- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00005922
Conditioning, the Placebo Effect, and Psoriasis
Role of Conditioning in the Pharmacotherapy of Psoriasis
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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California
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Palo Alto, California, 미국, 94305
- Stanford University
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New York
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Rochester, New York, 미국, 14642
- Adult Dermatology Clinic, Strong Memorial Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: A
Participants will receive 100% of the dose of the medication on the same reinforcement schedule (100%) as received during the baseline (maintenance) period.
|
Full dose of Aristicort A (0.1%) 2 times per day for a period of up to 14 weeks.
다른 이름들:
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실험적: 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.
다른 이름들:
|
실험적: 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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Routine and standard quantitative and qualitative assessment of plaque changes and growth
기간: Weekly
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Weekly
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Severity Index, clinically described as to redness, flaking and thickness on a total scale of 9
기간: Weekly
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Weekly
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2차 결과 측정
결과 측정 |
기간 |
---|---|
Impacts of Events Scale (IES)
기간: 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)
기간: Weekly
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Weekly
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Hassles Scale
기간: Weekly
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Weekly
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Interpersonal Support Evaluation List (ISEL)
기간: Once - at the intial start of the study
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Once - at the intial start of the study
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공동 작업자 및 조사자
수사관
- 수석 연구원: Robert Ader, PhD, University of Rochester
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- R01AR046825 (미국 NIH 보조금/계약)
- NIAMS-051
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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