Clinical trial NCT03194256: Evaluating New Nicotine Standards for Cigarettes - Project 3
Official title: Effects of Very Low Nicotine Content Cigarettes and E-cigarette Characteristics on Smoking in Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking, Cigarette
Electronic Cigarettes
Keywords: Smoking
Cigarettes
E-Cigarettes
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: Wake Forest University
name: University of Minnesota
name: National Institute on Drug Abuse (NIDA)
name: Food and Drug Administration (FDA)
First posted: 2017-06-21
Enrollment: 80
Sex: ALL
Minimum age (years): 15
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: OTHER

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Cigarette Puffs Taken (0 to 20)
timeFrame: 30-minute preference task
measure: Number of Cigarette Puffs Taken (0 to 20) When the Available Vaping Device Has 3mg/ml of Nicotine and Was Available in Tobacco Flavor
timeFrame: 30-minute preference task
measure: 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
timeFrame: 30-minute preference task
measure: Number of Cigarette Puffs Taken (0 to 20) When the Available Vaping Device Has 18mg/ml of Nicotine and Was Available in Tobacco Flavor
timeFrame: 30-minute preference task
measure: 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
timeFrame: 30-minute preference task
Secondary outcomes:
measure: Number of E-cig Puffs Taken (0 to 20) When the Available Vaping Device Contained 3mg/ml Nicotine and Was Available in Tobacco Flavor
timeFrame: 30-minute preference task session
measure: 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
timeFrame: 30-minute preference task session
measure: Number of E-cig Puffs Taken (0 to 20) When the Available Vaping Device Contained 18mg/ml Nicotine and Was Available in Tobacco Flavor
timeFrame: 30-minute preference task session
measure: 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
timeFrame: 30-minute preference task session
measure: Carbon Monoxide Change From pre-to the Post-choice Task When no Vaping Device Was Available
timeFrame: 30-minute preference task
measure: 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
timeFrame: 30-minute preference task
measure: 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
timeFrame: 30-minute preference task
measure: 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
timeFrame: 30-minute preference task
measure: 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
timeFrame: 30-minute preference task
Other outcomes:
measure: Number of Choices for Cigarette Puffs
timeFrame: 30-minute preference task at each of the 5 laboratory sessions
measure: Number of Choices for E-cig Puffs
timeFrame: 30-minute preference task at each of the 5 laboratory sessions
measure: Number of Choices to Abstain From Puffing
timeFrame: 30-minute preference task at each of the 5 laboratory sessions
measure: Drop-out Rate
timeFrame: Baseline-Lab Session 5; 2-8 weeks; average 3-4 weeks
measure: Minnesota Nicotine Withdrawal Scale (MNWS)
timeFrame: Baseline-Lab Session 5; 2-8 weeks; average 3-4 weeks
measure: Questionnaire of Smoking Urges (QSU)
timeFrame: Baseline-Lab Session 5; 2-8 weeks; average 3-4 weeks
measure: Positive and Negative Affect Scale (PANAS)
timeFrame: Baseline-Lab Session 5; 2-8 weeks; average 3-4 weeks
measure: Cigarette Evaluation Scale (CES)
timeFrame: Baseline-Lab Session 5; 2-8 weeks; average 3-4 weeks
measure: Cigarette Purchase Task
timeFrame: Baseline-Lab Session 5; 2-8 weeks; average 3-4 weeks
measure: Perceived Health Risk Scale
timeFrame: Baseline-Lab Session 5; 2-8 weeks; average 3-4 weeks
measure: Heart Rate
timeFrame: Baseline-Lab Session 5; 2-8 weeks; average 3-4 weeks
measure: Blood Pressure
timeFrame: Baseline-Lab Session 5; 2-8 weeks; average 3-4 weeks
measure: Total Nicotine Equivalents (TNE)
timeFrame: Baseline; Week 1
measure: Nicotine Metabolite Ratio (NMR)
timeFrame: Baseline; Week 1
measure: Cotinine
timeFrame: Baseline; Week 1
measure: Carbon Monoxide (CO)
timeFrame: Baseline-Lab Session 5; 2-8 weeks; average 3-4 weeks
Locations:
city: Providence
country: United States
facility: Brown University School of Public Health
state: Rhode Island
Study officials:
affiliation: Brown University
name: Suzanne Colby, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brown University
name: Jennifer Tidey, PhD
role: PRINCIPAL_INVESTIGATOR
References: