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- Ensayo clínico NCT00625131
Nicotine Patch Pretreatment for Smoking Cessation in PTSD
Nicotine Patch Pre-treatment for Smoking Cessation in PTSD
Descripción general del estudio
Estado
Descripción detallada
Smokers with PTSD will be randomly assigned to 1 of 2 pre-cessation patch therapy conditions (active patch versus placebo patch) for three weeks before a target quit-smoking date. All participants to will receive bupropion beginning 1 week prior to their quit day, given that they are medically eligible to be prescribed bupropion. All participants will receive a two session brief cognitive-behavioral therapy (CBT) session and will begin standard nicotine replacement therapy (NRT) on their quit day. PTSD symptoms, mood, and smoking craving will be carefully evaluated throughout the study using electronic diary assessments on personal digital assistants (PDA). Specifically, participants will carefully monitor their symptoms, mood, craving, and use of cigarettes using electronic diaries for one week prior to the pre-cessation period, during the 3-week pre-cessation treatment period, and 6 weeks post quit date. Since no previous study has examined factors associated with smoking abstinence following treatment among PTSD smokers10, predictors of treatment response will be examined. The study is designed to address the following items:
Specific Aim 1: To evaluate whether supplemental nicotine administration (i.e., pre-cessation treatment with nicotine patch and bupropion) will result in improved quit rates among smokers with PTSD.
Hypothesis 1.1 Supplemental nicotine administration during the pre-cessation period will result in improved quit rates in the first quit week over the placebo patch condition.
Specific Aim 2: To utilize electronic diary assessment of PTSD symptoms, mood, smoking craving, and smoking during baseline, pretreatment, and quit periods to evaluate potential mechanisms of how pretreatment with the nicotine patch may increase abstinence rates.
Hypothesis 2.1 Supplemental nicotine administration will decrease craving for cigarettes during the 2 week pretreatment period as compared to the placebo patch condition.
Hypothesis 2.2 Supplemental nicotine administration will decrease the perceived improvement in mood and PTSD symptoms associated with smoking behavior, i.e., symptom relief from ad lib smoking a cigarette will be reduced during supplemental nicotine administration as compared to the placebo patch condition.
Specific Aim 3: To investigate potential predictors of smoking abstinence and relapse associated with individual differences in affective style including anxiety sensitivity, measures of distress tolerance, and self-efficacy.
Hypothesis 3.1 Increased anxiety sensitivity will be predictive of shorter abstinence from smoking.
Hypothesis 3.2 Decreased distress tolerance will be predictive of shorter abstinence.
Hypothesis 3.3 Lower self-efficacy for smoking abstinence will be predictive of shorter abstinence.
Hypothesis 3.4 Increased PTSD symptoms severity and negative affect following the quit date will be associated with shorter abstinence.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase temprana 1
Contactos y Ubicaciones
Ubicaciones de estudio
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North Carolina
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Durham, North Carolina, Estados Unidos, 27705
- VA Medical Center, Durham
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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:
- Smokers who smoke 10 or more cigarettes per day in the past year;
- 18-80 years old;
- English speakers;
- medically stable;
- stable on current medication regimen
Exclusion Criteria:
- Pregnant women excluded;
- participants with organic mental disorder, schizophrenia, bipolar disorder, lifetime but not current PTSD, current substance abuse or dependence;
- medical conditions contraindicated with nicotine replacement therapy;
- use other forms of nicotine (cigars, nicotine gum, etc.)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: Active Nicotine Patch Group
Transdermal nicotine patch
|
Delivered through transdermal nicotine patch
Manualized protocol for CBT in smoking cessation
Otros nombres:
Antidepressant
Otros nombres:
|
Comparador de placebos: Placebo Patch Group
Transdermal placebo patch
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Manualized protocol for CBT in smoking cessation
Otros nombres:
Antidepressant
Otros nombres:
Pre-treatment placebo transdermal patch
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Smoking Abstinence, Self-reported
Periodo de tiempo: Week prior to Session 12 at 6 weeks post-treatment
|
Number of participants by group reporting 1 week of self-reported abstinence in the week prior to Session 12 at six weeks post-treatment
|
Week prior to Session 12 at 6 weeks post-treatment
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Carbon Monoxide Monitoring
Periodo de tiempo: Session 12 (6 weeks post-treatment)
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Number of participants whose carbon monoxide (CO) measurement indicated abstinence at Session 12 (6 weeks post-treatment)
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Session 12 (6 weeks post-treatment)
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Smoking Craving
Periodo de tiempo: Daily between visits 2-12
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Mean smoking craving score (as measured during daily ecological momentary, or diary, assessments) for participants by group during the two week period of placebo/active pre-treatment.
This is the main period of interest, as it was hypothesized that use of active nicotine patch would reduce smoking cravings during the pre-quit period.
The craving score is based on a single diary item "Please rate your desire to smoke right now" with a Likert scale score ranging from 1 (none) to 5 (severe).
Higher craving is "worse," as lower craving is presumed to reflect decreased risk of smoking lapse or relapse.
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Daily between visits 2-12
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jean C. Beckham, PhD, VA Medical Center, Durham
Publicaciones y enlaces útiles
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
Términos MeSH relevantes adicionales
- Desordenes mentales
- Trastornos inducidos químicamente
- Procesos Patológicos
- Trastornos relacionados con sustancias
- Trastornos relacionados con el trauma y el estrés
- Enfermedad
- Trastornos de Estrés, Traumáticos
- Trastornos de estrés postraumático
- Trastorno por consumo de tabaco
- Efectos fisiológicos de las drogas
- Agentes neurotransmisores
- Mecanismos moleculares de acción farmacológica
- Agentes Autonómicos
- Agentes del sistema nervioso periférico
- Agentes colinérgicos
- Inhibidores de enzimas
- Drogas psicotropicas
- Inhibidores de la captación de neurotransmisores
- Moduladores de transporte de membrana
- Agentes antidepresivos
- Agentes de dopamina
- Inhibidores de enzimas del citocromo P-450
- Estimulantes ganglionares
- Agonistas nicotínicos
- Agonistas colinérgicos
- Agentes antidepresivos, segunda generación
- Inhibidores del citocromo P-450 CYP2D6
- Inhibidores de la captación de dopamina
- Nicotina
- Bupropión
Otros números de identificación del estudio
- NEUA-007-07F
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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