Reactions to Reduced Nicotine Cigarettes in Young Adult Low-Frequency Smokers
- Conditions
- Nicotine Dependence
- Interventions
- Other: Very Low Nicotine Content CigarettesOther: Intermediate Nicotine Content CigarettesOther: Normal Nicotine Content Cigarettes
- Registration Number
- NCT02989038
- Lead Sponsor
- Duke University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 182
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description VLNC, INC, NNC Intermediate Nicotine Content Cigarettes Very Low Nicotine Content, Intermediate Nicotine Content, Normal Nicotine Content NNC, INC, VLNC Intermediate Nicotine Content Cigarettes Normal Nicotine Content (NNC), Intermediate Nicotine Content (INC), Very Low Nicotine Content (VLNC) NNC, INC, VLNC Normal Nicotine Content Cigarettes Normal Nicotine Content (NNC), Intermediate Nicotine Content (INC), Very Low Nicotine Content (VLNC) NNC, INC, VLNC Very Low Nicotine Content Cigarettes Normal Nicotine Content (NNC), Intermediate Nicotine Content (INC), Very Low Nicotine Content (VLNC) NNC, VLNC, INC Very Low Nicotine Content Cigarettes Normal Nicotine Content, Very Low Nicotine Content, Intermediate Nicotine Content NNC, VLNC, INC Normal Nicotine Content Cigarettes Normal Nicotine Content, Very Low Nicotine Content, Intermediate Nicotine Content INC, VLNC, NNC Very Low Nicotine Content Cigarettes Intermediate Nicotine Content, Very Low Nicotine Content, Normal Nicotine Content NNC, VLNC, INC Intermediate Nicotine Content Cigarettes Normal Nicotine Content, Very Low Nicotine Content, Intermediate Nicotine Content INC, NNC, VLNC Very Low Nicotine Content Cigarettes Intermediate Nicotine Content, Normal Nicotine Content, Very Low Nicotine Content VLNC, NNC, INC Normal Nicotine Content Cigarettes Very Low Nicotine Content, Normal Nicotine Content, Intermediate Nicotine Content VLNC, INC, NNC Very Low Nicotine Content Cigarettes Very Low Nicotine Content, Intermediate Nicotine Content, Normal Nicotine Content INC, VLNC, NNC Intermediate Nicotine Content Cigarettes Intermediate Nicotine Content, Very Low Nicotine Content, Normal Nicotine Content INC, NNC, VLNC Intermediate Nicotine Content Cigarettes Intermediate Nicotine Content, Normal Nicotine Content, Very Low Nicotine Content INC, NNC, VLNC Normal Nicotine Content Cigarettes Intermediate Nicotine Content, Normal Nicotine Content, Very Low Nicotine Content INC, VLNC, NNC Normal Nicotine Content Cigarettes Intermediate Nicotine Content, Very Low Nicotine Content, Normal Nicotine Content VLNC, NNC, INC Very Low Nicotine Content Cigarettes Very Low Nicotine Content, Normal Nicotine Content, Intermediate Nicotine Content VLNC, NNC, INC Intermediate Nicotine Content Cigarettes Very Low Nicotine Content, Normal Nicotine Content, Intermediate Nicotine Content VLNC, INC, NNC Normal Nicotine Content Cigarettes Very Low Nicotine Content, Intermediate Nicotine Content, Normal Nicotine Content
- Primary Outcome Measures
Name Time Method 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.
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
- Secondary Outcome Measures
Name Time Method Mood and Affect Immediately after puff administration of each study cigarette Minnesota Nicotine Withdrawal Scale (MNWS)
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 - 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
Smoking topography - number of puffs During self-administration of chosen cigarette at the last experimental session (approximately over 10 minutes) number of puffs
Trial Locations
- Locations (1)
Duke University Medical Center
🇺🇸Durham, North Carolina, United States