Project 2 Cigarette and E-cigarette Nicotine Content and E-liquid Flavors

Summary

Project 2 will evaluate the impact of very low nicotine content cigarettes, e-cigarette nicotine content, and e-cigarette flavoring on cigarettes smoked per day, nicotine exposure, puff topography, discomfort/dysfunction, other health-related behaviors, nicotine/tobacco dependence, biomarkers of tobacco exposure, intention to quit, compensatory smoking, other tobacco use, cardiovascular function, and perceived risk. Project 2 will also evaluate differences between conditions in compliance with product use and the ability to abstain from cigarette smoking when provided a financial incentive for abstinence from combusted tobacco. This is not a treatment program for smoking.

Conditions

• Smoking

Interventions

OTHER

NNC Spectrum Cigarette

Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.

OTHER

VLNC Spectrum Cigarette

Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks

OTHER

Moderate nicotine level e-liquid

Participants are provided with moderate nicotine level e-liquid for 13 weeks

OTHER

Low nicotine level e-liquid

Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks

OTHER

Tobacco Flavors

Participants can choose e-liquid flavors from a selection of tobacco flavors

OTHER

Tobacco and non-tobacco e-liquid flavors

Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices

Sponsors & Collaborators

• University of Pennsylvania

  collaborator OTHER

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• Wake Forest University Health Sciences

  lead OTHER

Principal Investigators

• Eric Donny, PhD · Wake Forest University Health Sciences

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-08-06

Primary Completion

2020-03-13

Completion

2020-03-13

Countries

• United States

Study Locations