Clinical trial NCT02989038: Reactions to Reduced Nicotine Cigarettes in Young Adult Low-Frequency Smokers
Official title: Reactions to Reduced Nicotine Cigarettes in Young Adult Low-Frequency Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nicotine Dependence
Keywords: smoker
young adult
adolescent
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2016-12-12
Enrollment: 182
Sex: ALL
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Subjective reactions to fixed doses of tobacco smoke
timeFrame: Immediately after puff administration of each study cigarette
measure: Cigarette choice
timeFrame: 30 minutes after sampling all 3 study cigarettes
Secondary outcomes:
measure: Mood and Affect
timeFrame: Immediately after puff administration of each study cigarette
measure: Mood and Affect
timeFrame: Immediately after puff administration of each study cigarette
measure: Smoking topography - Change in Carbon Monoxide (CO) values (in parts per million, ppm) following puff administration
timeFrame: Immediately after puff administration of each study cigarette
measure: Smoking topography - number of puffs
timeFrame: During self-administration of chosen cigarette at the last experimental session (approximately over 10 minutes)
measure: Smoking topography - interpuff interval
timeFrame: During self-administration of chosen cigarette at the last experimental session (approximately over 10 minutes)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Francis J McClernon, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: