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

NCT03185546 | Completed Results DMC

• 3 other identifiers: IRB000476761U54DA031659-01U54DA031659-06
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

smoking; vaping

Outcome Measures

Primary Outcomes (1)

• Total Cigarettes Smoked Per Day

  The average number of cigarettes (study and non-study, summed) smoked per day between the Week 10 and Week 12 visits (the end of the study).

  Week 10 through Week 12

Secondary Outcomes (2)

• Measure of Cigarette Exposure Using Expired Carbon Monoxide (CO)

  Baseline - Week 12

• Number of Subjects With Smoke Free Days

  Baseline-Week 12

Other Outcomes (36)

• Minnesota Nicotine Withdrawal Scale

  Baseline-Week 12

• Number of Days Using Assigned Vaping Device

  Baseline-Week 12

• Cigarette Evaluation Scale

  Baseline-Week 12

Study Arms (8)

Normal Nicotine Content (NNC) cigarette + moderate nicotine e-liquid + tobacco flavors

EXPERIMENTAL

Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.

Other: NNC Spectrum Cigarette; Other: Moderate nicotine level e-liquid; Other: Tobacco Flavors

NNC cigarette + low nicotine e-liquid + tobacco flavors

EXPERIMENTAL

Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with very low nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.

Other: NNC Spectrum Cigarette; Other: Low nicotine level e-liquid; Other: Tobacco Flavors

NNC cigarette + moderate nicotine e-liquid + variety flavors

EXPERIMENTAL

Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors.

Other: NNC Spectrum Cigarette; Other: Moderate nicotine level e-liquid; Other: Tobacco and non-tobacco e-liquid flavors

NNC cigarette + low nicotine e-liquid + variety flavors

EXPERIMENTAL

Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with very low or nicotine-free nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors

Other: NNC Spectrum Cigarette; Other: Low nicotine level e-liquid; Other: Tobacco and non-tobacco e-liquid flavors

Very Low Nicotine Content (VLNC) cigarette + moderate nicotine e-liquid + tobacco flavor

EXPERIMENTAL

Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.

Other: VLNC Spectrum Cigarette; Other: Moderate nicotine level e-liquid; Other: Tobacco Flavors

VLNC cigarette + low nicotine e-liquid +tobacco flavors

EXPERIMENTAL

Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with very low or nicotine-free nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors.

Other: VLNC Spectrum Cigarette; Other: Low nicotine level e-liquid; Other: Tobacco Flavors

VLNC cigarette + moderate nicotine e-liquid + variety flavors

EXPERIMENTAL

Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors.

Other: VLNC Spectrum Cigarette; Other: Moderate nicotine level e-liquid; Other: Tobacco and non-tobacco e-liquid flavors

VLNC cigarette + low nicotine e-liquid + variety flavors

EXPERIMENTAL

Participants are provided with very low or nicotine-free nicotine content tobacco Spectrum Cigarettes along with very low nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors

Other: VLNC Spectrum Cigarette; Other: Low nicotine level e-liquid; Other: Tobacco and non-tobacco e-liquid flavors

Interventions

NNC Spectrum Cigarette OTHER

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

NNC cigarette + low nicotine e-liquid + tobacco flavors; NNC cigarette + low nicotine e-liquid + variety flavors; NNC cigarette + moderate nicotine e-liquid + variety flavors; Normal Nicotine Content (NNC) cigarette + moderate nicotine e-liquid + tobacco flavors

VLNC Spectrum Cigarette OTHER

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

VLNC cigarette + low nicotine e-liquid + variety flavors; VLNC cigarette + low nicotine e-liquid +tobacco flavors; VLNC cigarette + moderate nicotine e-liquid + variety flavors; Very Low Nicotine Content (VLNC) cigarette + moderate nicotine e-liquid + tobacco flavor

Moderate nicotine level e-liquid OTHER

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

NNC cigarette + moderate nicotine e-liquid + variety flavors; Normal Nicotine Content (NNC) cigarette + moderate nicotine e-liquid + tobacco flavors; VLNC cigarette + moderate nicotine e-liquid + variety flavors; Very Low Nicotine Content (VLNC) cigarette + moderate nicotine e-liquid + tobacco flavor

Low nicotine level e-liquid OTHER

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

NNC cigarette + low nicotine e-liquid + tobacco flavors; NNC cigarette + low nicotine e-liquid + variety flavors; VLNC cigarette + low nicotine e-liquid + variety flavors; VLNC cigarette + low nicotine e-liquid +tobacco flavors

Tobacco Flavors OTHER

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

NNC cigarette + low nicotine e-liquid + tobacco flavors; Normal Nicotine Content (NNC) cigarette + moderate nicotine e-liquid + tobacco flavors; VLNC cigarette + low nicotine e-liquid +tobacco flavors; Very Low Nicotine Content (VLNC) cigarette + moderate nicotine e-liquid + tobacco flavor

Tobacco and non-tobacco e-liquid flavors OTHER

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

NNC cigarette + low nicotine e-liquid + variety flavors; NNC cigarette + moderate nicotine e-liquid + variety flavors; VLNC cigarette + low nicotine e-liquid + variety flavors; VLNC cigarette + moderate nicotine e-liquid + variety flavors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Smokers who have tried vaping multiple times.
• Generally good health.

You may not qualify if:

• If female, currently pregnant, trying to become pregnant or breastfeeding.
• Planning to quit smoking.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• University of Pennsylvania: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

Wake Forest Biotech Place

Winston-Salem, North Carolina, 27101, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

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MeSH Terms

Conditions

Smoking; Vaping

Interventions

Tobacco Products

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Eric Donny, PhD
• Organization: Wake Forest School of Medicine

edonny@wakehealth.edu

336-713-1520

Study Officials

• Eric Donny, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2017
• First Posted: June 14, 2017
• Study Start: August 6, 2018
• Primary Completion: March 13, 2020
• Study Completion: March 13, 2020
• Last Updated: May 14, 2021
• Results First Posted: May 14, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share

Locations

US (2)