Reactions to Reduced Nicotine Cigarettes in Young Adult Low-Frequency Smokers

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

COMPLETED

Clinical Phase

NA

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2019-12-17

Brief Summary

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The purpose of this study is to evaluate reactions to, and choices to self-administer, cigarette smoke with varying nicotine content among low-frequency, non-dependent adolescent/young adult smokers between the ages of 15-25 years.

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Detailed Description

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Participants will undergo three sessions in which their reactions to fixed doses of smoke from investigational cigarettes with three different nicotine contents (15.8 mg/gram of tobacco, 2.5 mg/g, and .4 mg/g) will be assessed. Following the third fixed-dose session, participants will return to the lab to choose one of the cigarettes to self-administer.

Conditions

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Nicotine Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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NNC, INC, VLNC

Normal Nicotine Content (NNC), Intermediate Nicotine Content (INC), Very Low Nicotine Content (VLNC)

Group Type EXPERIMENTAL

Very Low Nicotine Content Cigarettes

Intervention Type OTHER

cigarettes with 0.03 nicotine yield with 0.4 mg/g nicotine content and 9.0 mg tar yield

Intermediate Nicotine Content Cigarettes

Intervention Type OTHER

cigarettes with 0.12 nicotine yield with 2.4 mg/g nicotine content and 9.0 mg tar yield

Normal Nicotine Content Cigarettes

Intervention Type OTHER

cigarettes with 0.8 nicotine yield with 15.8 mg/g nicotine content and 10.5 mg tar yield

NNC, VLNC, INC

Normal Nicotine Content, Very Low Nicotine Content, Intermediate Nicotine Content

Group Type EXPERIMENTAL

Very Low Nicotine Content Cigarettes

Intervention Type OTHER

cigarettes with 0.03 nicotine yield with 0.4 mg/g nicotine content and 9.0 mg tar yield

Intermediate Nicotine Content Cigarettes

Intervention Type OTHER

cigarettes with 0.12 nicotine yield with 2.4 mg/g nicotine content and 9.0 mg tar yield

Normal Nicotine Content Cigarettes

Intervention Type OTHER

cigarettes with 0.8 nicotine yield with 15.8 mg/g nicotine content and 10.5 mg tar yield

INC, VLNC, NNC

Intermediate Nicotine Content, Very Low Nicotine Content, Normal Nicotine Content

Group Type EXPERIMENTAL

Very Low Nicotine Content Cigarettes

Intervention Type OTHER

cigarettes with 0.03 nicotine yield with 0.4 mg/g nicotine content and 9.0 mg tar yield

Intermediate Nicotine Content Cigarettes

Intervention Type OTHER

cigarettes with 0.12 nicotine yield with 2.4 mg/g nicotine content and 9.0 mg tar yield

Normal Nicotine Content Cigarettes

Intervention Type OTHER

cigarettes with 0.8 nicotine yield with 15.8 mg/g nicotine content and 10.5 mg tar yield

INC, NNC, VLNC

Intermediate Nicotine Content, Normal Nicotine Content, Very Low Nicotine Content

Group Type EXPERIMENTAL

Very Low Nicotine Content Cigarettes

Intervention Type OTHER

cigarettes with 0.03 nicotine yield with 0.4 mg/g nicotine content and 9.0 mg tar yield

Intermediate Nicotine Content Cigarettes

Intervention Type OTHER

cigarettes with 0.12 nicotine yield with 2.4 mg/g nicotine content and 9.0 mg tar yield

Normal Nicotine Content Cigarettes

Intervention Type OTHER

cigarettes with 0.8 nicotine yield with 15.8 mg/g nicotine content and 10.5 mg tar yield

VLNC, NNC, INC

Very Low Nicotine Content, Normal Nicotine Content, Intermediate Nicotine Content

Group Type EXPERIMENTAL

Very Low Nicotine Content Cigarettes

Intervention Type OTHER

cigarettes with 0.03 nicotine yield with 0.4 mg/g nicotine content and 9.0 mg tar yield

Intermediate Nicotine Content Cigarettes

Intervention Type OTHER

cigarettes with 0.12 nicotine yield with 2.4 mg/g nicotine content and 9.0 mg tar yield

Normal Nicotine Content Cigarettes

Intervention Type OTHER

cigarettes with 0.8 nicotine yield with 15.8 mg/g nicotine content and 10.5 mg tar yield

VLNC, INC, NNC

Very Low Nicotine Content, Intermediate Nicotine Content, Normal Nicotine Content

Group Type EXPERIMENTAL

Very Low Nicotine Content Cigarettes

Intervention Type OTHER

cigarettes with 0.03 nicotine yield with 0.4 mg/g nicotine content and 9.0 mg tar yield

Intermediate Nicotine Content Cigarettes

Intervention Type OTHER

cigarettes with 0.12 nicotine yield with 2.4 mg/g nicotine content and 9.0 mg tar yield

Normal Nicotine Content Cigarettes

Intervention Type OTHER

cigarettes with 0.8 nicotine yield with 15.8 mg/g nicotine content and 10.5 mg tar yield

Interventions

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Very Low Nicotine Content Cigarettes

cigarettes with 0.03 nicotine yield with 0.4 mg/g nicotine content and 9.0 mg tar yield

Intervention Type OTHER

Intermediate Nicotine Content Cigarettes

cigarettes with 0.12 nicotine yield with 2.4 mg/g nicotine content and 9.0 mg tar yield

Intervention Type OTHER

Normal Nicotine Content Cigarettes

cigarettes with 0.8 nicotine yield with 15.8 mg/g nicotine content and 10.5 mg tar yield

Intervention Type OTHER

Other Intervention Names

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Tobacco Cigarettes Tobacco Cigarettes Tobacco Cigarettes

Eligibility Criteria

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Inclusion Criteria

* generally healthy
* between the ages of 15-25
* use nicotine or tobacco products between 1-15 days/month for at least 6 months
* smokes at least 5 cigarettes/month
* no unstable or significant medical or psychiatric conditions
* breath alcohol value=0.000
* able to provide contact information for two individuals who can corroborate smoking status

Exclusion Criteria

* use of illegal drugs as measured by urine drug screen (excluding THC)
* serious quit attempt in the past 3 months
* plans to quit smoking in the next 2 months
* current use of nicotine replacement therapy or other tobacco cessation products
* inability to attend all required experimental sessions
* blood pressure \>160/100 mmHg
* pregnant, trying to become pregnant, or breastfeeding

Minimum Eligible Age

15 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes