- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02056626
Conditioned Pharmacotherapeutic Effects in Hypertension
Aperçu de l'étude
Description détaillée
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- when active drug is withdrawn and replaced by conditioned stimuli alone, resistance to extinction will be greater (i.e., rate of relapse will be less) among patients treated under a partial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.
Type d'étude
Inscription (Réel)
Phase
- Phase 4
Contacts et emplacements
Lieux d'étude
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New York
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Rochester, New York, États-Unis, 14642
- University of Rochester
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur actif: arm 2
partial reinforcement, 6.25 mg twice daily, 25% of time (15 days)
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Comparateur actif: arm 3
controlled dosing schedule 6.25 mg twice daily (15 days)
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Comparateur actif: arm 4
controlled dosing schedule 6.25 mg twice daily, every other day (15 days)
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Comparateur actif: arm 1
standard therapy, 25 mg twice daily (15 days)
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Mean Systolic Blood Pressure
Délai: day 0
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day 0
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Mean Systolic Blood Pressure
Délai: day 14
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day 14
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Mean Systolic Blood Pressure
Délai: day 30
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day 30
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: John D. Bisognano, M.D., Ph.D., University of Rochester
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies cardiovasculaires
- Maladies vasculaires
- Hypertension
- Effets physiologiques des médicaments
- Bêta-antagonistes adrénergiques
- Antagonistes adrénergiques
- Agents adrénergiques
- Agents neurotransmetteurs
- Mécanismes moléculaires de l'action pharmacologique
- Agents antihypertenseurs
- Agents vasodilatateurs
- Agents protecteurs
- Modulateurs de transport membranaire
- Hormones et agents régulateurs du calcium
- Bloqueurs de canaux calciques
- Antioxydants
- Antagonistes des récepteurs adrénergiques alpha-1
- Antagonistes alpha adrénergiques
- Carvédilol
Autres numéros d'identification d'étude
- 5R01HL105520 (Subvention/contrat des NIH des États-Unis)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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