Manipulating learning mechanisms to alter nocebo effects: A pharmacological neuroimaging study on pain and itch.

Phase 1

• Conditions: ocebo effects on pain and itch; Therapeutic area: Body processes [G] - Physical Phenomena [G01]

• Registration Number: EUCTR2018-002637-37-NL
• Lead Sponsor: eiden University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-12-20
• Last Update Posted: 16 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

To be eligible, participants must meet all of the following criteria:
1.Between 18 and 35 years of age
2.Good understanding of spoken and written English
3.Native Dutch speaker
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A potential subject who meets any of the following exclusion criteria will be excluded from participation in this study:
1.History of serious or chronic medical or psychiatric conditions
2.History of chronic pain or itch conditions
3.Experiencing pain or itch on the day of testing
4.Currently using antihistamines, analgesic medication, or itch-reducing medication (in the 12 hours prior to testing)
5.Recent use of psychotropic drugs (including recreational drugs such as cannabis and psychotropic prescription-medication; in the past month)
6.Currently being (or intending to become) pregnant, or currently breastfeeding
7.Colour-blindness
8.Body Mass Index under 16 or over 30
9.Meeting any exclusion criteria for entering the MR scanner (e.g., permanent metal parts in the body)
10.Having a too high threshold for pain (where high pain cannot be induced with temperatures lower than 49.5 °C) or not responding to histamine (no itch response)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified