A Multicenter, Double-blind, Randomized, Placebo-controlled Phase 2b Trial of Cytisinicline in Adult Smokers (The ORCA-1 Trial)
IntroductionCytisinicline (known as cytisine), a nicotinic acetylcholine receptor partial agonist, is a smoking cessation aid currently marketed in Central and Eastern Europe using a 1.5-mg/tablet 25-day downward titration schedule. No prior studies have evaluated other doses or administration sched...
Main Authors: | , , , , |
---|---|
Format: | Article in Journal/Newspaper |
Language: | unknown |
Published: |
eScholarship, University of California
2021
|
Subjects: | |
Online Access: | https://escholarship.org/uc/item/9gm5g4bw |
id |
ftcdlib:oai:escholarship.org:ark:/13030/qt9gm5g4bw |
---|---|
record_format |
openpolar |
spelling |
ftcdlib:oai:escholarship.org:ark:/13030/qt9gm5g4bw 2023-09-05T13:22:22+02:00 A Multicenter, Double-blind, Randomized, Placebo-controlled Phase 2b Trial of Cytisinicline in Adult Smokers (The ORCA-1 Trial) Nides, Mitchell Rigotti, Nancy A Benowitz, Neal Clarke, Anthony Jacobs, Cindy ntab073- 2021-08-29 application/pdf https://escholarship.org/uc/item/9gm5g4bw unknown eScholarship, University of California qt9gm5g4bw https://escholarship.org/uc/item/9gm5g4bw public Nicotine & Tobacco Research, vol 23, iss 10 Clinical Trials and Supportive Activities Tobacco Smoke and Health Neurosciences Prevention Clinical Research Tobacco Evaluation of treatments and therapeutic interventions 6.1 Pharmaceuticals Adult Alkaloids Azocines Benzazepines Double-Blind Method Humans Quinolizines Quinoxalines Smokers Treatment Outcome Varenicline Clinical Sciences Public Health and Health Services Marketing Public Health article 2021 ftcdlib 2023-08-21T18:04:56Z IntroductionCytisinicline (known as cytisine), a nicotinic acetylcholine receptor partial agonist, is a smoking cessation aid currently marketed in Central and Eastern Europe using a 1.5-mg/tablet 25-day downward titration schedule. No prior studies have evaluated other doses or administration schedules. This study evaluated the effects of a higher dosage and simplified dosing schedule on drug efficacy and tolerability.MethodsORCA-1 was a double-blind, randomized, placebo-controlled clinical trial that provided cytisinicline or placebo tablets plus behavioral support for 25 days. Adult smokers (>10 cigarettes daily) committed to quitting smoking were randomized to compare 2 cytisinicline doses (1.5 mg and 3 mg) versus placebo, and 2 administration schedules [downward titration versus 3 times daily (TID)]. Primary outcome was a reduction in expected cigarettes smoked at end of treatment; secondary outcomes were biochemically confirmed 7-day abstinence at Week 4 and continuous abstinence from Weeks 5 to 8.ResultsAmong 254 participants, those in cytisinicline arms (regardless of dose or schedule) had greater reductions in cigarettes smoked versus placebo, with differences observed in 3 cytisinicline arms statistically significant versus placebo. All cytisinicline arms had statistically significantly higher abstinence rates at Week 4 versus placebo. Both cytisinicline arms using TID schedules had statistically significantly higher continuous abstinence rates from Weeks 5 to 8 compared with placebo. Participants in the cytisinicline 3-mg TID arm had the highest abstinence rate. There were no safety concerns with either 1.5-mg or 3-mg cytisinicline.ConclusionBased on simpler dose scheduling, excellent tolerability, and best-continued abstinence rate, cytisinicline 3-mg TID was selected for future Phase 3 studies.ImplicationsAlthough the 1.5-mg 25-day titration schedule has been marketed in Central and Eastern Europe for decades, this study explored using a higher dosage and a simplified dosing schedule for impact ... Article in Journal/Newspaper Orca University of California: eScholarship |
institution |
Open Polar |
collection |
University of California: eScholarship |
op_collection_id |
ftcdlib |
language |
unknown |
topic |
Clinical Trials and Supportive Activities Tobacco Smoke and Health Neurosciences Prevention Clinical Research Tobacco Evaluation of treatments and therapeutic interventions 6.1 Pharmaceuticals Adult Alkaloids Azocines Benzazepines Double-Blind Method Humans Quinolizines Quinoxalines Smokers Treatment Outcome Varenicline Clinical Sciences Public Health and Health Services Marketing Public Health |
spellingShingle |
Clinical Trials and Supportive Activities Tobacco Smoke and Health Neurosciences Prevention Clinical Research Tobacco Evaluation of treatments and therapeutic interventions 6.1 Pharmaceuticals Adult Alkaloids Azocines Benzazepines Double-Blind Method Humans Quinolizines Quinoxalines Smokers Treatment Outcome Varenicline Clinical Sciences Public Health and Health Services Marketing Public Health Nides, Mitchell Rigotti, Nancy A Benowitz, Neal Clarke, Anthony Jacobs, Cindy A Multicenter, Double-blind, Randomized, Placebo-controlled Phase 2b Trial of Cytisinicline in Adult Smokers (The ORCA-1 Trial) |
topic_facet |
Clinical Trials and Supportive Activities Tobacco Smoke and Health Neurosciences Prevention Clinical Research Tobacco Evaluation of treatments and therapeutic interventions 6.1 Pharmaceuticals Adult Alkaloids Azocines Benzazepines Double-Blind Method Humans Quinolizines Quinoxalines Smokers Treatment Outcome Varenicline Clinical Sciences Public Health and Health Services Marketing Public Health |
description |
IntroductionCytisinicline (known as cytisine), a nicotinic acetylcholine receptor partial agonist, is a smoking cessation aid currently marketed in Central and Eastern Europe using a 1.5-mg/tablet 25-day downward titration schedule. No prior studies have evaluated other doses or administration schedules. This study evaluated the effects of a higher dosage and simplified dosing schedule on drug efficacy and tolerability.MethodsORCA-1 was a double-blind, randomized, placebo-controlled clinical trial that provided cytisinicline or placebo tablets plus behavioral support for 25 days. Adult smokers (>10 cigarettes daily) committed to quitting smoking were randomized to compare 2 cytisinicline doses (1.5 mg and 3 mg) versus placebo, and 2 administration schedules [downward titration versus 3 times daily (TID)]. Primary outcome was a reduction in expected cigarettes smoked at end of treatment; secondary outcomes were biochemically confirmed 7-day abstinence at Week 4 and continuous abstinence from Weeks 5 to 8.ResultsAmong 254 participants, those in cytisinicline arms (regardless of dose or schedule) had greater reductions in cigarettes smoked versus placebo, with differences observed in 3 cytisinicline arms statistically significant versus placebo. All cytisinicline arms had statistically significantly higher abstinence rates at Week 4 versus placebo. Both cytisinicline arms using TID schedules had statistically significantly higher continuous abstinence rates from Weeks 5 to 8 compared with placebo. Participants in the cytisinicline 3-mg TID arm had the highest abstinence rate. There were no safety concerns with either 1.5-mg or 3-mg cytisinicline.ConclusionBased on simpler dose scheduling, excellent tolerability, and best-continued abstinence rate, cytisinicline 3-mg TID was selected for future Phase 3 studies.ImplicationsAlthough the 1.5-mg 25-day titration schedule has been marketed in Central and Eastern Europe for decades, this study explored using a higher dosage and a simplified dosing schedule for impact ... |
format |
Article in Journal/Newspaper |
author |
Nides, Mitchell Rigotti, Nancy A Benowitz, Neal Clarke, Anthony Jacobs, Cindy |
author_facet |
Nides, Mitchell Rigotti, Nancy A Benowitz, Neal Clarke, Anthony Jacobs, Cindy |
author_sort |
Nides, Mitchell |
title |
A Multicenter, Double-blind, Randomized, Placebo-controlled Phase 2b Trial of Cytisinicline in Adult Smokers (The ORCA-1 Trial) |
title_short |
A Multicenter, Double-blind, Randomized, Placebo-controlled Phase 2b Trial of Cytisinicline in Adult Smokers (The ORCA-1 Trial) |
title_full |
A Multicenter, Double-blind, Randomized, Placebo-controlled Phase 2b Trial of Cytisinicline in Adult Smokers (The ORCA-1 Trial) |
title_fullStr |
A Multicenter, Double-blind, Randomized, Placebo-controlled Phase 2b Trial of Cytisinicline in Adult Smokers (The ORCA-1 Trial) |
title_full_unstemmed |
A Multicenter, Double-blind, Randomized, Placebo-controlled Phase 2b Trial of Cytisinicline in Adult Smokers (The ORCA-1 Trial) |
title_sort |
multicenter, double-blind, randomized, placebo-controlled phase 2b trial of cytisinicline in adult smokers (the orca-1 trial) |
publisher |
eScholarship, University of California |
publishDate |
2021 |
url |
https://escholarship.org/uc/item/9gm5g4bw |
op_coverage |
ntab073- |
genre |
Orca |
genre_facet |
Orca |
op_source |
Nicotine & Tobacco Research, vol 23, iss 10 |
op_relation |
qt9gm5g4bw https://escholarship.org/uc/item/9gm5g4bw |
op_rights |
public |
_version_ |
1776202898197184512 |