Evaluating New Nicotine Standards for Cigarettes - Project 3

Smoking, Cigarette Clinical Trial

— CENIC2-P3  

Official title:

Effects of Very Low Nicotine Content Cigarettes and E-cigarette Characteristics on Smoking in Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03194256
• Other study ID #: 1705001771
• Secondary ID: U54DA031659
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: November 30, 2022

Study information

• Verified date: November 2023
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Adolescence is a critical developmental period for tobacco initiation and progression to regular use and dependence. The Food and Drug Administration (FDA) has the authority to establish standards for tobacco products for the protection of public health, including the authority to mandate a reduction in the nicotine content of all cigarettes to minimally addictive levels. Numerous studies have found that adult smokers who are switched to very low nicotine content (VLNC) cigarettes experience reductions in smoking rates, nicotine intake, nicotine dependence and abstinence-induced craving relative to those who use normal nicotine content (NNC) cigarettes. However, studies of VLNC cigarettes in adolescent smokers are limited and more information is needed to inform potential product standards. Furthermore, use of electronic nicotine delivery systems (ENDS), e-cigarettes or vaping devices, has increased dramatically in adolescents. Therefore, effects of VLNC cigarettes on smoking in youth should be examined in the context of vaping device availability. This study is designed to examine how the nicotine content of cigarettes and the nicotine concentration and flavors in e-liquids influence responses to these products in adolescents.

Participants will complete an in-person baseline session in which eligibility criteria are confirmed and background questionnaires are completed. Next, participants will complete five in-person lab sessions in which NNC or VLNC cigarettes are available (based on random assignment). During the first lab session, participants will test the assigned research cigarettes when no alternative product is available. During each of the four remaining lab sessions, smokers' responses to the assigned research cigarettes will be compared to their responses to a vaping device with the following characteristics: 1) no nicotine, tobacco flavor; 2) no nicotine, non-tobacco flavor; 3) moderate nicotine concentration, tobacco flavor; or 4) moderate nicotine concentration, non-tobacco flavor. In each session, after sampling and rating the subjective effects of the products available during that session, participants will make a series of 10 choices. Choices will be for either 2 puffs of the research cigarette, 2 puffs of the vaping device, or abstinence from puffing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 30, 2022
• Est. primary completion date: October 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 20 Years

Eligibility

Inclusion Criteria:

1. Ages 15-20

2. Adolescents who report current daily or near daily cigarette smoking for at least 3 months

3. Must have used an electronic nicotine device on a minimum of two lifetime occasions.

4. Breath Carbon Monoxide (CO) levels > 5 ppm (if < 5 ppm, then cotinine assay via NicAlert Strip = > 3)

5. Speak, comprehend, and read English well enough to complete study procedures

Exclusion Criteria:

1. Unwilling to use research cigarettes or ENDS as part of the study

2. Intention to quit smoking in the next 30 days

3. Using tobacco products (other than ENDS or roll-your-own tobacco) > 15 days in the past 30 days.

4. 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)

5. Self-reported illicit use of any drug except marijuana > 10 days in the past 30 days

6. Binge drinking alcohol (>10 days in the past 30 days, >4/5 drinks in a 2-hour period (female/male))

7. Pregnant or breastfeeding

8. CO reading > 80 ppm

9. 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.

10. 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).

11. Having participated in another research study during the past year in which they were switched to reduced nicotine cigarettes for longer than one week.

Related Conditions & MeSH terms

• Electronic Cigarettes
• Smoking, Cigarette

Intervention

Behavioral:
• Spectrum Research Cigarettes
Participants will be assigned to either normal nicotine content cigarettes or very low nicotine content cigarettes.

Locations

Country	Name	City	State
United States	Brown University School of Public Health	Providence	Rhode Island

Sponsors (5)

