{"doi":"10.1001/jamanetworkopen.2022.41731","title":"Effect of Extending the Duration of Prequit Treatment With Varenicline on Smoking Abstinence","abstract":"Importance: Even with varenicline, the leading monotherapy for tobacco dependence, smoking abstinence rates remain low. Preliminary evidence suggests that extending the duration of varenicline treatment before quitting may increase abstinence. Objective: To test the hypotheses that, compared with standard run-in varenicline treatment (1 week before quitting), extended run-in varenicline treatment (4 weeks before quitting) reduces smoking exposure before the target quit date (TQD) and enhances abstinence, particularly among women. Design, Setting, and Participants: This double-blind, randomized, placebo-controlled clinical trial enrolled participants from October 2, 2017, to December 9, 2020, at a single-site research clinic in Buffalo, New York. Of 1385 people screened, 320 adults reporting smoking 5 or more cigarettes per day (CPD) were randomized and followed up for 28 weeks. Data were analyzed from August 2021 to June 2022. Interventions: In the pre-TQD period (weeks 1-4), the extended run-in group received 4 weeks of varenicline; the standard run-in group received 3 weeks of placebo followed by 1 week of varenicline. Both groups received open-label varenicline during weeks 5 to 15 and brief quit counseling at 6 clinic visits. Main Outcomes and Measures: The primary outcome consisted of cotinine-verified (at end of treatment [EOT]) self-reported continuous abstinence from smoking (in CPD) during the last 4 weeks of treatment. Secondary outcomes included bioverified self-report of continuous abstinence at the 6-month follow-up and percentage of reduction in self-reported smoking rate during the prequit period (week 1 vs week 4). Results: A total of 320 participants were randomized, including 179 women (55.9%) and 141 men (44.1%), with a mean (SD) age of 53.7 (10.1) years. Continuous abstinence during the final 4 weeks of treatment (weeks 12-15; EOT) was not greater in the extended run-in group (64 of 163 [39.3%]) compared with the standard run-in group (57 of 157 [36.3%]; odds ratio [OR], 1.13 [95% CI, 0.72-1.78]), nor was the hypothesized group × sex interaction significant (OR, 0.52 [95% CI, 0.21-1.28]). Similar nonsignificant results were obtained for continuous abstinence at the 6-month follow-up. The mean (SE) decrease in self-reported smoking rate during the prequit period was greater in the extended run-in group (-38.8% [2.8%]) compared with the standard run-in group (-17.5% [2.7%]). Conclusions and Relevance: Among adult daily smokers, extending the duration of prequit varenicline treatment beyond the standard 1-week run-in period reduced prequit smoking exposure but, more importantly, did not significantly improve continuous abstinence rates. Trial Registration: ClinicalTrials.gov Identifier: NCT03262662.","journal":"JAMA Network Open","year":2022,"id":277226,"datarank":0.3535278005842251,"base_score":2.1972245773362196,"endowment":2.1972245773362196,"self_citation_contribution":0.32958368660043297,"citation_network_contribution":0.02394411398379213,"self_endowment_contribution":0.32958368660043297,"citer_contribution":0.02394411398379213,"corpus_percentile":null,"corpus_rank":null,"citation_count":8,"citer_count":2,"citers_with_citation_signal":1,"citers_with_endowment":1,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9571,"is_data_producer":true,"deposit_databanks":{"ClinicalTrials.gov":["NCT03262662"]},"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2022-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":432638,"name":"Stephen T. Tiffany","orcid":"0000-0002-0735-1968","position":1,"is_corresponding":false},{"id":432636,"name":"Craig R. Colder","orcid":"0000-0002-6863-673X","position":2,"is_corresponding":false},{"id":420724,"name":"Rebecca L. Ashare","orcid":"0000-0003-4664-009X","position":3,"is_corresponding":false},{"id":948782,"name":"Jennifer M. Wray","orcid":null,"position":4,"is_corresponding":false},{"id":341217,"name":"Rachel F. Tyndale","orcid":"0000-0003-1297-2053","position":5,"is_corresponding":false},{"id":399204,"name":"Thomas H. Brandon","orcid":"0000-0003-1559-5679","position":6,"is_corresponding":false},{"id":432637,"name":"Martin C. Mahoney","orcid":"0000-0002-5069-1140","position":7,"is_corresponding":false},{"id":432639,"name":"Larry W. Hawk","orcid":"0000-0001-6593-9746","position":0,"is_corresponding":true}],"reference_count":54,"raw_metadata":null,"created_at":"2026-07-19T00:28:34.768552Z","pmid":"36367720","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":[]}