Reactions to Reduced Nicotine Cigarettes in Young Adult Low-Frequency Smokers
NicRed
2 other identifiers
interventional
182
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 23, 2016
CompletedFirst Posted
Study publicly available on registry
December 12, 2016
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 22, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 17, 2019
CompletedMarch 4, 2020
February 1, 2020
2.8 years
September 23, 2016
March 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (5)
Mood and Affect
Immediately after puff administration of each study cigarette
Mood and Affect
Immediately after puff administration of each study cigarette
Smoking topography - Change in Carbon Monoxide (CO) values (in parts per million, ppm) following puff administration
Immediately after puff administration of each study cigarette
Smoking topography - number of puffs
During self-administration of chosen cigarette at the last experimental session (approximately over 10 minutes)
Smoking topography - interpuff interval
During self-administration of chosen cigarette at the last experimental session (approximately over 10 minutes)
Study Arms (6)
NNC, INC, VLNC
EXPERIMENTALNormal Nicotine Content (NNC), Intermediate Nicotine Content (INC), Very Low Nicotine Content (VLNC)
NNC, VLNC, INC
EXPERIMENTALNormal Nicotine Content, Very Low Nicotine Content, Intermediate Nicotine Content
INC, VLNC, NNC
EXPERIMENTALIntermediate Nicotine Content, Very Low Nicotine Content, Normal Nicotine Content
INC, NNC, VLNC
EXPERIMENTALIntermediate Nicotine Content, Normal Nicotine Content, Very Low Nicotine Content
VLNC, NNC, INC
EXPERIMENTALVery Low Nicotine Content, Normal Nicotine Content, Intermediate Nicotine Content
VLNC, INC, NNC
EXPERIMENTALVery Low Nicotine Content, Intermediate Nicotine Content, Normal Nicotine Content
Interventions
cigarettes with 0.03 nicotine yield with 0.4 mg/g nicotine content and 9.0 mg tar yield
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (1)
Duke University Medical Center
Durham, North Carolina, 27705, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Francis J McClernon, Ph.D.
Duke University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2016
First Posted
December 12, 2016
Study Start
January 1, 2017
Primary Completion
October 22, 2019
Study Completion
December 17, 2019
Last Updated
March 4, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share