- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02056626
Conditioned Pharmacotherapeutic Effects in Hypertension
Descripción general del estudio
Descripción detallada
The proposed research is designed to determine if the application of classical conditioning operations could influence the clinical effects of a regimen of antihypertensive drug therapy. In a double-blind, randomized, parallel-controlled clinical trial, It will be determined if, capitalizing on conditioned pharmacotherapeutic effects, patients can be effectively treated with smaller cumulative amounts of drug. To this end, some hypertensive patients will be treated on a partial rather than a continuous schedule of pharmacologic reinforcement. These patients will be compared to: (a) patients who continue to be treated under a standard regimen of pharmacotherapy at an effective dose of drug, and (b) patients who receive the same (reduced) cumulative amount of medication on a continuous schedule of reinforcement as that received by experimental patients treated under a partial schedule of reinforcement, and (c) patients who receive the same dose and frequency of carvedilol as the Partial Reinforcement Group but receive no intervening conditioned stimuli.
It is possible that a non-continuous schedule of pharmacologic reinforcement (and the concomitant reduced amount of active drug) will exert effects that are indistinguishable from a continuous (standard) regimen of pharmacotherapy (a higher cumulative amount of drug). That outcome or comparison, however, is not critical for evaluating the role of conditioning in the pharmacotherapy of hypertension. Specifically, we will test the hypotheses that:
patients treated under a partial schedule of antihypertensive medication will show a greater amelioration of symptoms than that achieved by patients treated with that same (reduced) amount of drug administered under a continuous schedule of reinforcement;
Conditions permitting, we will also test the predictions that:
- irrespective of initial treatment regimen, relapse will occur more quickly following withdrawal of active medication in patients who do not continue to receive conditioned stimuli (placebo) than in patients who continue to receive conditioned stimuli; and
- when active drug is withdrawn and replaced by conditioned stimuli alone, resistance to extinction will be greater (i.e., rate of relapse will be less) among patients treated under a partial schedule of reinforcement than patients treated with the same amount of drug administered under a continuous schedule of reinforcement (the partial reinforcement effect).
Positive results would transform the study and practice of pharmacotherapy with respect to placebo effects by providing a new model within which to design treatment protocols for patients with chronic diseases that capitalizes on conditioned pharmacotherapeutic responses. The model, from which testable hypotheses can be derived, also provides a new framework for research on placebo effects and the mechanisms underlying such phenomena.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
New York
-
Rochester, New York, Estados Unidos, 14642
- University of Rochester
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- systolic blood pressure between 140-160 mmHG
- between 18-80 years old
Exclusion Criteria:
- abnormal renal function
- currently pregnant, or trying to become pregnant
- being treated with a beta-blocker
- use of illicit drugs
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: arm 2
partial reinforcement, 6.25 mg twice daily, 25% of time (15 days)
|
|
Comparador activo: arm 3
controlled dosing schedule 6.25 mg twice daily (15 days)
|
|
Comparador activo: arm 4
controlled dosing schedule 6.25 mg twice daily, every other day (15 days)
|
|
Comparador activo: arm 1
standard therapy, 25 mg twice daily (15 days)
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Mean Systolic Blood Pressure
Periodo de tiempo: day 0
|
day 0
|
Mean Systolic Blood Pressure
Periodo de tiempo: day 14
|
day 14
|
Mean Systolic Blood Pressure
Periodo de tiempo: day 30
|
day 30
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: John D. Bisognano, M.D., Ph.D., University of Rochester
Publicaciones y enlaces útiles
Publicaciones Generales
- WOLF S. Effects of suggestion and conditioning on the action of chemical agents in human subjects; the pharmacology of placebos. J Clin Invest. 1950 Jan;29(1):100-9. doi: 10.1172/JCI102225. No abstract available.
- LASAGNA L, MOSTELLER F, VON FELSINGER JM, BEECHER HK. A study of the placebo response. Am J Med. 1954 Jun;16(6):770-9. doi: 10.1016/0002-9343(54)90441-6. No abstract available.
- KNOWLES JB. CONDITIONING AND THE PLACEBO EFFECT: THE EFFECTS OF DECAFFEINATED COFFEE ON SIMPLE REACTION TIME IN HABITUAL COFFEE DRINKERS. Behav Res Ther. 1963 Aug;1:151-7. doi: 10.1016/0005-7967(63)90018-4. No abstract available.
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 (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
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Hipertensión
- Efectos fisiológicos de las drogas
- Beta-antagonistas adrenérgicos
- Antagonistas adrenérgicos
- Agentes adrenérgicos
- Agentes neurotransmisores
- Mecanismos moleculares de acción farmacológica
- Agentes antihipertensivos
- Agentes vasodilatadores
- Agentes Protectores
- Moduladores de transporte de membrana
- Hormonas y agentes reguladores del calcio
- Bloqueadores de los canales de calcio
- Antioxidantes
- Antagonistas de los receptores adrenérgicos alfa-1
- Antagonistas alfa adrenérgicos
- Carvedilol
Otros números de identificación del estudio
- 5R01HL105520 (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. .
Ensayos clínicos sobre carvedilol
-
Chong Kun Dang PharmaceuticalTerminadoHipertensiónCorea, república de
-
Zunyi Medical CollegeDesconocidoApendicitis CrónicaPorcelana
-
GlaxoSmithKlineTerminado
-
Southeast University, ChinaReclutamientoInfección por enterobacterias resistentes a carbapenémicosPorcelana
-
E-DA HospitalTerminadoSangrado VaricealTaiwán
-
Institute of Liver and Biliary Sciences, IndiaReclutamiento
-
Owen Chan, PhDTerminadoDesconocimiento de la hipoglucemiaEstados Unidos
-
University of MinnesotaGlaxoSmithKlineTerminadoPre-hipertensiónEstados Unidos
-
GlaxoSmithKlineTerminadoInsuficiencia Cardíaca CongestivaJapón
-
Andhra Medical CollegeTerminadoFibrilación auricular