- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00714896
Interventions for Smoking Among Persons in Recovery (INSPIRE)
A Stepped-Care Intervention for Current and Former Smokers in Outpatient Chemical Dependency Treatment
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The objective of the study is to document and systematically investigate the use of smoking cessation strategies targeting substance abuse outpatient smokers at various level of readiness to quit smoking. Little is known regarding the best practices in treating tobacco use among clients in drug abuse treatment and very few drug abuse treatment programs currently offer smoking cessation services. The purpose of this developmental study is to develop and pre-test a stepped-care smoking cessation intervention in an outpatient drug abuse treatment program at a managed care setting that targets both current and former smokers. The stepped-care intervention consists of various components that aim at matching the treatment needs of smokers across the whole spectrum of smoking status and readiness to quit smoking. The following specific aims will be pursued:
- Develop a stepped-care smoking cessation intervention targeting both current and former smokers who are admitted to an outpatient drug abuse treatment program. Special attention will be paid to former smokers, as intervention techniques for them are not well developed. Also, intervention content will be modified from that used in smoking interventions with the general population to content that is targeted at smokers who are in drug abuse treatment
- Pre-test the efficacy of the stepped-care smoking cessation intervention.
- Examine the feasibility of implementing the stepped-care smoking cessation intervention.
- Examine the impact of the smoking intervention on drug and alcohol use outcomes at 6-month post initiation of smoking cessation treatment.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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-
California
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Walnut Creek, California, Estados Unidos, 94596
- Kaiser Permanente Central Diablo (Wlanut Creek/ Martinez)
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- men and women
- over the age of 18
- currently enrolled in outpatient treatment program for drug and/or alcohol use and have received minimally 30 days of continuous treatment for drug and/alcohol in any outpatient treatment program(s) for drug and/or alcohol use for at least one month
- have regularly smoked cigarettes for at least one year in their lifetime
- have smoked within the past 5 years
Exclusion Criteria:
- clients with a life-threatening disease
- currently at imminent risk of committing suicide, or currently pregnant
- currently in treatment for nicotine dependence elsewhere
- cannot be reached by telephone (unable to provide a phone number where the participant can be reached directly
- non-English speakers.
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 |
---|---|
Otro: 1
Assessment only + referral list to State quitline and smoking cessation education classes at Kaiser
|
Referral list to smoking cessation classes at Kaiser and the California Smokers Helpline
|
Experimental: 2
Participants will receive self-help information handouts, expert system intervention that includes a stage-based manual and individualized written feedback reports plus in-person brief stage-appropriate counseling at baseline and 3-month assessment.
Current smokers who indicate desire to quit smoking or former smokers who indicate high cravings for cigarettes will be offered nicotine replacement medications.
Participants will receive three telephone counseling sessions delivered between baseline and 3 month at weeks 2, 4 and 8. As-needed telephone check-calls will be provided to participants on and 2 days after quit date, or to participants who have quit smoking and anticipate high risk situations.
|
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
CO verified self-report 7-day smoking abstinence prior to assessment
Periodo de tiempo: 6 months
|
6 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Janice Tsoh, PhD, University of California, San Francisco
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- P50DA009253-14-DevStudy2
- H10315-28247-03
- P50DA009253-14 (Subvención/contrato del NIH de EE. UU.)
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. .
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