Project 2: Strategies for Reducing Nicotine Content in Cigarettes
2 other identifiers
interventional
1,250
1 country
10
Brief Summary
The main goal of this project is to compare two different approaches to reducing levels of nicotine in cigarettes: an immediate reduction in nicotine content in cigarettes to non-addictive levels or a gradual reduction in nicotine content in cigarettes to non-addictive levels. These two approaches will then be contrasted to a group that continues to smoke cigarettes with nicotine content similar to conventional cigarettes.
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 2014
Typical duration for not_applicable
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2014
CompletedFirst Posted
Study publicly available on registry
May 16, 2014
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 14, 2017
CompletedAugust 15, 2018
August 1, 2018
2.5 years
May 12, 2014
August 13, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Toxicant exposure pattern: Expired air carbon monoxide
Between group comparison of expired air carbon monoxide (CO) values at week 20 using baseline CO values as a covariate.
20-week treatment period
Toxicant exposure pattern: Urinary phenanthrene tetroal (Phe)
Between group comparison of urinary phenanthrene tetroal values at week 20 using baseline values as a covariate.
20-week treatment period
Toxicant exposure pattern: Urinary mercapturic acids of acrolein
Between group comparison of urinary mercapturic acid level at week 20 using baseline values as a covariate.
20-week treatment period
Secondary Outcomes (8)
Nicotine exposure: Total nicotine equivalents (TNE)
End of treatment (Week 20)
Other toxicant exposure: Tobacco specific nitrosamines-Total NNAL and NNN
End of treatment (Week 20)
Effect biomarker: C-Reactive protein-high sensitivity as an inflammation biomarker
End of treatment (Week 20)
Measure of acceptability: Retention in study
End of treatment (Week 20)
Measure of acceptability: Non-compliance
End of treatment (Week 20)
- +3 more secondary outcomes
Study Arms (3)
Normal Nicotine Control Group
ACTIVE COMPARATORThese subjects will smoke normal nicotine content Spectrum brand cigarettes for 20 weeks.
Immediate Nicotine Reduction Group
EXPERIMENTALThis group will immediately be switched to smoking very low nicotine content (VLNC) Spectrum brand cigarettes. They will smoke these cigarettes for 20 weeks.
Gradual Nicotine Reduction Group
EXPERIMENTALThis group will smoke progressively lower nicotine content Spectrum brand cigarettes for a period of one month each until they end up smoking the same VLNC cigarettes as the immediate reduction group.
Interventions
Participants will smoke experimental cigarettes for a period of 20-weeks.
Participants will smoke experimental cigarettes for a period of 20-weeks.
Participants will smoke experimental cigarettes for a period of 20-weeks.
Eligibility Criteria
You may qualify if:
- Age 18+
- Daily smokers who smoke an average of at least five cigarettes per day for at least 1 year
- Breath CO levels \> 8 ppm (if ≤ 8 ppm, then NicAlert Strip level must indicate regular smoking)
You may not qualify if:
- Planned quit date in the next 30 days
- Currently seeking treatment for smoking cessation
- Currently using nicotine replacement therapies or other pharmacotherapies as cessation aid (non-cessation intermittent use acceptable)
- A quit attempt in the past 30 days resulting in greater than 3 days of abstinence
- Using other tobacco products or e-cigarettes more than 9 days in the past 30 days
- Significant unstable medical conditions (Any significant change in a serious medical condition occurring during the past 3 months including, cardiovascular disease, COPD, and cancer, as determined by the licensed medical professional at each site)
- Unstable psychiatric conditions (Any significant change in psychiatric symptoms during the past 3 months as determined by the licensed medical professional at each site)
- Schizophrenia and schizoaffective disorder
- Psychiatric medication changes (e.g., new prescriptions, changes in dosages, or discontinuation of medications) in the past 3 months that was a result of negative changes in symptoms.
- Positive toxicology screen for any of the following drugs: cocaine, opiates, methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, and PCP
- Participants with valid prescriptions for opiates, benzodiazepines, barbiturates, amphetamines or methadone will not be excluded.
- Participants failing the toxicology screen will be allowed to re-screen once.
- Blood alcohol level \> 0.01
- a. Participants failing the blood alcohol screen will be allowed to re-screen once.
- Binge drinking alcohol (more than 9 days in the past 30 days, 4/5 drinks per day (female/male))
- +38 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Mayo Clinic
Phoenix, Arizona, 85054, United States
University of California San Francisco
San Francisco, California, 94143, United States
Moffitt Cancer Center
Tampa, Florida, 33617, United States
Johns Hopkins University
Baltimore, Maryland, 21224, United States
University of Minnesota Medical School Duluth
Duluth, Minnesota, 55812, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Duke University
Durham, North Carolina, 27705, United States
Oregon Research Institute
Eugene, Oregon, 97403, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
MDAnderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
Hatsukami DK, Luo X, Jensen JA, al'Absi M, Allen SS, Carmella SG, Chen M, Cinciripini PM, Denlinger-Apte R, Drobes DJ, Koopmeiners JS, Lane T, Le CT, Leischow S, Luo K, McClernon FJ, Murphy SE, Paiano V, Robinson JD, Severson H, Sipe C, Strasser AA, Strayer LG, Tang MK, Vandrey R, Hecht SS, Benowitz NL, Donny EC. Effect of Immediate vs Gradual Reduction in Nicotine Content of Cigarettes on Biomarkers of Smoke Exposure: A Randomized Clinical Trial. JAMA. 2018 Sep 4;320(9):880-891. doi: 10.1001/jama.2018.11473.
PMID: 30193275DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Donny, PhD
University of Pittsburgh
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2014
First Posted
May 16, 2014
Study Start
September 1, 2014
Primary Completion
March 1, 2017
Study Completion
March 14, 2017
Last Updated
August 15, 2018
Record last verified: 2018-08