{"doi":"10.1093/ntr/ntae172","title":"Varenicline Over-The-Counter Trial on Efficacy and Safety","abstract":"INTRODUCTION: Varenicline helps people who smoke quit at rates 2-3 times greater than placebo. Currently, in the United States, varenicline is not available over the counter (OTC). AIMS AND METHODS: In this study, we assessed the safety and efficacy of 1 mg and 0.5 mg varenicline as an OTC medication for smoking cessation in comparison to placebo. This randomized, double-blind, placebo-controlled study was performed at two clinical sites in the United States of n = 313 people. The treatment period was 12 weeks. During the COVID pandemic, the protocol was modified to allow remote participation; verification of smoking status was via breath carbon monoxide levels for in-person visits and mailed urine cotinine kits for the remote participants. RESULTS: There was no difference in biologically confirmed continuous abstinence by condition between weeks 8 and 12; however, the odds of biologically confirmed point prevalence abstinence were higher for those in the 1 mg b.i.d. condition than for those in the placebo condition at week 12 (OR 3.39; 95% CI 1.49, 7.71), and were higher for those assigned to the 1.0 mg b.i.d. condition than the 0.5 mg b.i.d. condition at week 12 (OR 2.37; 95% CI 1.11, 5.05). Adverse events were modest, and as expected (vivid dreams and nausea in the medication conditions). CONCLUSIONS: The results are suggestive that varenicline is safe and effective as an OTC medication.","journal":"Nicotine & Tobacco Research","year":2024,"id":461161,"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":3,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9521,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2024-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":1290129,"name":"Mitchell Nides","orcid":null,"position":1,"is_corresponding":false},{"id":1290130,"name":"Alana Cataldo","orcid":null,"position":2,"is_corresponding":false},{"id":1290131,"name":"Marisol Martinez","orcid":null,"position":3,"is_corresponding":false},{"id":1290132,"name":"Jackie Morales","orcid":null,"position":4,"is_corresponding":false},{"id":1289689,"name":"Ryan Seltzer","orcid":"0000-0002-9287-448X","position":5,"is_corresponding":false},{"id":451846,"name":"Jonathan Kurka","orcid":"0000-0002-9086-9564","position":6,"is_corresponding":false},{"id":1128409,"name":"Matthew Broussard","orcid":null,"position":7,"is_corresponding":false},{"id":406690,"name":"Scott J. Leischow","orcid":"0000-0002-5804-3543","position":8,"is_corresponding":false},{"id":423518,"name":"Jennifer Pearson","orcid":"0000-0002-1400-5932","position":0,"is_corresponding":true}],"reference_count":32,"raw_metadata":null,"created_at":"2026-07-19T02:04:12.271488Z","pmid":"39012011","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":[]}