Cigarette and E-cigarette Nicotine Content in an Electronic Tobacco Marketplace (ETM)

NCT05320887 | Completed Results DMC

• 2 other identifiers: IRB000800105U54DA031659-09
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

This study is proposing a four condition Electronic Tobacco Marketplace (ETM) study to determine if banning normal nicotine content (NNC) is sufficient for encouraging smokers to switch to potentially less harmful products or if the availability of higher nicotine and/or flavored alternative products (specifically e-cigarettes) are needed to achieve maximal reductions in smoking.

Conditions

Tobacco Use

Keywords

Cigarette smoking

Outcome Measures

Primary Outcomes (1)

• Number of Cigarettes Purchased

  Average number of cigarettes purchased (analyzed as raw data and using derived behavioral economic measures)

  Visit 6 approximately 4 weeks after baseline

Secondary Outcomes (8)

• Number of E-liquid Milliliters Purchased

  Visit 6 approximately 4 weeks after baseline

• Proportion of Participants Completing Flavor and Nicotine Content Discrete Choice Projections

  Month 1 after baseline

• Lung Cancer Perceived Risk Scores for VLNC Cigarettes

  Baseline

• Product Evaluation Scale Scores

  Visit 6 approximately 4 weeks after baseline

• Minnesota Nicotine Withdrawal Scale Scores

  Visit 6 approximately 4 weeks after baseline

Other Outcomes (4)

• Product Use Themes Emerging From the Qualitative Interviews

  Screening visit through end of study (up to week eight)

• Tobacco Product Use During Field Assessment

  Screening visit through end of study (up to week eight)

• Biomarkers of Exposure During Field Assessment - Carbon Monoxide

  Screening visit through end of study (up to week eight)

Study Arms (4)

Normal Nicotine Content Vape with all flavor e-liquids

EXPERIMENTAL

Normal Nicotine Content Vape with all flavor e-liquids

Other: Normal Nicotine Content Vape with all flavor e-liquids

Normal nicotine content vape with tobacco e-liquids

EXPERIMENTAL

Normal nicotine content vape with tobacco e-liquids

Other: Normal nicotine content vape with tobacco e-liquids

Low nicotine content vape with all flavor e-liquids

EXPERIMENTAL

Low nicotine content vape with all flavor e-liquids

Other: Low nicotine content vape with all flavor e-liquids

Low nicotine content vape with tobacco e-liquids

EXPERIMENTAL

Low nicotine content vape with tobacco e-liquids

Other: Low nicotine content vape with tobacco e-liquids

Interventions

Normal Nicotine Content Vape with all flavor e-liquids OTHER

Participants are randomly assigned to the order of each marketplace Group

Normal Nicotine Content Vape with all flavor e-liquids

Normal nicotine content vape with tobacco e-liquids OTHER

Participants are randomly assigned to the order of each marketplace Group

Normal nicotine content vape with tobacco e-liquids

Low nicotine content vape with all flavor e-liquids OTHER

Participants are randomly assigned to the order of each marketplace Group

Low nicotine content vape with all flavor e-liquids

Low nicotine content vape with tobacco e-liquids OTHER

Participants are randomly assigned to the order of each marketplace Group

Low nicotine content vape with tobacco e-liquids

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + years of age
• Self-report smoking at least 5 cigarettes per day for the past year
• Breathe carbon monoxide (CO) level \> 8 ppm or positive urine NicCheck
• Willingness to use other tobacco products during the study
• Speak, comprehend, and read English sufficiently to complete study procedures
• Have home access to a computer, smart phone, or tablet with a web camera and internet access
• Tried a vaping device at least once in their lifetime

You may not qualify if:

• Currently seeking treatment to quit smoking
• Self-reported serious medical or psychiatric condition(s) including cardiovascular and chronic respiratory diseases
• Body temperature \> 100.4 F
• Cold, flu or COVID-19 symptoms including fever, cough, and runny nose in the past 30 days
• Currently pregnant, breastfeeding or intending to become pregnant for the duration of the study or unwilling to agree to use adequate protection to avoid pregnancy
• CO reading \> 80 ppm

Sponsors & Collaborators

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

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (8)

• Jarvis MJ, Bates C. Eliminating nicotine in cigarettes. Tob Control. 1999 Spring;8(1):106-7; author reply 107-9. No abstract available.

  PMID: 10465828 BACKGROUND

• Kozlowski LT. Prospects for a nicotine-reduction strategy in the cigarette endgame: Alternative tobacco harm reduction scenarios. Int J Drug Policy. 2015 Jun;26(6):543-7. doi: 10.1016/j.drugpo.2015.02.001. Epub 2015 Feb 23.

  PMID: 25795345 BACKGROUND

• Kozlowski LT. Cigarette prohibition and the need for more prior testing of the WHO TobReg's global nicotine-reduction strategy. Tob Control. 2017 Mar;26(e1):e31-e34. doi: 10.1136/tobaccocontrol-2016-052995. Epub 2016 Jun 29. No abstract available.

  PMID: 27357937 BACKGROUND

• Kozlowski LT. Let actual markets help assess the worth of optional very-low-nicotine cigarettes before deciding on mandatory regulations. Addiction. 2017 Jan;112(1):3-5. doi: 10.1111/add.13515. Epub 2016 Aug 23. No abstract available.

  PMID: 27554993 BACKGROUND

• Shatenstein S. Eliminating nicotine in cigarettes. Tob Control. 1999 Spring;8(1):106; author reply 107-9. No abstract available.

  PMID: 10465827 BACKGROUND

• Henningfield JE, Benowitz NL, Slade J, Houston TP, Davis RM, Deitchman SD. Reducing the addictiveness of cigarettes. Council on Scientific Affairs, American Medical Association. Tob Control. 1998 Autumn;7(3):281-93. doi: 10.1136/tc.7.3.281.

  PMID: 9825424 BACKGROUND

• Hatsukami DK, Perkins KA, Lesage MG, Ashley DL, Henningfield JE, Benowitz NL, Backinger CL, Zeller M. Nicotine reduction revisited: science and future directions. Tob Control. 2010 Oct;19(5):e1-10. doi: 10.1136/tc.2009.035584.

  PMID: 20876072 BACKGROUND

• World Health Organization. WHO STUDY GROUP ON TOBACCO PRODUCT REGULATION. Report on the Scientific Basis of Tobacco Product Regulations: Fifth Report of a WHO Study Group. World Health Organ Tech Rep Ser. 2015;(989):1-234, back cover.

  PMID: 26353746 BACKGROUND

MeSH Terms

Conditions

Tobacco Use; Cigarette Smoking

Condition Hierarchy (Ancestors)

Behavior; Tobacco Smoking; Smoking

Results Point of Contact

• Title: Darcy Lockhart, Project Manager I
• Organization: Wake Forest School of Medicine

alaverdi@wakehealth.edu

3367166182

Study Officials

• Eric M 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: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are told their shopping trips are randomly selected, when they are actually being randomly selected between the two marketplace groups where only one flavor of e-liquid is available.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomly assigned to either low nicotine or normal nicotine content vaping devices with tobacco flavors only available

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: April 11, 2022
• Study Start: July 27, 2022
• Primary Completion: July 31, 2023
• Study Completion: August 6, 2023
• Last Updated: October 9, 2024
• Results First Posted: October 9, 2024

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)