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Effects of Cigar Flavors on Measures of Abuse Liability Among Young Adults

22. april 2019 opdateret af: Virginia Commonwealth University

This study involves 25 current young adult combustible tobacco cigarette (CTC) smokers who will complete 5 Latin square ordered, within-subject, laboratory conditions that differ by the tobacco product smoked:

  1. own-brand CTC (positive control),
  2. original-flavored Black & Mild (B&M) cigar,
  3. apple-flavored B&M cigar,
  4. cream-flavored B&M cigar, and
  5. wine-flavored B&M cigar.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

25

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Virginia
      • Richmond, Virginia, Forenede Stater, 23284
        • VCU Behavioral Health Research Laboratory

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

18 år til 21 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • To be included, participants must be healthy, as determined by self-report and heart rate/blood pressure (HR/BP) check, between the ages of 18-25, and willing to provide informed consent.
  • They must agree to attend the lab and abstain from tobacco/nicotine as required, to use the designated products, and to follow the study protocol.
  • Participants must also be regular CTC smokers (≥5 cigarettes/day for past 3 months) naïve to cigar products (smoked no more than 10 cigar products of any type in lifetime) who can provide a semi-quantitative urine cotinine result of ≥3 at screening (NicAlert test).

Exclusion Criteria:

  • Individuals with a self-reported history of chronic diseases or psychiatric conditions will be excluded.
  • Other exclusion criteria are: history of or active cardiovascular disease, current oral health problems or injuries, low/high BP, seizures, regular prescription medication use (other than vitamins or birth control), and past month use of cocaine, opioids, benzodiazepines, and methamphetamine (self-report).
  • Individuals who report using marijuana or alcohol >20 days in the past 30 or interest in quitting CTC use within the next 30 days will also be excluded.
  • Women will be excluded if they are breast-feeding or test positive for pregnancy (by urinalysis) at screening.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Own Brand Cigarette Condition
Andet: Tobacco product administration and assessment
two bouts of 10 puffs of a tobacco product with a 30-second interpuff interval separated by 60 minutes; preceded and followed by physiological, subjective and topography assessment
Eksperimentel: Original-flavor Black&Mild cigar
Andet: Tobacco product administration and assessment
two bouts of 10 puffs of a tobacco product with a 30-second interpuff interval separated by 60 minutes; preceded and followed by physiological, subjective and topography assessment
Eksperimentel: Apple-flavor Black&Mild cigar
Andet: Tobacco product administration and assessment
two bouts of 10 puffs of a tobacco product with a 30-second interpuff interval separated by 60 minutes; preceded and followed by physiological, subjective and topography assessment
Eksperimentel: Cream-flavor Black&Mild cigar
Andet: Tobacco product administration and assessment
two bouts of 10 puffs of a tobacco product with a 30-second interpuff interval separated by 60 minutes; preceded and followed by physiological, subjective and topography assessment
Eksperimentel: Wine-flavor Black&Mild cigar
Andet: Tobacco product administration and assessment
two bouts of 10 puffs of a tobacco product with a 30-second interpuff interval separated by 60 minutes; preceded and followed by physiological, subjective and topography assessment

