Evaluating an Innovative Tobacco Treatment Approach for Veterans in Substance Use Treatment (Co-STOP)
9 de septiembre de 2026 actualizado por: VA Office of Research and Development
Evaluating an Innovative Tobacco Treatment Approach for Veterans in Substance Use Disorder Treatment
Veterans with substance use disorders smoke at extraordinarily high rates and have high rates of smoking-related death and disease.
It is essential to provide tobacco treatment for Veterans with substance use disorders, but there are unfortunately low rates of smoking treatment engagement within the VA for those with substance use disorders.
The goal of this project is to generate preliminary evidence for a smoking intervention program called "Concurrent Substance and Tobacco Outpatient Program" or Co-STOP.
Co-STOP aims to increase tobacco treatment use and effectiveness for Veterans in outpatient substance use treatment.
The investigators hypothesize that Co-STOP, relative to standard tobacco treatment, will increase tobacco treatment use and quit attempts.
This research will help the VA develop effective strategies to promote smoking treatment use and abstinence in Veterans with substance use disorders who smoke, thereby improving rates of morbidity and mortality in Veterans with substance use disorders.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Descripción detallada
This project will generate knowledge about strategies to increase smoking treatment engagement in Veterans with substance use disorders, a group that suffers disproportionately from smoking-related disease and death. This project will This project will evaluate the acceptability, feasibility, and preliminary efficacy of the Co-STOP program relative to standard cessation treatment offered at the VA. Co-STOP is an intervention designed to make tobacco treatment part of routine care for Veterans in substance use treatment and thereby enhance tobacco treatment use and quit attempts. Co-STOP offers evidence-based counseling and nicotine replacement therapy for smoking cessation as well as smoking reduction or changes if Veterans are not willing to quit. In Co-STOP, treatment is provided unless the Veteran declines, and makes tobacco treatment the default during substance use treatment. It is expected that Enhanced Chronic Care will increase treatment use and smoking abstinence relative to Standard Care.
This project will randomize N=112 Veterans receiving VA outpatient SUD care who smoke daily in a 1:1 ratio to Co-STOP or SC in a pilot randomized controlled trial (RCT). Co-STOP participants will be informed that they will be provided with evidence-based smoking treatment, which does not require a commitment to quit, as part of their SUD care, unless they opt-out. Co-STOP participants who do not opt out will receive 4 months of nicotine replacement therapy (NRT) and five behavioral counseling calls to support making 'healthy changes' or quitting smoking. SC participants will be offered entry into standard VA cessation treatment. Outcomes will be assessed over 4-months post-study entry. The investigators hypothesize that relative to SC, Co-STOP will increase smoking treatment use (i.e., use of NRT + counseling) and the likelihood of making a quit attempt.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
112
Fase
- Fase 4
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Jessica M Cook, PhD
- Número de teléfono: (608) 256-1901
- Correo electrónico: Jessica.Cook2@va.gov
Copia de seguridad de contactos de estudio
- Nombre: Jennifer M Betts, PhD
- Número de teléfono: (608) 280-7084
- Correo electrónico: jennifer.betts@va.gov
Ubicaciones de estudio
-
-
Wisconsin
-
Madison, Wisconsin, Estados Unidos, 53705-2254
- William S. Middleton Memorial Veterans Hospital, Madison, WI
-
Contacto:
- Elana G Brubaker, MSW BS
- Número de teléfono: 17854 (608) 256-1901
- Correo electrónico: elana.brubaker@va.gov
-
Investigador principal:
- Jennifer M. Betts, PhD
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Smoke at least one cigarette per day
- Be engaged in VA outpatient substance use treatment for at least one month
- Be medically eligible to use Nicotine Replacement Therapy (NRT)
- Not currently receiving smoking treatment
- Not currently at high risk for suicide
- Have an email address
Exclusion Criteria:
- Unable to give informed, voluntary consent to participate
- Incarceration
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Co-STOP
Co-STOP participants will receive evidence-based smoking treatment, that does not require a commitment to quit, as routine part of their SUD care unless they decline treatment.
This will include 4 months of counseling and NRT to support the smoking change goal on which they would like to work.
All participants in the Co-STOP condition will receive Healthy Changes treatment, which focuses on making manageable changes to smoking, unless they choose to make a quit attempt (or decline treatment).
If they choose to make a quit attempt, they will receive Cessation Treatment.
|
All participants in Co-STOP will receive their choice of nicotine mini-lozenge or gum for 4 months, unless they decline or start Cessation Treatment instead.
If <30 min to first cigarette of the day then 4mg mini-lozenges/gum will be prescribed, and if ≥30 min to first cigarette of the day then 2-mg mini-lozenges/gum will be prescribed.
Participants will be encouraged to use NRT in place of smoking (5-15 pieces/day).
Otros nombres:
If a participant enters Cessation Treatment, they will receive combination NRT (patch with participant choice of mini-lozenge or gum).
Nicotine patch dosing, which will begin on the TQD, will be will be consistent with medication labeling; i.e., if smoking >10 cigarettes/day= starting at 21-mg; if smoking ≤10 cigarettes/day = starting at 14-mg nicotine patches.
Similarly, dosing for nicotine mini-lozenge/gum: <30 min to 1st cig/day starting at 4mg every 1-2 hours; if ≥30 min to 1st cig/day, then starting at 2mg every 1-2 hours.
Otros nombres:
All participants who enter cessation treatment will receive five, 15-20 minute counseling calls over 16 weeks.
Calls will be scheduled at approximately 1-week pre-target quit day (TQD), 1-day post TQD, and three flexible sessions up to week 16.
Prior to quitting, the study counselor will reinforce reasons for quitting, discuss past quit experiences, and develop a quit day plan.
Post-quit sessions will include coping with cravings, identifying high-risk situations (e.g., co-use with other substances), developing behavioral plans for high-risk situations, and a plan to manage a lapse/relapse.
All participants in Co-STOP will receive counseling calls for Healthy Changes Counseling unless they choose to enter Cessation Treatment or decline.
Participants will receive five, 15-20 minute counseling phone calls over 16 weeks.
During counseling calls, the study counselor will work with participants to develop smoking change goals, including smoking reduction, changing smoking contexts, and using NRT.
Counseling sessions will explore participants' motivations for changing their tobacco use and address pragmatic issues such as co-use with other substances, work contexts, smoking policies, and habits that interfere with desired changes.
Counseling will emphasize competence and self-efficacy, both of which will be linked to the practice of smoking change skills.
|
|
Comparador activo: Standard Care
Participants in Standard Care will be asked if they are interested in quitting smoking in the next month, and if so, they will be offered Cessation Treatment, which is consistent with existing VA standard care.
|
If a participant enters Cessation Treatment, they will receive combination NRT (patch with participant choice of mini-lozenge or gum).
Nicotine patch dosing, which will begin on the TQD, will be will be consistent with medication labeling; i.e., if smoking >10 cigarettes/day= starting at 21-mg; if smoking ≤10 cigarettes/day = starting at 14-mg nicotine patches.
Similarly, dosing for nicotine mini-lozenge/gum: <30 min to 1st cig/day starting at 4mg every 1-2 hours; if ≥30 min to 1st cig/day, then starting at 2mg every 1-2 hours.
Otros nombres:
All participants who enter cessation treatment will receive five, 15-20 minute counseling calls over 16 weeks.
Calls will be scheduled at approximately 1-week pre-target quit day (TQD), 1-day post TQD, and three flexible sessions up to week 16.
Prior to quitting, the study counselor will reinforce reasons for quitting, discuss past quit experiences, and develop a quit day plan.
Post-quit sessions will include coping with cravings, identifying high-risk situations (e.g., co-use with other substances), developing behavioral plans for high-risk situations, and a plan to manage a lapse/relapse.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Treatment Engagement
Periodo de tiempo: At the end of 4 month treatment
|
Rates of self-reported use of nicotine replacement therapy and attending at least one counseling session
|
At the end of 4 month treatment
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
24h Quit Attempt
Periodo de tiempo: At the end of 4 month treatment
|
Rates of self-reported quit attempt lasting at least 24 hours during the study
|
At the end of 4 month treatment
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Jennifer M. Betts, PhD, William S. Middleton Memorial Veterans Hospital, Madison, WI
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de abril de 2027
Finalización primaria (Estimado)
1 de abril de 2030
Finalización del estudio (Estimado)
30 de septiembre de 2031
Fechas de registro del estudio
Enviado por primera vez
3 de septiembre de 2026
Primero enviado que cumplió con los criterios de control de calidad
3 de septiembre de 2026
Publicado por primera vez (Actual)
9 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
14 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
9 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Desordenes mentales
- Trastornos inducidos químicamente
- Comportamiento
- De fumar
- Tabaquismo
- El consumo de tabaco
- Trastornos relacionados con sustancias
- Fumar cigarrillos
- Piridina
- Compuestos heterocíclicos, 1 anillo
- Compuestos heterocíclicos
- Terapéutica
- Alimento
- Dieta, alimentos y nutrición
- Fenómeno fisiológico
- Comida y bebidas
- Carbohidratos
- Alcaloides
- Polímeros
- Sustancias macromoleculares
- Polisacáridos
- Biopolímeros
- Encías vegetales
- Dulce
- Alcaloides solanáceos
- Goma de mascar
- Tabaco Use dispositivos para dejar de
- Nicotina
- Chicle de nicotina
Otros números de identificación del estudio
- NURA-001-25F
- 1IK2RD001577 (Otro número de subvención/financiamiento: Department of Veterans Affairs)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
Deidentified dataset will be shared upon request.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .