Clinical trial NCT03311646: Impact of Exclusive Use of Low Nicotine Cigarettes on Compensatory Smoking
Official title: Impact of Exclusive Use of Low Nicotine Cigarettes on Compensatory Smoking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2017-10-17
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants experienced an NNC phase (baseline) and a VLNC phase.
Primary purpose: OTHER

Brief summary: Smoking is the leading cause of preventable death in the United States. An FDA-mandated reduction in the nicotine content of cigarettes might reduce the health burden of tobacco by reducing the prevalence of smoking. The proposed project will test the impact of nicotine reduction on smoking behavior and smoke exposure in a setting where participants are restricted from using their usual brand cigarettes.

Detailed description: Smoking is the leading cause of preventable death in the United States. An FDA-mandated reduction in the nicotine content of cigarettes might reduce the health burden of tobacco by reducing the prevalence of smoking. The proposed project will test the impact of nicotine reduction on smoking behavior and smoke exposure in a setting where participants are restricted from using their usual brand cigarettes.Smokers will be confined to a hotel for two hotel stays (five days/ four nights each) during which they will only have access to the investigational cigarettes provided to them. The nicotine content of the investigational cigarettes may differ between the two weeks. Participants will enter the hotel in groups of 10 and everyone in a given stay will receive the same investigational cigarette. The first aim will assess measures of smoke and nicotine exposure including urinary cotinine and expired carbon monoxide. The second aim will assess behavioral measures of smoking including cigarettes smoked per day and puff topography.

Eligibility criteria: Inclusion Criteria:

* male or female participants who are least 18 years old and smoke daily
* willing to stay in a hotel for two four-night stays during the prearranged dates

Exclusion Criteria:

* unwilling to use research cigarettes as part of the trial
* pregnant, trying to become pregnant, or breastfeeding
* additional smoking and health criteria determined at screening

Primary outcomes:
measure: Breath Sample (Expired Carbon Monoxide)
timeFrame: 8am, 12pm, 4pm, 8pm beginning with 4pm on Day 1 and ending with 12pm on Day 5
measure: Average Cigarettes Smoked Per Day
timeFrame: Participants returned smoked cigarette butts each day at 12pm, creating four 24-hr samples for each hotel phase. Data reported here are for the four 24-hr samples of the VLNC condition.
Secondary outcomes:
measure: Minnesota Nicotine Withdrawal Scale
timeFrame: Participants complete this self-report questionnaire on Days 2-5 during the NNC (Baseline) and VLNC conditions. Presented here are the scores from the VLNC condition.
measure: Questionnaire of Smoking Urges
timeFrame: Participants complete the Questionnaire of Smoking Urges on Days 2-5 of both the NNC (baseline) and VLNC Condition. Data here are from the VLNC Condition.
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Tracy Smith, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smith TT, Koopmeiners JS, White CM, Denlinger-Apte RL, Pacek LR, De Jesus VR, Wang L, Watson C, Blount BC, Hatsukami DK, Benowitz NL, Donny EC, Carpenter MJ. The Impact of Exclusive Use of Very Low Nicotine Cigarettes on Compensatory Smoking: An Inpatient Crossover Clinical Trial. Cancer Epidemiol Biomarkers Prev. 2020 Apr;29(4):880-886. doi: 10.1158/1055-9965.EPI-19-0963. Epub 2020 Feb 26.