Efficacy, Safety, and Economic Impact of Cytisinicline Maintenance Therapy in Patients Who Are Candidates for Smoking Cessation: Protocol for a Phase IV, Multicenter, Randomized, Open-Label, Controlled, Parallel Clinical Trial (CITISILONG Trial)
Notice bibliographique
Résumé
BACKGROUND: Cytisinicline has proven to be an effective, efficient, and safe molecule in smoking cessation. However, the established 25-day regimen could be insufficient in a high percentage of smokers, so it is necessary to study maintained therapies of this drug. OBJECTIVE: This study aims to compare the efficacy of the cytisinicline regimen used in routine clinical practice versus 2 maintained regimens of 50 and 75 days, respectively. In addition, the safety and economic impact of each regime will be determined. METHODS: A prospective, multicenter, open-label, controlled, parallel, phase IV clinical trial of 402 smoker patients prepared to quit smoking. The study was conducted in 10 hospitals in Spain. A control group is compared to 2 intervention groups in which the duration of the drug is increased without increasing its dose, administering half and all, respectively, of an additional marketed container that includes 100 tablets. Thus, participants will be randomized to three groups in a 1:1:1 ratio to receive cytisinicline: (1) a control group treated with cytisinicline according to the usual clinical guidelines and product information (25 days); (2) a group with a 50-day cytisinicline regimen (an additional 25 days at a dose of 1.5 mg every 12 hours), seeking to increase its efficacy while minimally impacting adherence; and (3) a group with a 75-day regimen (an additional 50 days at a dose of 1.5 mg every 12 hours), attempting to increase its efficacy, although the longer duration of the drug may threaten adherence. Efficacy in the 3 arms will be analyzed through sustained abstinence at 6 and 12 months, point abstinence rate assessed every 7 days, and abstinence rate from Day 25 to Day 50 and from Day 25 to Day 75 in the 3 study arms. (1) The variation in withdrawal and craving symptoms in the 3 groups, (2) safety through the percentage of adverse events in the 3 treatment arms, and (3) economic impact by evaluating the cost-effectiveness and cost-utility ratios of the 2 prolonged regimens versus the usual clinical cytisinicline regimen. To calculate the differences between the 3 groups for each outcome variable, a univariate analysis will be performed. Statistically significant variables will be included in a multivariate model. RESULTS: Recruitment for the trial and patient enrollment were completed in November 2026. Follow-up of all participants will extend to December 2027. CONCLUSIONS: In conclusion, this study evaluates the optimization of cytisinicline in daily clinical practice, increasing the benefits of its pharmaceutical properties without affecting patient safety. All of this will improve the effectiveness of smoking cessation by reducing the number of smokers, which implies lower morbidity and mortality and lower costs associated with smoking. TRIAL REGISTRATION: European Clinical Trials Register 2024-518936-36-00; https://euclinicaltrials.eu/ctis-public/view/2024-518936-36-00. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/76815.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,022 | 0,015 |
| Méta-épidémiologie (sens strict) | 0,004 | 0,001 |
| Méta-épidémiologie (sens large) | 0,006 | 0,004 |
| Bibliométrie | 0,002 | 0,002 |
| Études des sciences et des technologies | 0,002 | 0,003 |
| Communication savante | 0,002 | 0,002 |
| Science ouverte | 0,003 | 0,001 |
| Intégrité de la recherche | 0,005 | 0,006 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,031 | 0,007 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».