Young Adults and Low Nicotine Cigarettes (YLP)

Abramson Cancer Center at Penn Medicine

Status: Withdrawn

Conditions: Smoking

Treatments: Other: Nicotine content

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03699865

UPCC 10021

1K07CA218366-01A1 (U.S. NIH Grant/Contract)

829101

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 21 to 29 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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0 participants in 3 patient groups

Purple

Experimental group

Description:

Participants will receive cigarettes with intermediate or very low nicotine content in purple packaging

Treatment:

Other: Nicotine content

White

Experimental group

Description:

Participants will receive cigarettes with intermediate or very low nicotine content in white packaging

Treatment:

Other: Nicotine content

Black

Experimental group

Description:

Participants will receive cigarettes with intermediate or very low nicotine content in black packaging

Treatment:

Other: Nicotine content