- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01568905
Palatability of Experimental Cigarettes - Study 2
30 oktober 2019 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
36
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Minnesota
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Minneapolis, Minnesota, Förenta staterna, 55414
- University of Minnesota
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 64 år (Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Arm 1 Low Level Nicotine Cigarette
(0.4 mg/g)
|
smoke the study cigarette exclusively for one week
|
|
Experimentell: Arm 2 Intermediate Nicotine Level Cigarette
(5.7-5.8 mg/g)
|
smoke the study cigarette exclusively for one week
|
|
Experimentell: Arm 3 High Level Nicotine Cigarette
(11.4-12.8 mg/g)
|
smoke the study cigarette exclusively for one week
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in UrineTotal Nicotine Equivalent (TNE) Between Baseline and Week 1
Tidsram: 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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Responses on Modified Cigarette Evaluation Scale
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Dorothy Hatsukami, Ph.D., Tobacco Use Research Program, University of Minnesota
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 februari 2011
Primärt slutförande (Faktisk)
1 mars 2012
Avslutad studie (Faktisk)
1 mars 2012
Studieregistreringsdatum
Först inskickad
3 januari 2012
Först inskickad som uppfyllde QC-kriterierna
29 mars 2012
Första postat (Uppskatta)
2 april 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
1 november 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
30 oktober 2019
Senast verifierad
1 oktober 2019
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 1012M94314
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .