Clinical trial NCT03699865: Young Adults and Low Nicotine Cigarettes
Official title: Young Adults and Low Nicotine Cigarettes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Smoking
Keywords: low nicotine
smoking behaviors
risk perceptions
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2018-10-09
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Randomized, single-blind, 2 x 4 mixed factorial design laboratory-based study manipulating: (1) cigarette pack color (4-level within-subjects factor: own brand vs. white vs. purple vs. black color), and (2) nicotine content (2-level between-subjects factor: moderate vs. very low nicotine content). All participants will provide and smoke their preferred brand for an initial 5-day baseline period, receiver their own brand free-of-charge for 5-days, and then will be randomly assigned to smoke either intermediate or very low LNC cigarettes for the study duration. We will supply participants with LNC cigarettes in three pack colors; each color will be used for a 10-day period, in counter-balanced order.
Primary purpose: OTHER

Brief summary: The purpose of this study is to look at the effects of investigational low nicotine cigarettes on young adult smokers. The investigators are interested in how using these products affects young adults' perceptions and smoking behaviors. This research may help inform the Food and Drug Administration (FDA) how best to regulate tobacco products in the future with the goal of improving public health.

Detailed description: Investigators will recruit 100 young adult cigarette smokers to a 40-day, laboratory-based protocol. You will provide and smoke your preferred brand cigarettes for an initial 5-day baseline period, then receive your own brand free-of-charge for an additional 5-day period, and then will receive free, investigational low nicotine cigarettes for the remaining study duration (i.e., 30 days total). Low nicotine cigarettes will be provided in three varieties; each variety will be used for a 10-day period, in counterbalanced order. Primary outcomes will include smoking behaviors (daily cigarette consumption and total puff volume), harm perceptions (i.e., beliefs about product safety), and tobacco exposure (i.e., carbon monoxide \[CO\]). You will complete in-person visits at the Center for Interdisciplinary Research on Nicotine Addiction (CIRNA) every 5 days, for a total of nine in-person visits.

Eligibility criteria: Inclusion Criteria:

* Study participants will be 100 male and female young adult smokers who:

  * Are aged 18-25
  * Report smoking ≥ 100 lifetime cigarettes
  * Report smoking at least 1 non-menthol, filtered cigarette per day

Exclusion Criteria:

* We will exclude those who:

  * Plan to quit smoking in the next month
  * Smoke menthol cigarettes \> 80% of the time
  * Report consuming ≥ 25 alcohol-containing drinks per week
  * Report a history or current psychiatric diagnosis or severe medical condition,
  * Are color-blind or have another visual impairment (e.g., partial blindness, uncorrected cataract)
  * Are pregnant and/or lactating

Additional, general reasons for exclusion include:

* Significant non-compliance with protocol and/or study design as determined by the Principal Investigator and/or Study Physician. Subjects may be deemed ineligible at any point throughout the study.
* Past, current, anticipated, or pending enrollment in another research program over the study period that could potentially impact subject safety, study data, and/or the study design as determined by the Principal Investigator and/or Study Physician.
* Any medical condition, illness, disorder, adverse event (AE), or concomitant medication that could compromise participant safety or significantly impact study performance as determined by the Principal Investigator and/or Study Physician. Subjects may be deemed ineligible for any of the aforementioned reasons at any point throughout the study, as well as during the initial telephone screen.

Primary outcomes:
measure: Daily cigarette consumption
timeFrame: Days 0 through 40
Secondary outcomes:
measure: Total puff volume
timeFrame: Days 0, 5, 10, 15, 20, 25, 30, 35, and 40
measure: Risk perceptions
timeFrame: Days 10, 20, 30, and 40
measure: Harm exposure
timeFrame: Days 0, 5, 10, 15, 20, 25, 30, 35, and 40
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Melissa Mercincavage, PhD
role: PRINCIPAL_INVESTIGATOR
References: