Switching to Reduced Oxidant or Nicotine Content Cigarettes in Smokers
Switching to Reduced Nicotine Content Cigarettes or Reduced Reactive Oxygen/Reactive Nitrogen Species Cigarettes in Smokers
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Researchers at Penn State Hershey are seeking healthy adult cigarette smokers between 21-65 who smoke any of the following brands on a regular basis: Marlboro Red, Marlboro Menthol, Pall Mall Red, Pall Mall Menthol, Kool Menthol, Salem Menthol, L&M Menthol, Pyramid Red, Newport Red, Newport Menthol.
If you smoke one of these brand styles on a regular basis you may be eligible to participate in a compensated short term study on health and smoking behavior at Penn State Hershey Medical Center.
Study participation lasts 22 days, with 4 study visits at the Medical Center. Smokers are asked to use their usual brand for one week and then switch to 1 of 3 brands for the remaining two weeks. The three brands participants are randomly assigned to after the first week of participation are either Group 1. reduced nicotine content cigarette (Spectrum Research Cigarettes) or Group 2. reduced oxidant cigarette (American Spirit) or assigned to Group 3. usual brand. Whichever group you are assigned to, you will be asked to smoke only these until the end of the study. All cigarettes following visit 1 will be provided free of charge.
Study overview:
Visit 1/ Duration: 60 minutes Provide a blood and urine sample Complete a 20 minute interview Use a simple, hand held smoking device to smoke all cigarettes for 2 days Collect cigarette butts on 1 day
Visit 2: Randomized Phase /Duration: 20-30 minutes Provide a blood and urine sample Complete a 10 minute interview Use a simple, hand held smoking device to smoke all cigarettes for 2 days Collect cigarette butts on 1 day
Visit 3/ Duration: 20-30 minutes Provide a blood and urine sample Complete a 10 minute interview Use a simple, hand held smoking device to smoke all cigarettes for 2 days Collect cigarette butts on 1 day
Visit 4/ Duration: 20-30 minutes Provide a blood and urine sample Complete a 10 minute interview Sign compensation form
For information on additional tobacco studies being conducted at Penn State Hershey, please call 1-844-207-6392
*This research is being conducted under the investigator John Richie at Penn State Hershey; 500 University Drive Hershey, PA
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Pennsylvania
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Hershey, Pennsylvania, Stati Uniti, 17033
- Penn State Hershey
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Age 21-65
- Smoke 10 cigarettes/day or more for at least one year
- Read and write in English
- Menthol and nonmenthol smokers who use relatively high nicotine and ROS/RNS cigarettes
- Able to understand and provide consent to study procedures
- Plan to live in the local area for the next month
- Women not pregnant or nursing and taking steps to avoid pregnancy
- No quit attempt in the last one months and not planning to quit in the next month
Exclusion Criteria:
- Currently pregnant or nursing
- Unstable or significant medical condition, such as COPD or kidney failure, that is likely to affect biomarker data
- Use of non-cigarette nicotine delivery product in the past week (included cigars, pipes, chew, snus, hookah, e-cig, and marijuana)
- Currently reducing or planning to reduce cigarette consumption in the next month
- Use of smoking cessation medicine in the past 3 months
- History of difficulties providing blood samples: fainting, poor veins, anxiety, etc.
- Uncontrolled serious psychotic illness or substance abuse or inpatient treatment for these in the last 6 months (substance abuse includes weekly, almost daily or daily use of other illegal drugs and prescription drugs that are not being used for medically prescribed purposes or alcohol abuse that would hinder the participant's ability to participate)
- Significant medical condition, i.e. stroke, MI, cancer, in the last month
- Currently using illegal drugs
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Reduced Nicotine Cigarettes
Participants will be randomized to receive low nicotine cigarettes to replace their usual high nicotine brand.
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Human topography data will show if smokers smoke their cigarettes differently from baseline following randomization.
Select biosamples of participants will be used to analyze how biomarkers differ among groups
Altri nomi:
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Sperimentale: Reduced ROS/RNS
Participants will be randomized to receive Reduced Oxidative/Nitrogen Species (ROS/RNS) cigarettes to replace their usual cigarettes.
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Human topography data will show if smokers smoke their cigarettes differently from baseline following randomization.
Select biosamples of participants will be used to analyze how biomarkers differ among groups
Altri nomi:
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Comparatore placebo: Control Group
Participants will be assigned to continue smoking their usual brand of cigarettes.
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Human topography data will show if smokers change the way they smoke due to being in a research study.
Select biosamples of participants will be used to analyze how biomarkers differ among groups
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Smoking Topography
Lasso di tempo: 8 days
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measures of smoking topography include parameters such as puff volume, frequency and intensity as measured using a smoking topography instrument.
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8 days
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Biomarkers of oxidative stress
Lasso di tempo: 4 times over the 22 day study period
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biomarkers of oxidative stress are as followed: glutathionylated and cysteinylated proteins in blood and F2-isoprostanes and 8-hydroxydeoxyguanosine (8-OHdG).
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4 times over the 22 day study period
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: John Richie, Ph.D, Milton S. Hershey Medical Center
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- STUDY00001996
- 5P50DA036107-02 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
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