Methods Project 4: Clinical Trial - Amended (COMET)
Project 4: Clinical Trial Method for Assessing a Tobacco Product Part of Models for Tobacco Product Evaluation:
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Sampling period (1 week): Subjects will be randomized to an alternative nicotine product (E-cigarette, Nicotine Gum or Lozenge) or assigned to continue smoking their usual brand cigarettes. Subjects will complete screening assessments, asked to sample the assigned product and start recording their cigarette or other tobacco intake on a daily basis using an interactive voice response system (IVR). Smokers assigned to the control condition (smoking usual brand cigarettes) will be asked to choose the product that they would like to sample.
Baseline smoking period: After sampling, subjects who meet specific criteria will continue with the experimental intervention phase. These subjects will be required to attend 2 baseline clinic visits where baseline assessments will be captured. Records of their cigarette or other tobacco intake on a daily basis will continue using the interactive voice response system (IVR).
Experimental Period: After the baseline assessment, subjects will be instructed to either partially or completely substitute their cigarette smoking with their assigned product. They will assigned to one of six experimental conditions:
- smoking usual brand cigarette controls, who after 8-weeks will be offered any of the other nicotine products to use as they choose for 8 weeks;
- complete substitution (i.e., no smoking) with an E-cigarette;
- partial substitution with an E-cigarette;
- complete substitution (i.e., no smoking) with nicotine gum or nicotine lozenge.
The assigned product, E-cigarette, Nic Gum or Lozenge, but not usual brand cigarettes, will be provided to subjects at the clinic visits. Subjects will attend clinic visits over the next 8 weeks where tobacco use patterns and biomarker data will be collected.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Minnesota
-
Minneapolis, Minnesota, Förenta staterna, 55455
- Masonic Cancer Center, University of Minnesota
-
-
New York
-
Buffalo, New York, Förenta staterna, 14263
- Roswell Park Cancer Center
-
-
Ohio
-
Columbus, Ohio, Förenta staterna, 43210
- Ohio State University Comprehensive Cancer Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Male or female subjects who are at least 18 years of age;
- Daily smoker;
- Generally good health;
- Subject has provided written informed consent to participate in the study (adolescents under the age of 18 will be excluded because this project involves continued use of tobacco products and new tobacco products);
Exclusion Criteria:
- Unstable health;
- Pregnant or breastfeeding (due to toxic effects from tobacco products);
- Unable to read for comprehension or completion of study documents.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Usual Brand Cigarette
Smoking usual brand cigarette controls, who after 8-weeks will be offered alternative nicotine products and instructed for partial or complete substitution of cigarettes (subject's choice);
|
Rök deras vanliga märke av cigaretter och följ deras normala användningsmönster.
|
|
Experimentell: Complete Substitution E-Cigarette
Complete substitution (i.e., no smoking) with e-cigarette use
|
Use of E-cigarette: multiple flavors offered.
|
|
Experimentell: Partial Substitution E-Cigarette
Partial substitution, encouraged to use e-cigarettes instead of smoking usual cigarettes
|
Rök deras vanliga märke av cigaretter och följ deras normala användningsmönster.
Use of E-cigarette: multiple flavors offered.
|
|
Experimentell: Complete Substitution Nic Gum or Lozenge
Complete substitution (i.e., no smoking) to nicotine gum or lozenge use
|
Subject choice: Use of nicotine gum or nicotine lozenge, multiple flavors offered
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Compare total nicotine equivalents (TNE) based on differing instructions for oral tobacco, nicotine replacement or e-cigarette use.
Tidsram: 6 months
|
Compare the exposure to nicotine in the two instructions for use arms (complete substitution vs. partial substitution) across study products and compared to medicinal nicotine products and usual brand cigarettes.
|
6 months
|
|
Determine stabilization of product use (e.g., cigarette, oral tobacco, e-cigarette or medicinal nicotine patterns of use).
Tidsram: 6 months
|
Examining time effects for patterns of use of cigarettes, nicotine replacement, oral tobacco or e-cigarette.
|
6 months
|
|
Consumer perception of the product and response to the product after sampling.
Tidsram: 6 months
|
Consumer perception of the product evidenced by choice of which product to use in the trial after sampling.
|
6 months
|
|
Compare NNK exposure based on differing instructions for oral tobacco, nicotine replacement or e-cigarette use.
Tidsram: 8 weeks
|
Complete substitution vs. partial substitution of study products for cigarettes and compare the exposure to NNK by analyzing NNAL levels in subject urine.
These products are compared to medicinal nicotine products and usual brand cigarettes.
|
8 weeks
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2012NTLS050b
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 .
Kliniska prövningar på Tobaksrökning
-
Eunice Kennedy Shriver National Institute of Child...AvslutadEnvironmental Tobacco Smoke (ETS)Förenta staterna