{"doi":"10.1093/ntr/ntaa247","title":"Switching to Progressively Reduced Nicotine Content Cigarettes in Smokers With Low Socioeconomic Status: A Double-Blind Randomized Clinical Trial","abstract":"INTRODUCTION: The Food and Drug Administration issued an advanced notice of proposed rulemaking for setting a product standard for nicotine levels in cigarettes, with an emphasis on minimally or non-addicting very low nicotine content (VLNC). METHODS: A 33 week, two-arm, double-blind randomized trial conducted in Hershey, Pennsylvania, USA and Washington, DC, USA included adult daily cigarette smokers (≥5 cigarettes per day) with less than a college degree, and who had no plans to quit within the next six months. Participants were randomized to either reduced nicotine content (RNC) study cigarettes tapered every three weeks to a final VLNC (0.2 mg/cigarette) for six weeks or to usual nicotine content (UNC) study cigarettes (11.6 mg/cigarette). Outcomes included acceptability of study cigarettes measured by attrition (primary outcome), compliance, reduction in cigarette dependence and tobacco biomarkers, and post-intervention cessation. RESULTS: The RNC (n = 122) versus UNC (n = 123) group had higher attrition (adjusted Hazard Ratio 3.4; 95% confidence interval [CI] 1.99 to 5.81). At the end of the intervention, cotinine levels were 50% lower in the RNC group (mean group difference -137 ng/mL; 95% CI -172, -102). The RNC group smoked fewer CPD (-4.1; 95% CI -6.44, -1.75) and had lower carbon monoxide levels (-4.0 ppm; 95% CI -7.7, -0.4). Forty seven percent (29/62) of the RNC group were biochemically-confirmed compliant with smoking VLNC cigarettes (mean cotinine = 8.9 ng/ml). At three month follow-up, only compliant VLNC smokers quit with an assisted quit attempt (N = 6/22, 27%). CONCLUSIONS: This study supports a VLNC standard in cigarettes. IMPLICATIONS: Differential dropout and noncompliance indicate some smokers had difficulty transitioning to cigarettes with reduced nicotine. These smokers will benefit from supplemental nicotine in medicinal or noncombustible tobacco products if a nicotine reduction standard is established. Other smokers successfully transitioned to very low nicotine content cigarettes exclusively and substantially reduced their exposure to nicotine.","journal":"Nicotine & Tobacco Research","year":2020,"id":100355,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":29,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9564,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2020-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":432371,"name":"Junjia Zhu","orcid":"0000-0003-1311-3752","position":1,"is_corresponding":false},{"id":361478,"name":"Emily Wasserman","orcid":"0000-0003-3700-8375","position":2,"is_corresponding":false},{"id":492638,"name":"Robin Kuprewicz","orcid":"0000-0001-6264-8425","position":3,"is_corresponding":false},{"id":493297,"name":"Diane Martinez","orcid":null,"position":4,"is_corresponding":false},{"id":492639,"name":"Susan Veldheer","orcid":"0000-0001-6592-9249","position":5,"is_corresponding":false},{"id":492640,"name":"Craig Livelsberger","orcid":"0009-0004-6444-5102","position":6,"is_corresponding":false},{"id":493298,"name":"Jennifer Modesto","orcid":null,"position":7,"is_corresponding":false},{"id":492641,"name":"Lisa Reinhart","orcid":"0000-0001-6266-3342","position":8,"is_corresponding":false},{"id":493299,"name":"Neil Trushin","orcid":null,"position":9,"is_corresponding":false},{"id":432071,"name":"Samantha M. Reilly","orcid":"0000-0001-6855-5748","position":10,"is_corresponding":false},{"id":493300,"name":"Jason Liao","orcid":null,"position":11,"is_corresponding":false},{"id":493301,"name":"Alyse Fazzi","orcid":null,"position":12,"is_corresponding":false},{"id":283907,"name":"Rebecca Bascom","orcid":"0000-0001-5875-3476","position":13,"is_corresponding":false},{"id":490986,"name":"John P. Richie","orcid":"0000-0001-8239-2850","position":14,"is_corresponding":false},{"id":353597,"name":"Jonathan Foulds","orcid":"0000-0003-2296-0726","position":15,"is_corresponding":false},{"id":432372,"name":"Kimberly Horn","orcid":"0000-0002-8813-6265","position":16,"is_corresponding":false},{"id":265949,"name":"Joshua Muscat","orcid":"0000-0003-0867-423X","position":17,"is_corresponding":false},{"id":432370,"name":"Nicolle M. Krebs","orcid":"0000-0002-5824-4572","position":0,"is_corresponding":true}],"reference_count":41,"raw_metadata":null,"created_at":"2026-07-18T22:38:35.493878Z","pmid":"33249498","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}