Young Adults and Low Nicotine Cigarettes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-31

Study Completion Date

2024-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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 Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Participants will be informed that they will be supplied cigarettes with low nicotine content but will be blinded to exact nicotine content and unaware that within-subject, all packages will contain the same type of low nicotine cigarette

Study Groups

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Purple

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

Group Type EXPERIMENTAL

Nicotine content

Intervention Type OTHER

Study-supplied cigarettes will contain either intermediate or very low nicotine content

White

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

Group Type EXPERIMENTAL

Nicotine content

Intervention Type OTHER

Study-supplied cigarettes will contain either intermediate or very low nicotine content

Black

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

Group Type EXPERIMENTAL

Nicotine content

Intervention Type OTHER

Study-supplied cigarettes will contain either intermediate or very low nicotine content

Interventions

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Nicotine content

Study-supplied cigarettes will contain either intermediate or very low nicotine content

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

29 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes