Cytisinicline for Smoking Cessation: A Randomized Clinical Trial
IMPORTANCE: Cytisinicline (cytisine) is a plant-based alkaloid that, like varenicline, binds selectively to α4β2 nicotinic acetylcholine receptors, which mediate nicotine dependence. Although not licensed in the US, cytisinicline is used in some European countries to aid smoking cessation, but its t...
Published in: | JAMA |
---|---|
Main Authors: | , , , , , , , , |
Format: | Text |
Language: | English |
Published: |
American Medical Association
2023
|
Subjects: | |
Online Access: | http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10336611/ http://www.ncbi.nlm.nih.gov/pubmed/37432430 https://doi.org/10.1001/jama.2023.10042 |
id |
ftpubmed:oai:pubmedcentral.nih.gov:10336611 |
---|---|
record_format |
openpolar |
spelling |
ftpubmed:oai:pubmedcentral.nih.gov:10336611 2024-02-11T10:07:43+01:00 Cytisinicline for Smoking Cessation: A Randomized Clinical Trial Rigotti, Nancy A. Benowitz, Neal L. Prochaska, Judith Leischow, Scott Nides, Mitchell Blumenstein, Brent Clarke, Anthony Cain, Daniel Jacobs, Cindy 2023-07-11 http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10336611/ http://www.ncbi.nlm.nih.gov/pubmed/37432430 https://doi.org/10.1001/jama.2023.10042 en eng American Medical Association http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10336611/ http://www.ncbi.nlm.nih.gov/pubmed/37432430 http://dx.doi.org/10.1001/jama.2023.10042 Copyright 2023 American Medical Association. All Rights Reserved. JAMA Original Investigation Text 2023 ftpubmed https://doi.org/10.1001/jama.2023.10042 2024-01-14T01:41:39Z IMPORTANCE: Cytisinicline (cytisine) is a plant-based alkaloid that, like varenicline, binds selectively to α4β2 nicotinic acetylcholine receptors, which mediate nicotine dependence. Although not licensed in the US, cytisinicline is used in some European countries to aid smoking cessation, but its traditional dosing regimen and treatment duration may not be optimal. OBJECTIVE: To evaluate the efficacy and tolerability of cytisinicline for smoking cessation when administered in a novel pharmacokinetically based dosing regimen for 6 or 12 weeks vs placebo. DESIGN, SETTING, AND PARTICIPANTS: A 3-group, double-blind, placebo-controlled, randomized trial (ORCA-2) compared 2 durations of cytisinicline treatment (6 or 12 weeks) vs placebo, with follow-up to 24 weeks, among 810 adults who smoked cigarettes daily and wanted to quit. It was conducted at 17 US sites from October 2020 to December 2021. INTERVENTIONS: Participants were randomized (1:1:1) to cytisinicline, 3 mg, 3 times daily for 12 weeks (n = 270); cytisinicline, 3 mg, 3 times daily for 6 weeks then placebo 3 times daily for 6 weeks (n = 269); or placebo 3 times daily for 12 weeks (n = 271). All participants received behavioral support. MAIN OUTCOMES AND MEASURES: Biochemically verified continuous smoking abstinence for the last 4 weeks of cytisinicline treatment vs placebo (primary) and from end of treatment to 24 weeks (secondary). RESULTS: Of 810 randomized participants (mean age, 52.5 years; 54.6% female; mean of 19.4 cigarettes smoked daily), 618 (76.3%) completed the trial. For the 6-week course of cytisinicline vs placebo, continuous abstinence rates were 25.3% vs 4.4% during weeks 3 to 6 (odds ratio [OR], 8.0 [95% CI, 3.9-16.3]; P < .001) and 8.9% vs 2.6% during weeks 3 to 24 (OR, 3.7 [95% CI, 1.5-10.2]; P = .002). For the 12-week course of cytisinicline vs placebo, continuous abstinence rates were 32.6% vs 7.0% for weeks 9 to 12 (OR, 6.3 [95% CI, 3.7-11.6]; P < .001) and 21.1% vs 4.8% during weeks 9 to 24 (OR, 5.3 [95% CI, 2.8-11.1]; P < ... Text Orca PubMed Central (PMC) JAMA 330 2 152 |
institution |
Open Polar |
collection |
PubMed Central (PMC) |
op_collection_id |
ftpubmed |
language |
English |
topic |
Original Investigation |
spellingShingle |
Original Investigation Rigotti, Nancy A. Benowitz, Neal L. Prochaska, Judith Leischow, Scott Nides, Mitchell Blumenstein, Brent Clarke, Anthony Cain, Daniel Jacobs, Cindy Cytisinicline for Smoking Cessation: A Randomized Clinical Trial |
topic_facet |
Original Investigation |
description |
IMPORTANCE: Cytisinicline (cytisine) is a plant-based alkaloid that, like varenicline, binds selectively to α4β2 nicotinic acetylcholine receptors, which mediate nicotine dependence. Although not licensed in the US, cytisinicline is used in some European countries to aid smoking cessation, but its traditional dosing regimen and treatment duration may not be optimal. OBJECTIVE: To evaluate the efficacy and tolerability of cytisinicline for smoking cessation when administered in a novel pharmacokinetically based dosing regimen for 6 or 12 weeks vs placebo. DESIGN, SETTING, AND PARTICIPANTS: A 3-group, double-blind, placebo-controlled, randomized trial (ORCA-2) compared 2 durations of cytisinicline treatment (6 or 12 weeks) vs placebo, with follow-up to 24 weeks, among 810 adults who smoked cigarettes daily and wanted to quit. It was conducted at 17 US sites from October 2020 to December 2021. INTERVENTIONS: Participants were randomized (1:1:1) to cytisinicline, 3 mg, 3 times daily for 12 weeks (n = 270); cytisinicline, 3 mg, 3 times daily for 6 weeks then placebo 3 times daily for 6 weeks (n = 269); or placebo 3 times daily for 12 weeks (n = 271). All participants received behavioral support. MAIN OUTCOMES AND MEASURES: Biochemically verified continuous smoking abstinence for the last 4 weeks of cytisinicline treatment vs placebo (primary) and from end of treatment to 24 weeks (secondary). RESULTS: Of 810 randomized participants (mean age, 52.5 years; 54.6% female; mean of 19.4 cigarettes smoked daily), 618 (76.3%) completed the trial. For the 6-week course of cytisinicline vs placebo, continuous abstinence rates were 25.3% vs 4.4% during weeks 3 to 6 (odds ratio [OR], 8.0 [95% CI, 3.9-16.3]; P < .001) and 8.9% vs 2.6% during weeks 3 to 24 (OR, 3.7 [95% CI, 1.5-10.2]; P = .002). For the 12-week course of cytisinicline vs placebo, continuous abstinence rates were 32.6% vs 7.0% for weeks 9 to 12 (OR, 6.3 [95% CI, 3.7-11.6]; P < .001) and 21.1% vs 4.8% during weeks 9 to 24 (OR, 5.3 [95% CI, 2.8-11.1]; P < ... |
format |
Text |
author |
Rigotti, Nancy A. Benowitz, Neal L. Prochaska, Judith Leischow, Scott Nides, Mitchell Blumenstein, Brent Clarke, Anthony Cain, Daniel Jacobs, Cindy |
author_facet |
Rigotti, Nancy A. Benowitz, Neal L. Prochaska, Judith Leischow, Scott Nides, Mitchell Blumenstein, Brent Clarke, Anthony Cain, Daniel Jacobs, Cindy |
author_sort |
Rigotti, Nancy A. |
title |
Cytisinicline for Smoking Cessation: A Randomized Clinical Trial |
title_short |
Cytisinicline for Smoking Cessation: A Randomized Clinical Trial |
title_full |
Cytisinicline for Smoking Cessation: A Randomized Clinical Trial |
title_fullStr |
Cytisinicline for Smoking Cessation: A Randomized Clinical Trial |
title_full_unstemmed |
Cytisinicline for Smoking Cessation: A Randomized Clinical Trial |
title_sort |
cytisinicline for smoking cessation: a randomized clinical trial |
publisher |
American Medical Association |
publishDate |
2023 |
url |
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10336611/ http://www.ncbi.nlm.nih.gov/pubmed/37432430 https://doi.org/10.1001/jama.2023.10042 |
genre |
Orca |
genre_facet |
Orca |
op_source |
JAMA |
op_relation |
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10336611/ http://www.ncbi.nlm.nih.gov/pubmed/37432430 http://dx.doi.org/10.1001/jama.2023.10042 |
op_rights |
Copyright 2023 American Medical Association. All Rights Reserved. |
op_doi |
https://doi.org/10.1001/jama.2023.10042 |
container_title |
JAMA |
container_volume |
330 |
container_issue |
2 |
container_start_page |
152 |
_version_ |
1790606406460637184 |