Reduced Nicotine Content Cigarettes in Smokers of Lower Socioeconomic Status
2 other identifiers
interventional
280
1 country
2
Brief Summary
The overall goal of this study is to address the question of whether progressively lowering nicotine content in cigarettes can reduce or eliminate nicotine dependence in smokers of low socioeconomic status
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2015
Typical duration for not_applicable
2 active sites
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
August 21, 2013
CompletedFirst Posted
Study publicly available on registry
August 27, 2013
CompletedStudy Start
First participant enrolled
September 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 5, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 23, 2018
CompletedResults Posted
Study results publicly available
March 12, 2019
CompletedMay 1, 2019
April 1, 2019
2.3 years
August 21, 2013
January 4, 2019
April 16, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Who Dropped Out of Study as a Measure of Adherence
Adherence to the regimen was assessed via dropout (due to withdrawal or lost-to-follow up) during the randomized intervention trial phase of the study. Dropout was analyzed as a time-to-event outcome during the 18 weeks after randomization.
18 weeks
Secondary Outcomes (6)
Predictors of Participant Dropout
18 weeks
Cigarettes Per Day
18 weeks
Nicotine Exposure
18 weeks
Smoke Exposure
18 weeks
Perceived Stress
18 weeks
- +1 more secondary outcomes
Study Arms (2)
Reduced Nicotine Content Cigarettes
EXPERIMENTALthe experimental group will smoke cigarettes with Gradually Reduced Nicotine Content (RNC) (11.6, 7.4, 3.3, 1.4, 0.7, and 0.2 mg per cigarette) cigarettes, each smoked for 3 weeks, except for the last period which will last 6 weeks to evaluate a longer-term adherence to the lowest nicotine content cigarette.
Same Nicotine Content Cigarettes
PLACEBO COMPARATORThe Same Nicotine Control Group (SNC) will continue to smoke research cigarettes with a usual nicotine content (about 11.6 mg per cigarette)
Interventions
Cigarettes contain 11.6, 7.4, 3.3, 1.4, 0.7, and 0.2 mg nicotine per cigarette
about 11.6 mg nicotine per cigarette
Eligibility Criteria
You may qualify if:
- Age 18-65
- Less than 16 years of education
- Able to understand, and sign consent
- Smoke \>4 cigarettes/day for at least a year
- No quit attempt in prior 1 month and not planning to quit smoking within next 6 months
- Plan to live in local area for next 8 months
- Able to read and write in English
- Women not pregnant and taking steps to avoid pregnancy
You may not qualify if:
- College graduate
- Use of psychotropic drugs
- Significant medical condition, or immune system disorders, respiratory diseases, kidney or liver diseases or any other medical disorders that may affect biomarker data
- Use of any non-cigarette nicotine delivery product in the past week or smoking cessation medicine in prior 3 months
- Currently pregnant or nursing
- Uncontrolled serious psychotic illness or substance abuse
- History of difficulties providing blood samples-fainting, poor veins, anxiety
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Milton S. Hershey Medical Centerlead
- George Washington Universitycollaborator
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (2)
George Washington University School of Public Health
Washington D.C., District of Columbia, 20052, United States
Penn State College of Medicine
Hershey, Pennsylvania, 17033, United States
Related Publications (1)
Krebs NM, Allen SI, Veldheer S, Martinez DJ, Horn K, Livelsberger C, Modesto J, Kuprewicz R, Wilhelm A, Hrabovsky S, Kazi A, Fazzi A, Liao J, Zhu J, Wasserman E, Reilly SM, Reinhart L, Trushin N, Moyer RE, Bascom R, Foulds J, Richie JP Jr, Muscat JE. Reduced nicotine content cigarettes in smokers of low socioeconomic status: study protocol for a randomized control trial. Trials. 2017 Jul 3;18(1):300. doi: 10.1186/s13063-017-2038-9.
PMID: 28673312DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The sample size was not reached due to a shortage of study cigarette inventory.
Results Point of Contact
- Title
- Nicolle Krebs
- Organization
- Penn State College of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Joshua Muscat, PhD
Penn State College of Medicine
- STUDY DIRECTOR
Kimberly Horn, PhD
George Washington University School of Public Health
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 21, 2013
First Posted
August 27, 2013
Study Start
September 9, 2015
Primary Completion
January 5, 2018
Study Completion
February 23, 2018
Last Updated
May 1, 2019
Results First Posted
March 12, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share