An interventional study of Tobacco product administration and assessment in Tobacco Products, sponsored by Virginia Commonwealth University. Completed at 1 site in United States. Open to participants aged 18 Years to 21 Years. Per ClinicalTrials.gov, last updated 2019-04-23.
Sponsored by Virginia Commonwealth University · Not applicable, Interventional, and Basic science
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:
Virginia Commonwealth University is the lead sponsor of 641 studies on the registry; 82 are open to participants now.
Of its 88 completed or terminated interventional studies of FDA-regulated products, 62 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: Tobacco product administration and assessment
Other: Tobacco product administration and assessment
Other: Tobacco product administration and assessment
Other: Tobacco product administration and assessment
Other: 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
Change in saliva nicotine concentration
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).
Time frame: 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)
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).
Time frame: 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
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).
Time frame: 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
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).
Time frame: 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
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).
Time frame: Subjective measures of abuse liability will be collected at baseline before the first product administration, 5, 15, 30, and 45 min following each bout.
Expired air carbon monoxide
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).
Time frame: 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
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).
Time frame: 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
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).
Time frame: 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)
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).
Time frame: 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)
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).
Time frame: 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)
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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.
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Virginia Commonwealth University