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Trial record 30 of 58417 for:    Placebo

Back to Basics - Effects, Narratives and Routes of Administration of Open-label Placebo

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ClinicalTrials.gov Identifier: NCT02578420
Recruitment Status : Completed
First Posted : October 19, 2015
Last Update Posted : July 26, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief Summary:
To date, very little is known about the mechanisms of open-label placebo treatment and there is a lack in highly controlled experimental designs. Therefore, the planned project will test well-established explanatory models of (deceptive) placebo, i.e., (1) expectancy, (2) meaning response, in an open-label placebo design, investigating their influence on placebo analgesia.

Condition or disease Intervention/treatment Phase
Placebo Effect Pain Expectancy Other: open-label placebo Other: deceptive placebo Not Applicable

Detailed Description:

The current project will consist of one experimental study and one qualitative study:

  1. the effects of open-label, and deceptive placebo administration on placebo analgesia will be directly compared when both groups have a comparable expectancy-inducing scientific rationale;
  2. subjective meaning models will be assessed by comparing subjective narratives of the placebo effect in open-label and deceptive placebo groups in a nested qualitative study.

The experimental study will be a randomized experiment with healthy subjects (N=120), and pain will be induced using a standardized heat pain paradigm (Medoc, Ramatishai, Israel; thermo-sensory analyzer (TSA)-II). Effects of the experimental conditions will be assessed both objectively (i.e. heat pain threshold and tolerance) and subjectively (i.e. subjective pain ratings, pain intensity and unpleasantness). Furthermore, investigators will randomly select 30 participants to take part in a nested qualitative study in order to qualitatively assess the meaning response by comparing subjective narratives of the placebo effect in the open-label and deceptive placebo groups, as well as in the control group.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Back to Basics - Effects, Narratives and Routes of Administration of Open-label Placebo
Study Start Date : January 2016
Actual Primary Completion Date : July 2016
Actual Study Completion Date : June 2017

Arm Intervention/treatment
Placebo Comparator: open-label placebo
Participants (N=40) will have the information that they are receiving an inert cream (i.e. "placebo"). Placebo will be described as an inert or inactive cream, with no medication in it. Additionally, participants will be told that "placebo has been shown in rigorous clinical testing to produce significant mind-body self-healing processes." The placebo administration will be combined with the following scientific rationale/verbal suggestion: (a) placebos are effective analgesics, (b) classical conditioning as a possible mechanism of this effect, (c) compliance is important for outcome and (d) positive expectations increase placebo effects, but are not necessary.
Other: open-label placebo
Placebo Cream, openly described as "Placebo"

Sham Comparator: deceptive placebo
Participants (N=40) will have the information that they are receiving an analgesic cream ("Antidolor, containing "Lidocain"), while in fact they will receive an inert cream, only. Antidolor will be described as an analgesic cream.
Other: deceptive placebo
Placebo Cream, described as "Voltaren, containing Diclofenac"

Placebo Comparator: control group
Participants (N=40) will have the information that they are receiving an inert control cream.
Other: open-label placebo
Placebo Cream, openly described as "Placebo"

No Intervention: no treatment group
Participants (N=40) will be told that they are in the "no treatment group" and that they will not receive an analgesic cream.



Primary Outcome Measures :
  1. subjective intensity and unpleasantness ratings of heat pain tolerance [ Time Frame: 2 hours ]
    Visual Analogue Scale (VAS)

  2. objective heat pain tolerance [ Time Frame: 2 hours ]
    Temperatures


Secondary Outcome Measures :
  1. Expectancy of Relief Scale (ERS; Erwartungsfragebogen) [ Time Frame: 2 hours ]
  2. Credibility and Effectiveness of the placebo analgesia expectation; adapted Version of the Context Model Questionnaire; Kontextmodellfragebogen (KMF) [ Time Frame: 2 hours ]
  3. multidimensional sensitivities questionnaire (Mehrdimensionaler Befindlichkeitsfragebogen (MDBF)) [ Time Frame: 2 hours ]
  4. sociodemographic questionnaire (Soziodemographischer Fragebogen (SDD)) [ Time Frame: 2 hours ]
  5. Revised Life Orientation Test (LOT-R) [ Time Frame: 2 hours ]
  6. NEO five-factor inventory (NEO-FFI) [ Time Frame: 2 hours ]
  7. questionnaire on competence and locus of control (Fragebogen zu Kompetenz- und Kontrollüberzeugungen (FKK)) [ Time Frame: 2 hours ]
  8. Anxiety and Depression Scale (HADS-D) [ Time Frame: 2 hours ]
  9. Beliefs in holistic health and holistic treatments; Complementary and Alternative Medicine Beliefs Intentory (CAMBI) [ Time Frame: 2 hours ]
  10. Desire for Relief Scale (DRS) [ Time Frame: 2 hours ]
  11. subjective intensity and unpleasantness ratings of heat pain threshold [ Time Frame: 2 hours ]
    Visual Analogue Scale (VAS)

  12. objective heat pain threshold [ Time Frame: 2 hours ]
    Temperatures



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and female adults aged 18-65
  • Healthy by self-report statement, thus no known current or chronic somatic diseases or psychiatric disorders
  • Right-handedness (Oldfield, 1971),
  • Willing to participate in study

Exclusion Criteria:

  • Medicine or Psychology Students
  • Any acute or chronic disease (chronic pain, hypertension, heart disease, renal disease, liver disease, diabetes) as well as skin pathologies, neuropathies or nerve entrapment symptoms, sensory abnormalities affecting the tactile or thermal modality
  • Current medications (psychoactive medication, narcotics, intake of analgesics) or being currently in psychological or psychiatric treatment
  • Insufficient German language skills to understand the instructions
  • Previous participation in studies using pain assessment (threshold and tolerance) with Peltier Devices
  • Daily consumption of more than three alcoholic standard beverages per day (a standard alcoholic beverage is defined as either 3dl beer or 1 dl wine or 2cl spirits)
  • Current or regular drug consumption (THC, cocaine, heroin, etc.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02578420


Locations
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Switzerland
University of Basel
Basel, Switzerland, 4055
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Study Chair: Jens Gaab, Prof Clinical Psychology and Psychotherapy, Department of Psychology, University of Basel

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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02578420     History of Changes
Other Study ID Numbers: EKNZ 2015-246
First Posted: October 19, 2015    Key Record Dates
Last Update Posted: July 26, 2017
Last Verified: July 2017