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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Signed Informed Consent

• ≥ 18 years of age

• German speaking

• Pain lasting ≥ 4 weeks, including subacute pain (4-12 weeks) and chronic pain (\>12 weeks)

• Opioid medication for pain management for ≥ 4 weeks

• Oral intake of opioid medication

• Motivation for opioid reduction

• Participants have a primary treating physician who performs the reduction of the opioid medication

• Having access to a computer or tablet with an email-account

Locations
Other Locations
Switzerland
University Hospital Zurich, Department of Consultation-Liaison Psychiatry and Psychosomatic Medicine
RECRUITING
Zurich
Contact Information
Primary
Cosima Locher, PhD
Cosima.Locher@usz.ch
+41 44 255 12 03
Backup
Kiara Bodonyi, MSc
Kiara.Bodonyi@usz.ch
+41 44 255 14 24
Time Frame
Start Date: 2024-06-12
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 86
Treatments
Experimental: Open-Label Placebo
The intervention involves administering P-Dragees blue Lichtenstein, blue placebo pills devoid of active ingredients. Each pill contains lactose monohydrate; magnesium stearate; microcrystalline cellulose; sucrose; glucose syrup; corn-starch; highly dispersed silicon dioxide; white clay; macrogol glycerol hydroxy stearate; Gum arabic; montanglycol wax; povidone; talcum; titanium dioxide; calcium carbonate; macrogol 6000; patent blue V; aluminium salt.~Participants receive an evidence-based rationale, explaining why the placebo treatment is deemed effective for pain. They are informed that the pills are placebos and are instructed to pair them with opioid medication for 7 days. After 7 days until the end of the study they are instructed to continue to pair their opioid medication with an OLP pill and take additionally placebo pills on the basis of their need. During the intervention, participants use electronic monitoring (EM) to track medication and OLP intakes.
Other: Electronic monitoring (EM) control group
EM is a method to objectively measure adherence and serves as the primary intervention component on the basis of which adherence trajectories will be discussed. The participants in the EM control group will receive an evidence-based rational designed to foster positive expectations and will be instructed on the mechanisms of EM.~The EM control group is structurally equivalent to the OLP group referring to the number and duration of contacts between participants and the study team members as well as to the format of the intervention and the quality of the interaction.
Related Therapeutic Areas
Sponsors
Collaborators: Brown University, University of Basel
Leads: Cosima Locher

This content was sourced from clinicaltrials.gov