Impact of Very Low Nicotine Content Cigarettes in a Complex Marketplace
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|ClinicalTrials.gov Identifier: NCT03272685|
Recruitment Status : Recruiting
First Posted : September 5, 2017
Last Update Posted : October 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Tobacco Smoking Nicotine Dependence||Drug: Very Low Nicotine Content Cigarettes Drug: Normal Nicotine Content Cigarettes||Phase 3|
This randomized, open label, controlled, multi-site study will simulate a "real world" tobacco environment by providing participants access to an experimental marketplace where they will be given vouchers for a specified number of points that can be exchanged for study cigarettes (varying in nicotine content described below) and non-combusted tobacco/nicotine products (smokeless tobacco, snus, electronic cigarette, medicinal nicotine replacement) and at the end of the study can exchange unspent points for money.
Subjects (N=350 in each group) will be randomly assigned to: 1) very low nicotine content cigarettes (VLNC; 0.4 mg/g) along with non-combusted tobacco/nicotine products or 2) normal nicotine content cigarettes (NNC; 15.8 mg/g) along with non-combusted tobacco/nicotine products.
Smokers will undergo an orientation visit for screening and then enter a three phase experimental trial:
- Phase 1 - Baseline: Two week baseline assessment period during usual brand cigarette smoking.
- Phase 2 - Marketplace Adaptation: Two week period where subjects have access to the marketplace that provides their preferred usual brand cigarettes and selected non-combusted tobacco products to allow the subject to adjust to the marketplace prior to randomization;
- Phase 3 - Intervention: Randomization to a marketplace with access to either VLNC or NNC cigarettes plus non-combusted products for a 12 week period.
Biomarker samples are collected at baseline, end of Phase 2 and end of week Phase 3 (week 12).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||700 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Phase III randomized, open label, multi-center study that will examine the impact of very low nicotine content (VLNC) cigarettes using an experimental marketplace that contains tobacco and nicotine products, simulating a real world environment. There are three phases: Phase 1 is smoking usual brand cigarettes. Phase 2 is access to a marketplace with usual brand cigarettes and other non-combusted nicotine and tobacco products. Phase 3 involves access to a marketplace with study cigarettes and other non-combusted nicotine and tobacco products.|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Impact of Very Low Nicotine Content Cigarettes in a Complex Marketplace Part of "Evaluating New Nicotine Standards for Cigarettes"|
|Actual Study Start Date :||June 1, 2018|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2022|
Experimental: Very Low Nicotine Content Cigarettes
Very low nicotine content cigarettes (0.4 mg/g nicotine; 9 mg of tar)
Drug: Very Low Nicotine Content Cigarettes
0.4 mg/g nicotine; 9 mg tar
Other Name: Reduced Nicotine Content Cigarettes
Active Comparator: Normal Nicotine Content Cigarettes
Normal (Conventional) Nicotine Content (15.8 mg/g nicotine; 9 mg of tar)
Drug: Normal Nicotine Content Cigarettes
15.8 mg/g nicotine; 9 mg tar
Other Name: Conventional Nicotine Content Cigarettes
- Cigarettes Per Day (CPD) [ Time Frame: 7 days prior to end of Phase 2 and the end of Week 12 (12 weeks on study cigarettes) ]The mean cigarettes (study and non-study cigarettes) smoked per day based on 7 days Daily Interactive Voice Response (IVR) data at the end of Phase 3 (experimental marketplace with study cigarettes) compared to Phase 2 (experimental marketplace with usual brand cigarettes).
- Cigarette-free Days [ Time Frame: 12 weeks on study cigarettes ]Rate of cigarette-free days, defined as no cigarettes smoked in the past 24 hours calculated as the proportion of cigarette-free days out of the total number of days in Phase 3.
- Percent Change in Total Nicotine Equivalents (TNE) [ Time Frame: 12 weeks (Phase 3) on study cigarettes ]Percent change in TNE, measure of nicotine and it's metabolites, from the end of Phase 2 (experimental marketplace with usual brand cigarettes) to end of Phase 3 (experimental marketplace with study cigarettes).
- Percent Change in 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (total NNAL) [ Time Frame: 12 weeks (Phase 3) on study cigarettes ]Change in total NNAL pmol/mg creatinine, (a measure of the exposure to NNK, a tobacco specific nitrosamine) from the end of Phase 2 (experimental marketplace with usual brand cigarettes) to end of Phase 3 (experimental marketplace with study cigarettes).
- Percent Change in 2-cyanoethyl-mercapturic Acid (CEMA) [ Time Frame: 12 weeks (Phase 3) on study cigarettes ]Change in CEMA (biomarker for the mercapturic acid acrolonitrile) from end of Phase 2 (experimental marketplace with usual brand cigarettes) to end of Phase 3 (experimental marketplace with study cigarettes).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03272685
|Contact: Lori Strayer, MSfirstname.lastname@example.org|
|Contact: Joni Jensen, MPHemail@example.com|
|United States, California|
|Tobacco Research Center||Recruiting|
|San Francisco, California, United States, 94110|
|Contact: Natalie Program Manager, PhD 415-514-1450 Natalie.Nardone@ucsf.edu|
|Contact: Jennifer Coordinator 514 KoJ@medsfgh.ucsf.edu|
|Principal Investigator: Neal Benowitz, MD|
|United States, Minnesota|
|Tobacco Research Programs||Recruiting|
|Minneapolis, Minnesota, United States, 55414|
|Contact: Joni Jensen, MPH 612-624-5178 firstname.lastname@example.org|
|Contact: Laura Coordinator 612-623422 email@example.com|
|Principal Investigator: Dorothy Hatsukami, PhD|
|United States, North Carolina|
|Durham, North Carolina, United States, 27705|
|Contact: Rachel Program Manager 919-668-2963 Rachel.firstname.lastname@example.org|
|Contact: Alicia Coordinator Alicia.email@example.com|
|Principal Investigator: F J McClernon, PhD|
|Principal Investigator:||Dorothy Hatsukami, PHD||University of Minnesota - Clinical and Translational Science Institute|