Evaluating New Nicotine Standards for Cigarettes - Project 3

NCT03194256 | Completed Results DMC

• 2 other identifiers: 1705001771U54DA031659
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to examine how the nicotine content of cigarettes and the nicotine concentration and flavors in e-liquids influence responses to and use of these products in adolescent smokers. Participants will complete a total of six sessions (an in-person screening/baseline session and five lab sessions.

Conditions

Smoking, Cigarette; Electronic Cigarettes

Keywords

Smoking; Cigarettes; E-Cigarettes

Outcome Measures

Primary Outcomes (5)

• Number of Cigarette Puffs Taken (0 to 20)

  The number of cigarette puffs selected during a 30 minute choice procedure when no vaping device was available

  30-minute preference task

• Number of Cigarette Puffs Taken (0 to 20) When the Available Vaping Device Has 3mg/ml of Nicotine and Was Available in Tobacco Flavor

  The number of cigarette puffs selected during a 30 minute choice procedure when the available vaping device has 3mg/ml of nicotine and was available in tobacco flavor

  30-minute preference task

• Number of Cigarette Puffs Taken (0 to 20) When the Available Vaping Device Has 3mg/ml of Nicotine and Was Available in Non-tobacco Flavors

  The number of cigarette puffs selected during a 30 minute choice procedure when the available vaping device has 3mg/ml of nicotine and was available in non-tobacco flavors

  30-minute preference task

• Number of Cigarette Puffs Taken (0 to 20) When the Available Vaping Device Has 18mg/ml of Nicotine and Was Available in Tobacco Flavor

  The number of cigarette puffs selected during a 30 minute choice procedure when the available vaping device has 18mg/ml of nicotine and was available in tobacco flavor

  30-minute preference task

• Number of Cigarette Puffs Taken (0 to 20) When the Available Vaping Device Has 18mg/ml of Nicotine and Was Available in Non-tobacco Flavors

  The number of cigarette puffs selected during a 30 minute choice procedure when the available vaping device has 18mg/ml of nicotine and was available in non-tobacco flavors

  30-minute preference task

Secondary Outcomes (9)

• Number of E-cig Puffs Taken (0 to 20) When the Available Vaping Device Contained 3mg/ml Nicotine and Was Available in Tobacco Flavor

  30-minute preference task session

• Number of E-cig Puffs Taken (0 to 20) When the Available Vaping Device Contained 3mg/ml Nicotine and Was Available in Non-tobacco Flavors

  30-minute preference task session

• Number of E-cig Puffs Taken (0 to 20) When the Available Vaping Device Contained 18mg/ml Nicotine and Was Available in Tobacco Flavor

  30-minute preference task session

• Number of E-cig Puffs Taken (0 to 20) When the Available Vaping Device Contained 18mg/ml Nicotine and Was Available in Non-tobacco Flavors

  30-minute preference task session

• Carbon Monoxide Change From pre-to the Post-choice Task When no Vaping Device Was Available

  30-minute preference task

Other Outcomes (16)

• Number of Choices for Cigarette Puffs

  30-minute preference task at each of the 5 laboratory sessions

• Number of Choices for E-cig Puffs

  30-minute preference task at each of the 5 laboratory sessions

• Number of Choices to Abstain From Puffing

  30-minute preference task at each of the 5 laboratory sessions

Study Arms (2)

Normal Nicotine Content Cigarettes

ACTIVE COMPARATOR

Spectrum Research Cigarettes: 15.8 mg nicotine/g tobacco, 9 mg of tar

Behavioral: Spectrum Research Cigarettes

Very Low Nicotine Content Cigarettes

EXPERIMENTAL

Spectrum Research Cigarettes: 0.4 mg nicotine/g tobacco, 9 mg of tar

Behavioral: Spectrum Research Cigarettes

Interventions

Spectrum Research Cigarettes BEHAVIORAL

Participants will be assigned to either normal nicotine content cigarettes or very low nicotine content cigarettes.

Normal Nicotine Content Cigarettes; Very Low Nicotine Content Cigarettes

Eligibility Criteria

• Age: 15 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Ages 15-20
• Adolescents who report current daily or near daily cigarette smoking for at least 3 months
• Must have used an electronic nicotine device on a minimum of two lifetime occasions.
• Breath Carbon Monoxide (CO) levels \> 5 ppm (if \< 5 ppm, then cotinine assay via NicAlert Strip = \> 3)
• Speak, comprehend, and read English well enough to complete study procedures

You may not qualify if:

• Unwilling to use research cigarettes or ENDS as part of the study
• Intention to quit smoking in the next 30 days
• Using tobacco products (other than ENDS or roll-your-own tobacco) \> 15 days in the past 30 days.
• Any medical or psychiatric condition in which participation is likely to post a significant threat to health or for which the condition could interfere with the ability of the participant to fully participants (as determined by the LMP)
• Self-reported illicit use of any drug except marijuana \> 10 days in the past 30 days
• Binge drinking alcohol (\>10 days in the past 30 days, \>4/5 drinks in a 2-hour period (female/male))
• Pregnant or breastfeeding
• CO reading \> 80 ppm
• Systolic BP outside the range of 90-159, diastolic BP outside the range of 50-99, or heart rate outside the range of 45-104. Participants failing for any of these criteria will be allowed to re-screen once per criterion.
• Indicating Yes on Questions 4-6 on the MINI with a suicide attempt in the past 2 years (if within the past 2-10 years, LMP approval required).
• Having participated in another research study during the past year in which they were switched to reduced nicotine cigarettes for longer than one week.

Sponsors & Collaborators

• Brown University: lead
• Wake Forest University: collaborator
• University of Minnesota: collaborator
• National Institute on Drug Abuse (NIDA): collaborator
• Food and Drug Administration (FDA): collaborator

Study Sites (1)

Brown University School of Public Health

Providence, Rhode Island, 02912, United States

Location

MeSH Terms

Conditions

Cigarette Smoking; Vaping; Smoking

Condition Hierarchy (Ancestors)

Tobacco Smoking; Behavior; Tobacco Use

Results Point of Contact

• Title: Suzanne Colby
• Organization: Brown University

suzanne_colby@brown.edu

4028636621

Study Officials

• Suzanne Colby, PhD

  Brown University

  PRINCIPAL INVESTIGATOR

• Jennifer Tidey, PhD

  Brown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be blind to the nicotine content of their assigned study cigarette and the nicotine dose of the e-liquid in the study vaping device. Investigators, research staff, and biostatisticians will also be blind to the conditions. E-liquid flavors will not be blinded.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Mixed between subjects and within-subjects design. Random assignment to the between subjects factor (nicotine content in cigarettes), within-subjects manipulation of nicotine concentration and flavors in e-liquid in the electronic cigarettes

Study Record Dates

• First Submitted: June 7, 2017
• First Posted: June 21, 2017
• Study Start: September 1, 2018
• Primary Completion: October 28, 2022
• Study Completion: November 30, 2022
• Last Updated: December 18, 2023
• Results First Posted: December 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will not be available until primary and secondary papers are accepted for publication.
• Access Criteria: Persons requesting data must do so in writing, identifying their affiliation and how the data will be used. Upon review, access will be determined.

Locations

US (1)