PsoriasisNCT00005922
Conditioning, the Placebo Effect, and Psoriasis
A study testing Partial schedule of pharmacotherapeutic reinforcement and Standard pharmacotherapeutic protocol in people with Psoriasis, run by University of Rochester at 2 sites in United States.
Trial summary
This study uses the psychological principle known as classical conditioning to try to improve the standard treatment of psoriasis. Classical conditioning is a process of behavioral modification in which a person learns to connect a certain response-in this case, improvement of psoriasis-with a new action, or… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- Partial schedule of pharmacotherapeutic reinforcement and Standard pharmacotherapeutic protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2000to Jul 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Stanford University
Palo Alto, California, 94305
Adult Dermatology Clinic, Strong Memorial Hospital
Rochester, New York, 14642
About this study
Official title: Role of Conditioning in the Pharmacotherapy of Psoriasis
This study uses the psychological principle known as classical conditioning to try to improve the standard treatment of psoriasis. Classical conditioning is a process of behavioral modification in which a person learns to connect a certain response-in this case, improvement of psoriasis-with a new action, or stimulus-in this case, application of an inactive cream. The goal of this study is to show that people with psoriasis who are maintained on corticosteroid cream part of the time and an inactive (placebo) cream at other times show a lower incidence of relapse and a reduced severity of psoriasis that patients treated with that same (reduced) amount of medication administered all the time.
Read the detailed description
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.
- Conditions
- Psoriasis
- Being tested
- Partial schedule of pharmacotherapeutic reinforcement, Dose control for Arm B, Standard pharmacotherapeutic protocol
- Keywords
- Conditioning, Corticosteroid, Lesions, Pharmacotherapy, Placebo effect, Psoriasis, Psychoneuroimmunology
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial schedule of pharmacotherapeutic reinforcementBehavioural
Also called Aristocort A
Dose of 0.1% of Aristocort A on 1-2 of every 4 days for a period of up to 14 weeks.
Dose control for Arm BDrug
Also called Aristocort A
Dose of 0.025-0.05% of Aristocort A 2 times per day for a period of up to 14 weeks.
Standard pharmacotherapeutic protocolOther
Also called Aristicort A
Full dose of Aristicort A (0.1%) 2 times per day for a period of up to 14 weeks.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Participants will receive 100% of the dose of the medication on the same reinforcement schedule (100%) as received during the baseline (maintenance) period. Receives: Other: Standard pharmacotherapeutic protocol |
| B | Experimental | 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 Receives: Behavioral: Partial schedule of pharmacotherapeutic reinforcement |
| C | Experimental | 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. Receives: Drug: Dose control for Arm B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Routine and standard quantitative and qualitative assessment of plaque changes and growth
Measured: Weekly
Severity Index, clinically described as to redness, flaking and thickness on a total scale of 9
Measured: Weekly
Secondary outcomes (4)
Impacts of Events Scale (IES)
Measured: Once - at the initial start of the study
Psoriasis Life Stress Inventory) (PLSI)
Measured: Weekly
Hassles Scale
Measured: Weekly
Interpersonal Support Evaluation List (ISEL)
Measured: Once - at the intial start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2000 (estimated)
- Study startAug 2000
- Primary completionJul 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Investigators
- Robert Ader, PhD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005922
- Sponsor's protocol ID
- R01AR046825
- Other IDs
- R01AR046825, NIAMS-051
- Status last verified
- Sep 2013
- First submitted
- 22 Jun 2000
- Last updated
- 24 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ader R, Cohen N. Behaviorally conditioned immunosuppression. Psychosom Med. 1975 Jul-Aug;37(4):333-40. doi: 10.1097/00006842-197507000-00007.
PubMed 1162023Ader 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.
PubMed 7815892Giang 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.
PubMed 9081556Ader 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Conditioning in the Pharmacotherapy of Psoriasis
- ClinicalTrials.gov ID
- NCT00005922
- Acronym / sponsor ID
- R01AR046825
- Conditions
- Psoriasis
- Keywords
- Conditioning, Corticosteroid, Lesions, Pharmacotherapy, Placebo effect, Psoriasis, Psychoneuroimmunology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Aug 2000
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 23 Jun 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study uses the psychological principle known as classical conditioning to try to improve the standard treatment of psoriasis. Classical conditioning is a process of behavioral modification in which a person learns to connect a certain response-in this case, improvement of psoriasis-with a new action, or stimulus-in this case, application of an inactive cream. The goal of this study is to show that people with psoriasis who are maintained on corticosteroid cream part of the time and an inactive (placebo) cream at other times show a lower incidence of relapse and a reduced severity of psoriasis that patients treated with that same (reduced) amount of medication administered all the time.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Other: Standard pharmacotherapeutic protocolParticipants will receive 100% of the dose of the medication on the same reinforcement schedule (100%) as received during the baseline (maintenance) period. |
| B | Experimental | Behavioral: Partial schedule of pharmacotherapeutic reinforcementParticipants will receive 100% of the dose of the medication on a partial reinforcement schedule (25% or 50%) as received during the baseline (maintenance) period |
| C | Experimental | Drug: Dose control for Arm BParticipants will receive 25% or 50% of the dose of the medication on the same reinforcement schedule (100%) as received during the baseline (maintenance) period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Partial schedule of pharmacotherapeutic reinforcementAlso: Aristocort ADose of 0.1% of Aristocort A on 1-2 of every 4 days for a period of up to 14 weeks. | Behavioural | B |
| Dose control for Arm BAlso: Aristocort ADose of 0.025-0.05% of Aristocort A 2 times per day for a period of up to 14 weeks. | Drug | C |
| Standard pharmacotherapeutic protocolAlso: Aristicort AFull dose of Aristicort A (0.1%) 2 times per day for a period of up to 14 weeks. | Other | A |
Primary outcome
Routine and standard quantitative and qualitative assessment of plaque changes and growth
Time frame: Weekly
Severity Index, clinically described as to redness, flaking and thickness on a total scale of 9
Time frame: Weekly
4 secondary outcomes
Impacts of Events Scale (IES)
Time frame: Once - at the initial start of the study
Psoriasis Life Stress Inventory) (PLSI)
Time frame: Weekly
Hassles Scale
Time frame: Weekly
Interpersonal Support Evaluation List (ISEL)
Time frame: Once - at the intial start of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2013.
- Background: PubMed 1162023Ader R, Cohen N. Behaviorally conditioned immunosuppression. Psychosom Med. 1975 Jul-Aug;37(4):333-40. doi: 10.1097/00006842-197507000-00007.
- Background: PubMed 7815892Ader 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.
- Background: PubMed 9081556Giang 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.
- BackgroundAder 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Ader, PhD principal investigator
University of Rochester
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partial schedule of pharmacotherapeutic reinforcement and Standard pharmacotherapeutic protocol in people with Psoriasis, run by University of Rochester at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Routine and standard quantitative and qualitative assessment of plaque changes and growth (time frame: Weekly). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005922, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2013.