Health TrialsbyHealthPanel

A Study to Assess Nicotine Uptake From Electronic Nicotine Delivery System Products

ConditionsSmoking BehaviorsSmoking ( Cigarette)Tobacco Use
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-60
SponsorRAI Services Company

About this trial

This will be a randomized, open-label, 8-way crossover, single-site study designed to evaluate elements of abuse liability (AL), including subjective effects and physiological measures (pharmacodynamics \[PD\]), and plasma nicotine uptake (pharmacokinetics \[PK\]) during and following ad libitum use of electronic nicotine delivery system (ENDS) investigational products (IPs). The study will be conducted in a confinement setting among generally healthy adult smokers of combustible cigarettes and dual users of cigarettes and ENDS products.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Able to read, understand, and willing to sign an informed consent form (ICF) and complete questionnaires written in English.

Generally healthy male or female, 21 to 60 years of age, inclusive, at the time of consent.

Expired breath carbon monoxide level is ≥ 10 ppm and ≤ 100 ppm at Screening.

Positive urine cotinine test at Screening.

Disqualifiers

Presence of clinically significant uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, gastrointestinal, psychiatric, hematological, neurological disease, or any other concurrent disease or medical condition that, in the opinion of an investigator, makes the study participant unsuitable to participate in this clinical study.

History, presence of, or clinical laboratory test results indicating diabetes.

Systolic blood pressure of > 160 mmHg or a diastolic blood pressure of > 95 mmHg, measured after being seated for five minutes at Screening and at check-in Day -1.

Weight of ≤ 110 pounds (≤ 50.0 kg) at Screening.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Golden Tobacco Chill 5% (4) 6.5W

    Other intervention

    Golden Tobacco Chill 5% (4) 6.5W

  • Glacier Menthol 5% (4) 6.5W

    Other intervention

    Glacier Menthol 5% (4) 6.5W

  • Fresh Mint 5% (4) 6.5W

    Other intervention

    Fresh Mint 5% (4) 6.5W

  • Fresh Mint 5% (4) 4.5W

    Other intervention

    Fresh Mint 5% (4) 4.5W

  • Fresh Mint 5% (3) 6.5W

    Other intervention

    Fresh Mint 5% (3) 6.5W

  • Fresh Mint 5% (3) 5.5W

    Other intervention

    Fresh Mint 5% (3) 5.5W

  • Fresh Mint 5% (2) 6.5W

    Other intervention

    Fresh Mint 5% (2) 6.5W

  • Usual Brand Cigarette

    Other intervention

    Usual Brand Cigarette

Treatment groups

50 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Product usage order BCNDHEGFExperimental treatment 8 interventions
Group B: Product usage order CDBENFHGExperimental treatment 8 interventions
Group C: Product usage order DECFBGNHExperimental treatment 8 interventions
Group D: Product usage order EFDGCHBNExperimental treatment 8 interventions
Group E: Product usage order FGEHDNCBExperimental treatment 8 interventions
Group F: Product usage order GHFNEBDCExperimental treatment 8 interventions
Group G: Product usage order HNGBFCEDExperimental treatment 8 interventions
Group H: Product usage order NBHCGDFEExperimental treatment 8 interventions

Trial outcomes

Primary outcomes

1

AUC nic 3-240

Baseline-adjusted area under the plasma nicotine concentration-versus-time curve from time 3 to 240 minutes after the start of IP use

Time frame
3 minutes to 240 minutes
2

Emax PL

maximum PL VAS score after the start of IP use

Time frame
240 minutes

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

RAI Services Company

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: