Trial reportTobacco control2017
Reducing nicotine exposure results in weight gain in smokers randomised to very low nicotine content cigarettes.
Trial report in Tobacco control, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01681875 (Project 1, Study 1), which is not on this map. Cited by 14 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Project 1, Study 1: Investigating the Impact of Nicotine Using Spectrum Cigarettes
Who cites it
14 citing papers in PubMed, 2 syntheses or guidelines pooled it, 18 citations in OpenAlex.
- Regulatory Approaches and Implementation of Minimally Addictive Combusted Products.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2022Pooled it
- Nicotine Reduction in Cigarettes: Literature Review and Gap Analysis.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2019Pooled it
- Potential effects of nicotine content in cigarettes on use of other substances.Preventive medicine · 2022Trial
- Association of Reduced Nicotine Content Cigarettes With Smoking Behaviors and Biomarkers of Exposure Among Slow and Fast Nicotine Metabolizers: A Nonrandomized Clinical Trial.JAMA network open · 2018Trial
- Effects of reduced nicotine content cigarettes on individual withdrawal symptoms over time and during abstinence.Experimental and clinical psychopharmacology · 2018Trial
- Changes in weight among individuals with psychiatric conditions or socioeconomic disadvantage assigned to smoke very low nicotine content cigarettes.Experimental and clinical psychopharmacology · 2024Article
- Substitutability of nicotine and sucrose in rats: A behavioral economic analysis.Pharmacology, biochemistry, and behavior · 2023Article
- A review of the evidence on cigarettes with reduced addictiveness potential.The International journal on drug policy · 2022Review
- Tobacco harm reduction: Past history, current controversies and a proposed approach for the future.Preventive medicine · 2020Review
- A fully Bayesian mixture model approach for identifying noncompliance in a regulatory tobacco clinical trial.Statistics in medicine · 2020Article
- Effects of acute and chronic nicotine on catecholamine neurons of the nucleus of the solitary tract.American journal of physiology. Regulatory, integrative and comparative physiology · 2019Article
- Animal Research on Nicotine Reduction: Current Evidence and Research Gaps.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2017Article
- The life-course impact of smoking on hypertension, myocardial infarction and respiratory diseases.Scientific reports · 2017Article
- The Potential Impact of a Low Nicotine Product Standard for Cigarettes in Smokers Living With HIV.The Journal of the Association of Nurses in AIDS Care : JANACArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors at 11 institutions in 2 countries.
Funding
Abstract
backgroundThe Food and Drug Administration can reduce the nicotine content in cigarettes to very low levels. This potential regulatory action is hypothesised to improve public health by reducing smoking, but may have unintended consequences related to weight gain.
methodsWeight gain was evaluated from a double-blind, parallel, randomised clinical trial of 839 participants assigned to smoke 1 of 6 investigational cigarettes with nicotine content ranging from 0.4 to 15.8 mg/g or their own usual brand for 6 weeks. Additional analyses evaluated weight gain in the lowest nicotine content cigarette groups (0.4 and 0.4 mg/g, high tar) to examine the effect of study product in compliant participants as assessed by urinary biomarkers. Differences in outcomes due to gender were also explored.
findingsThere were no significant differences in weight gain when comparing the reduced nicotine conditions with the 15.8 mg/g control group across all treatment groups and weeks. However, weight gain at week 6 was negatively correlated with nicotine exposure in the 2 lowest nicotine content cigarette conditions. Within the 2 lowest nicotine content cigarette conditions, male and female smokers biochemically verified to be compliant on study product gained significantly more weight than non-compliant smokers and control groups.
conclusionsThe effect of random assignment to investigational cigarettes with reduced nicotine on weight gain was likely obscured by non-compliance with study product. Men and women who were compliant in the lowest nicotine content cigarette conditions gained 1.2 kg over 6 weeks, indicating weight gain is a likely consequence of reduced exposure to nicotine. TRIAL REGISTRATION NUMBER: NCT01681875, Post-results.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.