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- Ensayo clínico NCT01772641
A Smoking Intervention Study Using Scheduled Gradual Reduction With Varenicline to Help With Cessation
14 de marzo de 2016 actualizado por: Joel Erblich, Icahn School of Medicine at Mount Sinai
A Combination of Scheduled Reduced Smoking With Varenicline to Enhance Cessation
This study has three main aims.
Aim 1: To provide initial data on the efficacy of combined Scheduled Gradual Reduction (SGR) and Varenicline (VN) for smoking cessation, by assessing abstinence and levels of smoking at 2 time points (4 and 12 weeks post quit).
Aim 2: To explore the possibility that SGR+VN will be particularly efficacious among smokers with higher background levels of Cue Reactivity (CR), as assessed at the start of the study, using a classic experimental smoking CR paradigm.
Aim 3: To explore possible mechanisms underlying the effects of SGR+VN, by assessing potential mediators (i.e., self-efficacy, cue-induced cravings) of treatment effects.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
Smoking remains an intransigent public health concern.
There is ample evidence that non-pharmacological factors, such as environmental triggers (e.g., sight or smell of a cigarette), can give rise to strong classically-conditioned urges to smoke (termed 'cue-reactivity' [CR]), and that exposure to smoking cues can contribute to cessation failure.
One promising intervention that may address CR is scheduled smoking with gradual reduction (SGR).
Under SGR, individuals smoke only at fixed intervals, and over several weeks, systematically decrease their cigarettes consumed each day.
The approach is postulated to: 1) provide 'practice' coping with environmentally-triggered cravings that occur during the inter-cigarette intervals, yielding increased self-efficacy to quit, and 2) weaken the associations between cues and smoking.
Accumulating evidence has also shown that the smoking cessation drug, varenicline (VN), substantially ameliorates cravings and enhances cessation, significantly outperforming other drugs.
Interestingly, recent animal research suggests that VN may operate at least partially by dampening conditioned drug cravings.
A combination therapy consisting of SGR+VN might thus lead to significantly enhanced cessation, simultaneously attacking cravings using both pharmacological and non-pharmacological approaches.
Because the beneficial effects of SGR and VN may be at least partially due to enhanced management of conditioned cravings, it is possible that that they will be particularly efficacious for smokers with high levels of CR.
Using both laboratory experimental techniques and a prospective intervention design in this R34 application, we propose to provide initial data to: 1) test the hypothesis that a combination of SGR+VN will enhance cessation, 2) explore the possibility that SGR and VN might be particularly efficacious among smokers with higher levels of CR, and 3) explore potential mechanisms underlying treatment effects.
Findings from this study would set the stage for larger efficacy and effectiveness trials of SGR alone and in conjunction with VN, as well as efforts to target SGR and/or VN toward the subgroups that would benefit the most (e.g., smokers with high levels of CR, carriers of specific smoking-related genotypes).
Tipo de estudio
Intervencionista
Inscripción (Actual)
32
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.
Ubicaciones de estudio
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New York
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New York, New York, Estados Unidos, 10029
- Icahn School of Medicine at Mount Sinai
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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
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Current cigarette smoker
- Averages at least 10 cigarettes/day for 5 or more years
- DSM-IV diagnosis of Nicotine Dependence
- Breath carbon monoxide > 6 ppm
- Motivated to quit: score > 8 on Contemplation Ladder
- Age > 18 years
Exclusion Criteria:
- Current illicit substance use
- Other tobacco use (e.g., cigar, pipe)
- History of psychosis
- Past or current cardiovascular disease
- Impaired renal functioning
- Pregnancy
- Nursing
- Current treatment for smoking cessation
- Clinically significant depressive symptoms (CES-D > 16)
- Current suicidal ideation
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 factorial
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Scheduled Gradual Reduction + Varenicline
Participants will be given the behavioral intervention of Scheduled Gradual Reduction along with the smoking cessation drug, Varenicline.
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Participants will receive a four-week Scheduled Gradual Reduction (SGR) intervention in which participants cut down on the number of cigarettes smoked.
This is done through a smoking schedule in which participants smoke a cigarette at given fixed and equal intervals throughout their waking day.
Additionally, they will take 0.5 mg of Varenicline (VN) once a day for the first three days, then 0.5 mg twice a day for the next four days, and they will continue for 13 weeks at 1.0 mg twice per day.
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Experimental: Scheduled Gradual Reduction + Placebo Drug
Participants will be given the behavioral intervention, SGR, along with a placebo drug matching the schedule of the VN group.
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Participants will receive a four-week Scheduled Gradual Reduction (SGR) intervention in which participants cut down on the number of cigarettes smoked.
This is done through a smoking schedule in which participants smoke a cigarette at given fixed and equal intervals throughout their waking day.
Additionally, they will take placebo pills matching the schedule of the VN group.
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Experimental: Basic Advice + Varenicline
Participants will be given basic advice about quitting smoking along with the smoking cessation drug Varenicline
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Participants will receive informational pamphlets with advice about quitting smoking.
Additionally, they will take 0.5 mg of Varenicline (VN) once a day for the first three days, then 0.5 mg twice a day for the next four days, and they will continue for 13 weeks at 1.0 mg twice per day.
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Comparador de placebos: Basic Advice + Placebo Drug
Participants will be given basic advice along with a placebo drug matching the schedule of the VN group.
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Participants will receive informational pamphlets with advice about quitting smoking.
Additionally, they will take placebo pills matching the schedule of the VN group.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Comparison of Prolonged Abstinence
Periodo de tiempo: up to12 weeks post-quit
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Prolonged Abstinence from 12 weeks post-quit as compared to 4 weeks post-quit
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up to12 weeks post-quit
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Comparison of Continuous Abstinence
Periodo de tiempo: 30 days post-quit and 30 days post end-of-treatment
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Continuous Abstinence as compared from 30 days post-quit to 30 days post end-of-treatment
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30 days post-quit and 30 days post end-of-treatment
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Comparison of Survival
Periodo de tiempo: 30 days post-quit and 30 days post end-of-treatment
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Survival as compared from 30 days post-quit to 30 days post end-of-treatment
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30 days post-quit and 30 days post end-of-treatment
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Joel Erblich, Ph.D, Icahn School of Medicine at Mount Sinai
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
1 de diciembre de 2012
Finalización primaria (Actual)
1 de enero de 2014
Finalización del estudio (Actual)
1 de enero de 2014
Fechas de registro del estudio
Enviado por primera vez
17 de enero de 2013
Primero enviado que cumplió con los criterios de control de calidad
18 de enero de 2013
Publicado por primera vez (Estimar)
21 de enero de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
16 de marzo de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
14 de marzo de 2016
Última verificación
1 de marzo de 2016
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Desordenes mentales
- Trastornos inducidos químicamente
- Trastornos relacionados con sustancias
- Trastorno por consumo de tabaco
- Efectos fisiológicos de las drogas
- Agentes neurotransmisores
- Mecanismos moleculares de acción farmacológica
- Agentes colinérgicos
- Agonistas nicotínicos
- Agonistas colinérgicos
- Vareniclina
Otros números de identificación del estudio
- GCO 10-0879
- 5R34DA031327-02 (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. .