fullføring (Faktiske)
1. mars 2012
Studiet fullført (Faktiske)
1. mars 2012
Datoer for studieregistrering
Først innsendt
3. januar 2012
Først innsendt som oppfylte QC-kriteriene
29. mars 2012
Først lagt ut (Anslag)
2. april 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
1. november 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
30. oktober 2019
Sist bekreftet
1. oktober 2019
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1012M94314
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .