Nicotine Dependence
Conditions
Keywords
smoker, young adult, adolescent
Brief summary
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
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.
Interventions
cigarettes with 0.03 nicotine yield with 0.4 mg/g nicotine content and 9.0 mg tar yield
OTHERIntermediate Nicotine Content Cigarettes
cigarettes with 0.12 nicotine yield with 2.4 mg/g nicotine content and 9.0 mg tar yield
cigarettes with 0.8 nicotine yield with 15.8 mg/g nicotine content and 10.5 mg tar yield
Sponsors
National Institute on Drug Abuse (NIDA)
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
15 Years to 25 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective reactions to fixed doses of tobacco smoke | Immediately after puff administration of each study cigarette | Smoking Effects Questionnaire ratings following administration of puffs for NNC, INC, and VLNC cigarettes |
| Cigarette choice | 30 minutes after sampling all 3 study cigarettes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mood and Affect | Immediately after puff administration of each study cigarette | The Positive and Negative Affect Schedule (PANAS) |
| Smoking topography - Change in Carbon Monoxide (CO) values (in parts per million, ppm) following puff administration | Immediately after puff administration of each study cigarette | 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 |
| Smoking topography - number of puffs | During self-administration of chosen cigarette at the last experimental session (approximately over 10 minutes) | number of puffs |
| Smoking topography - interpuff interval | During self-administration of chosen cigarette at the last experimental session (approximately over 10 minutes) | Interpuff interval (in seconds) will be calculated using video recordings of self-administration of chosen cigarette |
Countries
United States
Outcome results
None listed