Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06350786
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-02
First Post:
2024-03-14
Brief Title:
Conditioned Open-label Placebos to Facilitate Opioid Reduction in Patients With Chronic Non-cancer Pain
Sponsor:
Cosima Locher
Organization:
University of Zurich
Study Overview
Official Title:
Conditioned Open-label Placebos to Facilitate the Reduction of Opioid Medication ROM in Patients With Chronic Non-cancer Pain a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ROM
Brief Summary:
This study aims to evaluate whether the reduction of the daily morphine equivalent dose MED in patients with chronic non-cancer pain CNCP can be decreased with an open-label placebo OLP intervention in comparison to an electronic monitoring EM control group The participants will receive the intervention OPL or EM over the duration of six weeks Diverse psychological and health measures will be assessed with questionnaires over the course of the intervention Furthermore evaluation outcomes qualitative outcomes and safety outcomes will be assessed It is hypothesized that the OLP-intervention group in comparison to the EM-control group will have a significantly lower consumption of MED over the course of the study Furthermore this study aims to evaluate whether the OLP intervention can reduce opioid withdrawal symptoms in comparison to the control group
Detailed Description:
CNCP is a major global health problem and is often treated with opiod medication although risks outweigh the benefits Therefore recent studies suggest that an open-label placebo OLP treatment the placebo treatment with full disclosure of being a placebo has proven to be an effective clinically relevant and evidence-based treatment in CNCP syndromes Furthermore a new line of research indicated that OLPs have been shown to be feasible for the reduction of active medication in opioid use disorder In line with the conditioning paradigm the drug as the unconditioned stimulus is paired with the neutral stimulus of an OLP in a learning phase Then the OLP alone becomes a conditioned stimulus
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PZ00P1_201972 | OTHER_GRANT | Swiss National Science Foundation | None |