Cigarrillos electrónicos para la reducción de daños entre fumadores con enfermedades mentales graves
Eficacia e impacto de la consejería mejorada mediante el uso de cigarrillos electrónicos para la reducción de daños en personas con enfermedades mentales graves
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.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Omar El-Shahawy
- Número de teléfono: 646-501-3587
- Correo electrónico: Omar.ElShahawy@nyulangone.org
Copia de seguridad de contactos de estudio
- Nombre: Noah Shedivy
- Número de teléfono: 507-424-9415
- Correo electrónico: noah.shedivy@nyulangone.org
Ubicaciones de estudio
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New York
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New York, New York, Estados Unidos, 10016
- Reclutamiento
- NYU Langone Health
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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.
Otros nombres:
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. |
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Comparador activo: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Percentage of Participants who Achieve a 100% Reduction in Cigarettes Per Day (CPD) by Week 4
Periodo de tiempo: Up to Week 4
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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
Periodo de tiempo: Up to Week 8
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Measured via self-report (daily diary about smoking behavior) and verified by exhaled carbon-monoxide (eCO) level (< 6 ppm). |
Up to Week 8
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Percentage of Participants who Achieve a 100% Reduction in Cigarettes Per Day (CPD) by Week 12
Periodo de tiempo: Up to Week 12
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Measured via self-report (daily diary about smoking behavior) and verified by exhaled carbon-monoxide (eCO) level (< 6 ppm). |
Up to Week 12
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Self-Reported Percent Change in CPD from Baseline to Week 8
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Omar El-Shahawy, NYU Langone Health
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Comportamiento
- De fumar
- Tabaquismo
- El consumo de tabaco
- Vapear
- Fumar cigarrillos
- Reducción de daños
- Terapéutica
- Terapia con drogas
- Materiales manufacturados
- Tecnología, industria y agricultura
- Dispositivos para fumar
- Sistemas electrónicos de entrega de nicotina
- Terapia de reemplazo de nicotina
- proteína localizada en la interfaz de microfibrillas de elastina
Otros números de identificación del estudio
- 23-00124
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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.
Marco de tiempo para compartir IPD
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Criterios de acceso compartido de 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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