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

Study Overview
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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.

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.

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

Conditions
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Nicotine Dependence

Intervention / Treatment
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* Other: Very Low Nicotine Content Cigarettes
* Other: Intermediate Nicotine Content Cigarettes
* Other: Normal Nicotine Content Cigarettes


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NNC, INC, VLNC<br>Normal Nicotine Content (NNC), Intermediate Nicotine Content (INC), Very Low Nicotine Content (VLNC) | Other: Very Low Nicotine Content Cigarettes<br>* cigarettes with 0.03 nicotine yield with 0.4 mg/g nicotine content and 9.0 mg tar yield<br>* Other names: Cigarettes;Other: Intermediate Nicotine Content Cigarettes<br>* cigarettes with 0.12 nicotine yield with 2.4 mg/g nicotine content and 9.0 mg tar yield<br>* Other names: Cigarettes;Other: Normal Nicotine Content Cigarettes<br>* cigarettes with 0.8 nicotine yield with 15.8 mg/g nicotine content and 10.5 mg tar yield<br>* Other names: Cigarettes;|
| Experimental: NNC, VLNC, INC<br>Normal Nicotine Content, Very Low Nicotine Content, Intermediate Nicotine Content | Other: Very Low Nicotine Content Cigarettes<br>* cigarettes with 0.03 nicotine yield with 0.4 mg/g nicotine content and 9.0 mg tar yield<br>* Other names: Cigarettes;Other: Intermediate Nicotine Content Cigarettes<br>* cigarettes with 0.12 nicotine yield with 2.4 mg/g nicotine content and 9.0 mg tar yield<br>* Other names: Cigarettes;Other: Normal Nicotine Content Cigarettes<br>* cigarettes with 0.8 nicotine yield with 15.8 mg/g nicotine content and 10.5 mg tar yield<br>* Other names: Cigarettes;|
| Experimental: INC, VLNC, NNC<br>Intermediate Nicotine Content, Very Low Nicotine Content, Normal Nicotine Content | Other: Very Low Nicotine Content Cigarettes<br>* cigarettes with 0.03 nicotine yield with 0.4 mg/g nicotine content and 9.0 mg tar yield<br>* Other names: Cigarettes;Other: Intermediate Nicotine Content Cigarettes<br>* cigarettes with 0.12 nicotine yield with 2.4 mg/g nicotine content and 9.0 mg tar yield<br>* Other names: Cigarettes;Other: Normal Nicotine Content Cigarettes<br>* cigarettes with 0.8 nicotine yield with 15.8 mg/g nicotine content and 10.5 mg tar yield<br>* Other names: Cigarettes;|
| Experimental: INC, NNC, VLNC<br>Intermediate Nicotine Content, Normal Nicotine Content, Very Low Nicotine Content | Other: Very Low Nicotine Content Cigarettes<br>* cigarettes with 0.03 nicotine yield with 0.4 mg/g nicotine content and 9.0 mg tar yield<br>* Other names: Cigarettes;Other: Intermediate Nicotine Content Cigarettes<br>* cigarettes with 0.12 nicotine yield with 2.4 mg/g nicotine content and 9.0 mg tar yield<br>* Other names: Cigarettes;Other: Normal Nicotine Content Cigarettes<br>* cigarettes with 0.8 nicotine yield with 15.8 mg/g nicotine content and 10.5 mg tar yield<br>* Other names: Cigarettes;|
| Experimental: VLNC, NNC, INC<br>Very Low Nicotine Content, Normal Nicotine Content, Intermediate Nicotine Content | Other: Very Low Nicotine Content Cigarettes<br>* cigarettes with 0.03 nicotine yield with 0.4 mg/g nicotine content and 9.0 mg tar yield<br>* Other names: Cigarettes;Other: Intermediate Nicotine Content Cigarettes<br>* cigarettes with 0.12 nicotine yield with 2.4 mg/g nicotine content and 9.0 mg tar yield<br>* Other names: Cigarettes;Other: Normal Nicotine Content Cigarettes<br>* cigarettes with 0.8 nicotine yield with 15.8 mg/g nicotine content and 10.5 mg tar yield<br>* Other names: Cigarettes;|
| Experimental: VLNC, INC, NNC<br>Very Low Nicotine Content, Intermediate Nicotine Content, Normal Nicotine Content | Other: Very Low Nicotine Content Cigarettes<br>* cigarettes with 0.03 nicotine yield with 0.4 mg/g nicotine content and 9.0 mg tar yield<br>* Other names: Cigarettes;Other: Intermediate Nicotine Content Cigarettes<br>* cigarettes with 0.12 nicotine yield with 2.4 mg/g nicotine content and 9.0 mg tar yield<br>* Other names: Cigarettes;Other: Normal Nicotine Content Cigarettes<br>* cigarettes with 0.8 nicotine yield with 15.8 mg/g nicotine content and 10.5 mg tar yield<br>* Other names: Cigarettes;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective reactions to fixed doses of tobacco smoke | Smoking Effects Questionnaire ratings following administration of puffs for NNC, INC, and VLNC cigarettes | 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. | 30 minutes after sampling all 3 study cigarettes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mood and Affect | The Positive and Negative Affect Schedule (PANAS) | Immediately after puff administration of each study cigarette | 
| Mood and Affect | Minnesota Nicotine Withdrawal Scale (MNWS) | 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 | Immediately after puff administration of each study cigarette | 
| Smoking topography - number of puffs | number of puffs | During self-administration of chosen cigarette at the last experimental session (approximately over 10 minutes) | 
| Smoking topography - interpuff interval | Interpuff interval (in seconds) will be calculated using video recordings of self-administration of chosen cigarette | During self-administration of chosen cigarette at the last experimental session (approximately over 10 minutes) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoker, young adult, adolescent