Lead Sponsor	Collaborator
Brown University	Food and Drug Administration (FDA), National Institute on Drug Abuse (NIDA), University of Minnesota, Wake Forest University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Choices for Cigarette Puffs	0 to 10	30-minute preference task at each of the 5 laboratory sessions
Other	Number of Choices for E-cig Puffs	0 to 10	30-minute preference task at each of the 5 laboratory sessions
Other	Number of Choices to Abstain From Puffing	0 to 10	30-minute preference task at each of the 5 laboratory sessions
Other	Drop-out Rate	Measures of compliance	Baseline-Lab Session 5; 2-8 weeks; average 3-4 weeks
Other	Minnesota Nicotine Withdrawal Scale (MNWS)	Measures withdrawal symptoms	Baseline-Lab Session 5; 2-8 weeks; average 3-4 weeks
Other	Questionnaire of Smoking Urges (QSU)	Measures craving	Baseline-Lab Session 5; 2-8 weeks; average 3-4 weeks
Other	Positive and Negative Affect Scale (PANAS)	Measures positive and negative affect	Baseline-Lab Session 5; 2-8 weeks; average 3-4 weeks
Other	Cigarette Evaluation Scale (CES)	Measures subjective responses cigarettes	Baseline-Lab Session 5; 2-8 weeks; average 3-4 weeks
Other	Cigarette Purchase Task	Measures demand for cigarettes across a range of prices	Baseline-Lab Session 5; 2-8 weeks; average 3-4 weeks
Other	Perceived Health Risk Scale	Measures perceived risk of cigarettes	Baseline-Lab Session 5; 2-8 weeks; average 3-4 weeks
Other	Heart Rate	Measures of cardiovascular function	Baseline-Lab Session 5; 2-8 weeks; average 3-4 weeks
Other	Blood Pressure	Measures of cardiovascular function	Baseline-Lab Session 5; 2-8 weeks; average 3-4 weeks
Other	Total Nicotine Equivalents (TNE)	Biomarkers	Baseline; Week 1
Other	Nicotine Metabolite Ratio (NMR)	Biomarkers	Baseline; Week 1
Other	Cotinine	Biomarkers: measures a metabolite of nicotine	Baseline; Week 1
Other	Carbon Monoxide (CO)	Biomarkers: measures expired alveolar carbon monoxide level	Baseline-Lab Session 5; 2-8 weeks; average 3-4 weeks
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Number of E-cig Puffs Taken (0 to 20) When the Available Vaping Device Contained 3mg/ml Nicotine and Was Available in Tobacco Flavor	The number of cigarette puffs selected during a 30 minute choice procedure when the available vaping device contained 3mg/ml nicotine and was available in tobacco flavor	30-minute preference task session
Secondary	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	The number of cigarette puffs selected during a 30 minute choice procedure when the available vaping device contained 3mg/ml nicotine and was available in non-tobacco flavors	30-minute preference task session
Secondary	Number of E-cig Puffs Taken (0 to 20) When the Available Vaping Device Contained 18mg/ml Nicotine and Was Available in Tobacco Flavor	The number of cigarette puffs selected during a 30 minute choice procedure when the available vaping device contained 18mg/ml nicotine and was available in tobacco flavor	30-minute preference task session
Secondary	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	The number of cigarette puffs selected during a 30 minute choice procedure when the available vaping device contained 18mg/ml nicotine and was available in non-tobacco flavors	30-minute preference task session
Secondary	Carbon Monoxide Change From pre-to the Post-choice Task When no Vaping Device Was Available	Post-choice CO minus pre-choice CO at session 1 in which no vaping device was available	30-minute preference task
Secondary	Carbon Monoxide Change From pre-to the Post-choice Task When the Available Vaping Device Contained 3mg/ml Nicotine and Was Available in Tobacco Flavor	Post-choice CO minus pre-choice CO when the available vaping device contained 3mg/ml nicotine and was available in tobacco flavor	30-minute preference task
Secondary	Carbon Monoxide Change From pre-to the Post-choice Taskwhen the Available Vaping Device Contained 3mg/ml Nicotine and Was Available in Non-tobacco Flavors	Post-choice CO minus pre-choice CO when the available vaping device contained 3mg/ml nicotine and was available in non-tobacco flavors	30-minute preference task
Secondary	Carbon Monoxide Change From pre-to the Post-choice Task When the Available Vaping Device Contained 18mg/ml Nicotine and Was Available in Tobacco Flavor	Post-choice CO minus pre-choice CO when the available vaping device contained 18mg/ml nicotine and was available in tobacco flavor	30-minute preference task
Secondary	Carbon Monoxide Change From pre-to the Post-choice Task When the Available Vaping Device Contained 18mg/ml Nicotine and Was Available in Non-tobacco Flavors	Post-choice CO minus pre-choice CO when the available vaping device contained 18mg/ml nicotine and was available in non-tobacco flavors	30-minute preference task