- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00005922
Conditioning, the Placebo Effect, and Psoriasis
Role of Conditioning in the Pharmacotherapy of Psoriasis
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
The lack of scientific attention devoted to the placebo effect as a phenomenon in its own right probably reflects the paucity of theoretical positions within which to organize the existing data and design new research. This research addresses the clinical significance of behavior-immune system interactions.
This study will capitalize on conditioned immunosuppressive responses to reduce the cumulative amount of corticosteroid medication used in the treatment of psoriasis. We will continue to treat patients with steroid, but will shift experimental patients from their current schedule of continuous reinforcement (active drug whenever medication is applied) to a partial schedule of reinforcement (active drug a percentage of the time and placebo alone at other times). To equate amount of medication, we will treat another group of patients with a reduced dose of steroid in a standard treatment regimen (continuous schedule of reinforcement).
We hypothesize that, holding cumulative dose constant, a partial schedule of reinforcement will enable patients to be maintained on lower cumulative amounts of corticosteroid than patients treated under a continuous schedule of active drug. This is the first attempt to adopt conditioning principles and use schedules of reinforcement to design regimens of drug therapy. If proven effective, this new approach to pharmacotherapy and placebo effects is likely to stimulate new interdisciplinary research in neuropharmacology and behavioral pharmacology for the treatment of autoimmune disorders and a variety of other chronic diseases.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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California
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Palo Alto, California, Stati Uniti, 94305
- Stanford University
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New York
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Rochester, New York, Stati Uniti, 14642
- Adult Dermatology Clinic, Strong Memorial Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Psoriasis patients with mild to moderate lesions who are able to attend weekly clinic visits at either the University of Rochester School of Medicine and Dentistry in Rochester, NY, or Stanford University in Palo Alto, CA.
- Patients must be in good health (as determined by prescreening examination).
- Patients must not be using systemic treatment (for example, oral medications) or intralesional, UV, or topical therapies except bland emollients for at least 2 weeks before the start date of the study.
- Patients must have chronic, stable plaque psoriasis with a score of greater than or equal to 7 on a routine 9-point Severity Index.
Exclusion Criteria:
- Use of immunosuppressive medication within the past 2 months.
- Pregnant or sexually active women who do not use contraceptives.
- Patients who cannot be monitored regularly.
- History of allergy to corticosteroid or other study ointment components.
- Patients who have more than 10 percent of body surface area covered by psoriatic lesions.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: A
Participants will receive 100% of the dose of the medication on the same reinforcement schedule (100%) as received during the baseline (maintenance) period.
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Full dose of Aristicort A (0.1%) 2 times per day for a period of up to 14 weeks.
Altri nomi:
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Sperimentale: B
Participants will receive 100% of the dose of the medication on a partial reinforcement schedule (25% or 50%) as received during the baseline (maintenance) period
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Dose of 0.1% of Aristocort A on 1-2 of every 4 days for a period of up to 14 weeks.
Altri nomi:
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Sperimentale: C
Participants will receive 25% or 50% of the dose of the medication on the same reinforcement schedule (100%) as received during the baseline (maintenance) period.
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Dose of 0.025-0.05% of Aristocort A 2 times per day for a period of up to 14 weeks.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Routine and standard quantitative and qualitative assessment of plaque changes and growth
Lasso di tempo: Weekly
|
Weekly
|
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Severity Index, clinically described as to redness, flaking and thickness on a total scale of 9
Lasso di tempo: Weekly
|
Weekly
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Impacts of Events Scale (IES)
Lasso di tempo: Once - at the initial start of the study
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Once - at the initial start of the study
|
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Psoriasis Life Stress Inventory) (PLSI)
Lasso di tempo: Weekly
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Weekly
|
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Hassles Scale
Lasso di tempo: Weekly
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Weekly
|
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Interpersonal Support Evaluation List (ISEL)
Lasso di tempo: Once - at the intial start of the study
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Once - at the intial start of the study
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Robert Ader, PhD, University of Rochester
Pubblicazioni e link utili
Pubblicazioni generali
- Ader R, Cohen N. Behaviorally conditioned immunosuppression. Psychosom Med. 1975 Jul-Aug;37(4):333-40. doi: 10.1097/00006842-197507000-00007.
- Ader R, Cohen N, Felten D. Psychoneuroimmunology: interactions between the nervous system and the immune system. Lancet. 1995 Jan 14;345(8942):99-103. doi: 10.1016/s0140-6736(95)90066-7. No abstract available.
- Giang DW, Goodman AD, Schiffer RB, Mattson DH, Petrie M, Cohen N, Ader R. Conditioning of cyclophosphamide-induced leukopenia in humans. J Neuropsychiatry Clin Neurosci. 1996 Spring;8(2):194-201. doi: 10.1176/jnp.8.2.194.
- Ader R. "The role of conditioning in pharmacotherapy." In The placebo effect: An interdisciplinary exploration, edited by A. Harrington, 138-165. Cambridge: Harvard University Press, 1997.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie della pelle
- Malattie della pelle, papulosquamose
- Psoriasi
- Effetti fisiologici delle droghe
- Meccanismi molecolari dell'azione farmacologica
- Inibitori enzimatici
- Agenti antinfiammatori
- Agenti immunosoppressivi
- Fattori immunologici
- Glucocorticoidi
- Ormoni
- Ormoni, sostituti ormonali e antagonisti ormonali
- Triamcinolone
- Triamcinolone acetonide
- Triamcinolone esacetonide
- Triamcinolone diacetato
Altri numeri di identificazione dello studio
- R01AR046825 (Sovvenzione/contratto NIH degli Stati Uniti)
- NIAMS-051
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .