Nicotine-Related Studies | IVR, IWR, IRT, ePRO for Clinical Trials

Our team is experienced in providing ePRO, randomization and other clinical trial solutions for Nicotine-related studies.

IVR Clinical Concepts provides Nicotine-related study services including ePRO and IVR/IWR and Clinical Trial Material Management (CTM).

Client Type	Nicotine-Related Research Product Types	IVRCC Services	Description	Countries & Sites	Subjects
Consumer Products Company	Mentholated Cigarette Biomarkers	Randomization Reporting DCF management Audit trail Update data module	Randomization, single-blind, parallel-group, multi-center. Controlled clinical study evaluating biomarkers of tobacco products exposures.	USA, 10 sites	480
Consumer Products Company	eVapor Cigarette Biomarkers	Randomization Reporting DCF management Audit trail Update data module	Evaluate changes in biomarkers of cigarette smoke exposure when smokers switched to e-vapor products.	USA, 10 sites	450
Consumer Products Company	Moist Snuff or Snus Biomarkers Comparison	Randomization Reporting DCF management Audit trail Update data module	Randomized, parallel, four-arm cohort study to compare differences in urinary biomarkers of exposure (BoE) in adult nicotine or tobacco consumers using moist snuff or Snus. 5-day in-clinic confinement.	USA, 6 sites	170
Consumer Products Company	Nicotine pharmacokinetics of P4M3 Gen 2.0 compared to conventional cigarettes (CC)	Subject self-registration to ePRO VAS and questions Reporting	Investigate nicotine PK profiles and subjective effects & related behavioral assessments of 2 electronic nicotine delivery system (ENDS) variants for product evaluation compared to cigarettes.	USA, 10 sites	36
Consumer Products Company	BoE/BoPH of 5 variants of HTP (Heated Tobacco Product) v. conventional cigarettes (CC)	Randomization Reporting DCF management Audit trail Update data module. SMS daily ediary with compliance reporting	Assignment to 8 cohorts. 5 variants plus continue smoking, assisted smoking cessation, never-smokers. IP resupply: dispensations/returns in-clinic & ambulatory.	USA, 20 sites	900
Consumer Products Company	Bioavailability of nicotine delivery from HTP (Heated Tobacco Product) v. conventional cigarettes (CC)	Subject self-registration to web-based ePRO questions and VAS scales Reporting	Randomized cross-over 4 cohorts. 3 variant Heated Tobacco Product (HTP), 1 conventional cigarette (CC)	UK, 1 Site	24
Consumer Products Company	Puffing Topography: 2 cohorts flavors. Open Label, 4 groups self assignment. Glo device, electronic. Product Use and Behavior instrument (PUB)	Subject enrollment tracking IRT product assignment (Open Label and subject selected randomization) Test Product accountability Dispensation to subject with return of unused IP ePRO questionnaires Reporting DCF management Update module	Usual Brand (UB) &/or CC and/or UB HTP to 1 of 4 gloHTP IPs, 2 heating modes. 28 days ambulatory, 14 days acclimation, 14 product test. Multi-center, open-label, parallel-cohort-study, 4 variant HTPs. In support of a Premarket Tobacco Product Application (PMTA) HTP submission to the US Food and Drug Administration (FDA) Center for Tobacco. The study will assess the puffing topography of glo HTP IPs as used.	USA, 4 sites	200-250 enrolled, 200+ completed
Consumer Products Company	Tobacco-free nicotine pouches (NP) PK profiles	IRT, ePRO includes VAS ABOUT Q instruments	Exploratory. Compare PK profiles with commercial nicotine pouches (NPs). Randomization open-label. Williams Design x-over & in-clinic. 6 periods, 6 sequences. Screen, enrollment, confinement, questionnaires, iPad.	UK	96 screened, 24 randomized
Consumer Products Company	Tobacco-free nicotine pouches (NP) v. usual brand CC	IRT-Randomization Potential FDA CTP submission Re: MRTPA Draft Guidance for Industry states that applicants should demonstrate that the product substantially reduces the exposure to substances that are harmful	Open-label, biomarkers of exposure. In-clinic switching parallel-groups, 6 IP and 1 Abstinence.	USA, ~5 sites	~200 for ~160 evaluable