Effects of Cigar Flavors on Measures of Abuse Liability Among Young Adults
22 aprile 2019 aggiornato da: 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:
- own-brand CTC (positive control),
- original-flavored Black & Mild (B&M) cigar,
- apple-flavored B&M cigar,
- cream-flavored B&M cigar, and
- wine-flavored B&M cigar.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
25
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
Virginia
-
Richmond, Virginia, Stati Uniti, 23284
- VCU Behavioral Health Research Laboratory
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 21 anni (Adulto)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: Own Brand Cigarette Condition
|
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
|
|
Sperimentale: Original-flavor Black&Mild cigar
|
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
|
|
Sperimentale: Apple-flavor Black&Mild cigar
|
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
|
|
Sperimentale: Cream-flavor Black&Mild cigar
|
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
|
|
Sperimentale: Wine-flavor Black&Mild cigar
|
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
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in saliva nicotine concentration
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Expired air carbon monoxide
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Andrew J Barnes, PhD, Virginia Commonwealth University
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 ottobre 2016
Completamento primario (Effettivo)
12 aprile 2019
Completamento dello studio (Effettivo)
12 aprile 2019
Date di iscrizione allo studio
Primo inviato
6 settembre 2016
Primo inviato che soddisfa i criteri di controllo qualità
17 ottobre 2016
Primo Inserito (Stima)
18 ottobre 2016
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
23 aprile 2019
Ultimo aggiornamento inviato che soddisfa i criteri QC
22 aprile 2019
Ultimo verificato
1 aprile 2019
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- HM20007848
- R03DA043005 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
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.
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .