Conditioned Open-label Placebos to Facilitate Opioid Reduction in Patients With Chronic Non-cancer Pain

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.

Conditions

• Chronic Non-cancer Pain

Interventions

OTHER

P-Dragees blue Lichtenstein, Placebo dragees

In the intervention group, open-label placebos are administered within the framework of a mind-body management intervention approach, which in turn is consistent with the biopsychosocial model of pain and with a patient-centred approach. The verbal interaction follows the four discussion points: 1. Opioids work by telling the body that participants are not experiencing as much pain; 2. Placebos should be taken every time an opioid is taken which supports the reduction of opioid medication (shown by previous studies); 3. By pairing the pills together the brain will learn to release chemicals like endorphins that cause pain-relief in response to the placebo, just as it does in response to the opioid; 4. At a certain point, placebos might provide adequate pain relief, and the participants might need less opioids.

OTHER

Control group (EM)

In the EM control group, the focus lies on the electronic monitoring (EM) of the opioid intake. The treatment rationale is designed to facilitate the reduction of opioid medication by promoting a positive attitude towards the implementation of the reduction. The verbal interaction follows the four discussion points: 1. The collection of EM data allows for greater patients' sense of agency over medication treatment; 2. Tracking of opioid medication use supports the reduction of opioid medication (shown by previous studies); 3. The EM is a useful tool, and daily recording of opioid medication intake should be done; 4. At a certain point, EM might provide adequate pain relief, and participants might need less opioids.

Sponsors & Collaborators

• Brown University

  collaborator OTHER

• University of Basel

  collaborator OTHER

• Cosima Locher

  lead OTHER

Principal Investigators

• Cosima Locher, PhD · USZ

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-06-12

Primary Completion

2026-05-31

Completion

2026-07-31

Countries

• Switzerland

Study Locations