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in saliva nicotine concentration
Tidsramme: Saliva will be collected at baseline before the first product administration, at 10 min following each product administration, and 55 min following the first product administration (baseline for the second product administration).
Each participant will attend 5 study sessions, each study session will include two bouts of product administration. Product administration will consist of 10 puffs with a 30-second interpuff interval (IPI; puff number and IPI will be directed and monitored by staff).
Saliva will be collected at baseline before the first product administration, at 10 min following each product administration, and 55 min following the first product administration (baseline for the second product administration).
Change in breakpoint from two behavioral choice tasks (Cigarette Purchase Task, Multiple Choice Procedure)
Tidsramme: A behavioral choice task (cigarette purchase cask) will be completed at baseline before the first product administration, 5, 15, 30, and 45 min following each bout. 45 min after the second bout, the multiple choice procedure will be administered.
Each participant will attend 5 study sessions, each study session will include two bouts of product administration. Product administration will consist of 10 puffs with a 30-second interpuff interval (IPI; puff number and IPI will be directed and monitored by staff).
A behavioral choice task (cigarette purchase cask) will be completed at baseline before the first product administration, 5, 15, 30, and 45 min following each bout. 45 min after the second bout, the multiple choice procedure will be administered.
Change in Addiction Research Center Inventory subjective abuse liability
Tidsramme: Subjective measures of abuse liability will be collected at baseline before the first product administration, 5, 15, 30, and 45 min following each bout.
Each participant will attend 5 study sessions, each study session will include two bouts of product administration. Product administration will consist of 10 puffs with a 30-second interpuff interval (IPI; puff number and IPI will be directed and monitored by staff).
Subjective measures of abuse liability will be collected at baseline before the first product administration, 5, 15, 30, and 45 min following each bout.
Change in Direct Effects of Nicotine and Tobacco Scale subjective abuse liability
Tidsramme: Subjective measures of abuse liability will be collected at baseline before the first product administration, 5, 15, 30, and 45 min following each bout.
Each participant will attend 5 study sessions, each study session will include two bouts of product administration. Product administration will consist of 10 puffs with a 30-second interpuff interval (IPI; puff number and IPI will be directed and monitored by staff).
Subjective measures of abuse liability will be collected at baseline before the first product administration, 5, 15, 30, and 45 min following each bout.
Change in Tobacco Abstinence Symptoms and Drug Effects subjective abuse liability
Tidsramme: Subjective measures of abuse liability will be collected at baseline before the first product administration, 5, 15, 30, and 45 min following each bout.
Each participant will attend 5 study sessions, each study session will include two bouts of product administration. Product administration will consist of 10 puffs with a 30-second interpuff interval (IPI; puff number and IPI will be directed and monitored by staff).
Subjective measures of abuse liability will be collected at baseline before the first product administration, 5, 15, 30, and 45 min following each bout.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Expired air carbon monoxide
Tidsramme: Expired air carbon monoxide measurement will occur at baseline before the first product administration, 15 minutes following each bout, 55 min following the first product administration (baseline for the second product administration).
Each participant will attend 5 study sessions, each study session will include two bouts of product administration. Product administration will consist of 10 puffs with a 30-second interpuff interval (IPI; puff number and IPI will be directed and monitored by staff).
Expired air carbon monoxide measurement will occur at baseline before the first product administration, 15 minutes following each bout, 55 min following the first product administration (baseline for the second product administration).
Heart rate
Tidsramme: Heart rate will be recorded at one second intervals from session onset (minute zero of session) through minute 155 of the session (end of session).
Each participant will attend 5 study sessions, each study session will include two bouts of product administration.Product administration will consist of 10 puffs with a 30-second interpuff interval (IPI; puff number and IPI will be directed and monitored by staff).
Heart rate will be recorded at one second intervals from session onset (minute zero of session) through minute 155 of the session (end of session).
Blood pressure
Tidsramme: Blood pressure will be recorded at 5 minute intervals from from session onset (minute zero of session) through minute 155 of the session (end of session).
Each participant will attend 5 study sessions, each study session will include two bouts of product administration.Product administration will consist of 10 puffs with a 30-second interpuff interval (IPI; puff number and IPI will be directed and monitored by staff).
Blood pressure will be recorded at 5 minute intervals from from session onset (minute zero of session) through minute 155 of the session (end of session).
Puff Volume (ml)
Tidsramme: Puff Volume will be measured in seconds for each puff during product administration (10 puffs with a 30-second interpuff interval directed and monitored by staff)
The instrument senses flow-induced pressure drop across an orifice that is incorporated into the mouthpiece. Each participant will attend 5 study sessions, each study session will include two bouts of product administration. Puff Volume and Puff Duration will be used to calculate measures of Puff Flow Rate (Puff Volume/Puff Duration) and Total Puff Volume (Puff Volume per puff x 10 puffs).
Puff Volume will be measured in seconds for each puff during product administration (10 puffs with a 30-second interpuff interval directed and monitored by staff)
Puff Duration (seconds)
Tidsramme: Puff Duration will be measured in seconds for each puff during product administration (10 puffs with a 30-second interpuff interval directed and monitored by staff)
The instrument senses flow-induced pressure drop across an orifice that is incorporated into the mouthpiece. Each participant will attend 5 study sessions, each study session will include two bouts of product administration. Puff Volume and Puff Duration will be used to calculate measures of Puff Flow Rate (Puff Volume/Puff Duration) and Total Puff Volume (Puff Volume per puff x 10 puffs).
Puff Duration will be measured in seconds for each puff during product administration (10 puffs with a 30-second interpuff interval directed and monitored by staff)

Samarbejdspartnere og efterforskere

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

Sponsor

Virginia Commonwealth University

Samarbejdspartnere

National Institute on Drug Abuse (NIDA)

Efterforskere

  • Ledende efterforsker: Andrew J Barnes, PhD, Virginia Commonwealth University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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)

1. oktober 2016

Primær færdiggørelse (Faktiske)

12. april 2019

Studieafslutning (Faktiske)

12. april 2019

Datoer for studieregistrering

Først indsendt

6. september 2016

Først indsendt, der opfyldte QC-kriterier

17. oktober 2016

Først opslået (Skøn)

18. oktober 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. april 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. april 2019

Sidst verificeret

1. april 2019

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • HM20007848
  • R03DA043005 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Once appropriate, a completely de-identified data set will be created that obfuscates any variable that might potentially be used to identify an individual study participant. In accordance with HIPAA definitions for public data sharing, the investigators will use standard acceptable processes that include removal of identifiers, translation of dates and ages to delta time values, assignment of random study identifiers, and any other methods acceptable at that time. A data sharing agreement will be required for release of any data. Individuals requesting a copy of study data will need to submit a detailed research plan that includes the purpose of the proposed research, the variables required, the duration of the analysis phase, IRB approval with FWA information, investigator training in human subjects, and other approvals specific to the individual datasets.

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 .

Kliniske forsøg med Tobacco product administration and assessment

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Placeringer

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