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

Duke University182 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

182

Conditions

Nicotine Dependence

Interventions

Very Low Nicotine Content CigarettesOTHER

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

Intermediate Nicotine Content CigarettesOTHER

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

Normal Nicotine Content CigarettesOTHER

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

Eligibility

Sex: ALLMin age: 15 YearsMax age: 25 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Duke University Medical Center

Durham, North Carolina, United States

Outcomes

Primary Outcomes

Subjective reactions to fixed doses of tobacco smoke

Smoking Effects Questionnaire ratings following administration of puffs for NNC, INC, and VLNC cigarettes

Time frame: Immediately after puff administration of each study cigarette

Cigarette choice

Participants will choose which of the three cigarettes they prefer to smoke by ranking each of the three cigarette conditions using a 1-3 scale where 1 is the cigarette that they most desire to smoke and 3 is the cigarette that they least desire to smoke.

Time frame: 30 minutes after sampling all 3 study cigarettes

Secondary Outcomes

Mood and Affect

The Positive and Negative Affect Schedule (PANAS)

Time frame: Immediately after puff administration of each study cigarette

Mood and Affect

Minnesota Nicotine Withdrawal Scale (MNWS)

Time frame: Immediately after puff administration of each study cigarette

Smoking topography - Change in Carbon Monoxide (CO) values (in parts per million, ppm) following puff administration

CO values (in ppm) will be obtained using a handheld CO monitor prior to puff administration and 5 minutes after completion of cigarette puff administration. The difference in values will provide a CO boost value

Time frame: Immediately after puff administration of each study cigarette

Smoking topography - number of puffs

number of puffs

Time frame: During self-administration of chosen cigarette at the last experimental session (approximately over 10 minutes)

Data from ClinicalTrials.gov

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