Conditioned Open-label Placebos to Facilitate Opioid Reduction in Patients With Subacute or Chronic Pain Pain: a Randomized Controlled Trial

Condition(s) studied

Investigational drug(s) / intervention(s)

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. In addition, during the intervention, participants use electronic monitoring (EM) to track medication and OLP intakes.

Control group (EM): In the EM control group, the focus lies on the electronic monitoring 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.

Study summary

This study aims to evaluate whether the reduction of the daily morphine equivalent dose (MED) in patients with subacute and chronic pain 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.

Eligibility

Primary outcome measure(s)

• Daily opioid consumption (MED): — Daily measure: starts on day 1 after the first intervention visit (baseline, day 0) after randomization and ends on day 42 at the end of the study.
  Cumulative dose (i.e. total amount) of opioid pain medication consumption based on daily morphine equivalent doses (MED). Data is collected in SEMA3 app.

Trial sites (1)

Other trials for the same condition