Cigarettes électroniques pour la réduction des méfaits chez les fumeurs atteints de maladie mentale grave
Amélioration de l'efficacité et de l'impact du counseling à l'aide de cigarettes électroniques pour la réduction des méfaits chez les personnes atteintes de maladie mentale grave
In this open-label, randomized controlled trial study, participants who smoke combustible cigarettes (CC) and are diagnosed with Serious Mental Illness (SMI) will be randomized in two arms to receive harm-reduction counseling and Ecological Momentary Intervention text messaging (EMI) along with either e-cigarettes (EC) or nicotine replacement therapy (NRT) such as patch and lozenges to compare the efficacy in CC smoking reduction.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Omar El-Shahawy
- Numéro de téléphone: 646-501-3587
- E-mail: Omar.ElShahawy@nyulangone.org
Sauvegarde des contacts de l'étude
- Nom: Noah Shedivy
- Numéro de téléphone: 507-424-9415
- E-mail: noah.shedivy@nyulangone.org
Lieux d'étude
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New York
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New York, New York, États-Unis, 10016
- Recrutement
- NYU Langone Health
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Currently smokes 5 or more CPD
- Willingness and ability to provide informed consent
- Age of at least 21 years
- Has SMI diagnosis (such as Schizophrenia, Schizoaffective disorders, Bipolar disorder, Depressive disorders, Trauma and stressor related disorders etc.) as determined using the MINI tool
- Interested in reducing CC smoking but not necessarily trying to quit
- Own a mobile phone or have regular access to a mobile phone
- Able to provide an additional contact to improve follow-up rates
Exclusion Criteria:
- Is pregnant or breastfeeding
- Used tobacco other than CC in the past 2 weeks (e.g., EC, cigarillo)
- Currently engaged in an attempt to quit CC
- Change in dose of their psychotropic medication(s) in the last 30 days
- Meeting DSM-V criteria for current alcohol or substance use disorder except for nicotine use disorder and active mild alcohol or substance use disorders.
- Past month suicidal ideation/suicide attempt and/or psychiatric hospitalization in the last 30 days
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: E-cigarettes (EC)
Adult cigarette smokers with a SMI diagnosis randomized to the EC arm will receive NRT including nicotine patches and lozenges. Participants will also receive telehealth motivational counseling during the intervention period of 8 weeks. |
Fixed dose. Participants are to use the EC as replacement for smoking combustible cigarettes. Participants will vape the EC.
Autres noms:
At baseline, after randomization, participants will receive their first telehealth session (20~25 minutes) from a counselor trained in motivational interviewing, harm reduction, and smoking cessation. Up to five additional sessions will be delivered, 15~20 minutes each. EMI can be defined as delivering tailored interventions via electronic messages (i.e., regular text messages) that include personalized feedback based on real-time assessment responses and other contextual factors. EMI will take place throughout the intervention period. |
|
Comparateur actif: Nicotine Replacement Therapy (NRT)
Adult cigarette smokers with a SMI diagnosis randomized to the NRT arm will receive NRT including nicotine patches and lozenges gum. Participants will also receive telehealth motivational counseling during the intervention period of 8 weeks. |
At baseline, after randomization, participants will receive their first telehealth session (20~25 minutes) from a counselor trained in motivational interviewing, harm reduction, and smoking cessation. Up to five additional sessions will be delivered, 15~20 minutes each. EMI can be defined as delivering tailored interventions via electronic messages (i.e., regular text messages) that include personalized feedback based on real-time assessment responses and other contextual factors. EMI will take place throughout the intervention period. Includes nicotine patches and lozenges. NRT use recommendations will follow the guidelines of the product, e.g. one patch per day. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Percentage of Participants who Achieve a 100% Reduction in Cigarettes Per Day (CPD) by Week 4
Délai: Up to Week 4
|
Measured via self-report (daily diary about smoking behavior) and verified by exhaled carbon-monoxide (eCO) level (< 6 ppm). |
Up to Week 4
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Percentage of Participants who Achieve a 100% Reduction in Cigarettes Per Day (CPD) by Week 8
Délai: Up to Week 8
|
Measured via self-report (daily diary about smoking behavior) and verified by exhaled carbon-monoxide (eCO) level (< 6 ppm). |
Up to Week 8
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Percentage of Participants who Achieve a 100% Reduction in Cigarettes Per Day (CPD) by Week 12
Délai: Up to Week 12
|
Measured via self-report (daily diary about smoking behavior) and verified by exhaled carbon-monoxide (eCO) level (< 6 ppm). |
Up to Week 12
|
|
Self-Reported Percent Change in CPD from Baseline to Week 8
Délai: Baseline, Week 8
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Measured via self-report (daily diary about smoking behavior). |
Baseline, Week 8
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Self-Reported Percent Change in CPD from Baseline to Week 12
Délai: Baseline, Week 12
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Measured via self-report (daily diary about smoking behavior). |
Baseline, Week 12
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Change in American Thoracic Questionnaire Score from Baseline to Week 12
Délai: Baseline, Week 12
|
8-item questionnaire assessing general thoracic pain. Items are rated on a Likert scale from 1 (never) to 5 (every day). The total score is the sum of responses and ranges from 8-40; higher scores indicate more severe impact of general thoracic pain. |
Baseline, Week 12
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Change in Symptom Check Questionnaire Score from Baseline to Week 12
Délai: Baseline, Week 12
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9-item assessment of chronic obstructive pulmonary disease (COPD) symptoms. Each item is marked as either "yes" or "no." The total score is the number of "yes" responses and ranges from 0-9; higher scores indicate more severe COPD symptoms. |
Baseline, Week 12
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Omar El-Shahawy, NYU Langone Health
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Comportement
- Fumeur
- Tabagisme
- Tabagisme
- Vapoter
- Tabagisme
- Réduction des méfaits
- Thérapeutique
- Pharmacothérapie
- Matériaux fabriqués
- Technologie, industrie et agriculture
- Dispositifs fumeurs
- Systèmes de livraison de nicotine électronique
- Thérapie de remplacement de la nicotine
- protéine localisée à l'interface des microfibrilles d'élastine
Autres numéros d'identification d'étude
- 23-00124
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request or for individual participant data meta-analysis beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data or researcher who provides a methodologically sound proposal executes a data use agreement with NYU Langone Health. Requests may be directed to: Omar.ElShahawy@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Délai de partage IPD
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Critères d'accès au partage IPD
The investigator who proposed to use the data or researchers who provide a methodologically sound proposal will be granted access upon reasonable request or for individual participant data meta-analysis. Requests should be directed to Omar.ElShahawy@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
Informations sur les médicaments et les dispositifs, documents d'étude
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