Conditioned Open-label Placebos to Facilitate Opioid Reduction in Patients With Chronic Non-cancer Pain
NCT ID: NCT06350786
Last Updated: 2025-04-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
86 participants
INTERVENTIONAL
2024-06-12
2026-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Discontinuation vs Continuation of Long-term Opioid Therapy in Suboptimal and Optimal Responders With Chronic Pain
NCT02741076
Evaluating the Efficacy of Intranasal Oxytocin on Chronic Pain
NCT04903002
The Effect of Oxytocin on Placebo Analgesia: an Experimental Study in Healthy Volunteers
NCT01886014
Investigating Hope and Expectations in Open-Label Placebos
NCT03517644
Pain Response to Open Label Placebo in Induced Acute Pain in Healthy Male Adults
NCT03361579
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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 (Ph. Eur.); microcrystalline cellulose; sucrose; glucose syrup; corn-starch; highly dispersed silicon dioxide; white clay; macrogol glycerol hydroxy stearate (Ph. Eur.); Gum arabic; montanglycol wax; povidone (K 25); talcum; titanium dioxide (E 171); calcium carbonate; macrogol 6000; patent blue V; aluminium salt (E 131).
Participants will be informed that the pills are placebos and will be instructed to pair them with opioid medication for 7 days. After 7 days until the end of the study they will be instructed to continue to pair their opioid medication with an OLP pill and take additionally placebo pills on the basis of their need.
An evidence-based rationale will be provided, explaining why the placebo treatment is deemed effective for pain. This rationale will precede the OLP intake procedure.
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.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* ≥ 18 years of age
* German speaking
* Chronic non-cancer pain ≥ 6 months in duration
* Chronic opioid medication for \> 3 months
* 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
Exclusion Criteria
* Suicidality
* Cognitive impairment to everyday life
* Planned surgery within the next two months
* Known illegal drug or harmful alcohol consumption
* Intolerance of the ingredients of the placebo pill (e.g., lactose, sucrose, corn-starch)
* Serious health problems that make study participation impossible
* Simultaneous participation in other studies with investigational drugs or CNCP specific interventions
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Brown University
OTHER
University of Basel
OTHER
Cosima Locher
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Cosima Locher
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Cosima Locher, PhD
Role: PRINCIPAL_INVESTIGATOR
USZ
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Hospital Zurich, Department of Consultation-Liaison Psychiatry and Psychosomatic Medicine
Zurich, Canton of Zurich, Switzerland
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Buergler S, Sezer D, Gaab J, Locher C. The roles of expectation, comparator, administration route, and population in open-label placebo effects: a network meta-analysis. Sci Rep. 2023 Jul 22;13(1):11827. doi: 10.1038/s41598-023-39123-4.
Belcher AM, Cole TO, Massey E, Billing AS, Wagner M, Wooten W, Epstein DH, Hoag SW, Wickwire EM, Greenblatt AD, Colloca L, Rotrosen J, Magder L, Weintraub E, Wish ED, Kaptchuk TJ. Effectiveness of Conditioned Open-label Placebo With Methadone in Treatment of Opioid Use Disorder: A Randomized Clinical Trial. JAMA Netw Open. 2023 Apr 3;6(4):e237099. doi: 10.1001/jamanetworkopen.2023.7099.
Bernstein MH, Magill M, Weiss AP, Kaptchuk TJ, Blease C, Kirsch I, Rich JD, Becker SJ, Mach S, Beaudoin FL. Are Conditioned Open Placebos Feasible as an Adjunctive Treatment to Opioids? Results from a Single-Group Dose-Extender Pilot Study with Acute Pain Patients. Psychother Psychosom. 2019;88(6):380-382. doi: 10.1159/000503038. Epub 2019 Sep 27. No abstract available.
Estudillo-Guerra MA, Mesia-Toledo I, Schneider JC, Morales-Quezada L. The Use of Conditioning Open-Label Placebo in Opioid Dose Reduction: A Case Report and Literature Review. Front Pain Res (Lausanne). 2021 Jul 12;2:697475. doi: 10.3389/fpain.2021.697475. eCollection 2021.
Flowers KM, Patton ME, Hruschak VJ, Fields KG, Schwartz E, Zeballos J, Kang JD, Edwards RR, Kaptchuk TJ, Schreiber KL. Conditioned open-label placebo for opioid reduction after spine surgery: a randomized controlled trial. Pain. 2021 Jun 1;162(6):1828-1839. doi: 10.1097/j.pain.0000000000002185.
Morales-Quezada L, Mesia-Toledo I, Estudillo-Guerra A, O'Connor KC, Schneider JC, Sohn DJ, Crandell DM, Kaptchuk T, Zafonte R. Conditioning open-label placebo: a pilot pharmacobehavioral approach for opioid dose reduction and pain control. Pain Rep. 2020 Jul 20;5(4):e828. doi: 10.1097/PR9.0000000000000828. eCollection 2020 Jul-Aug.
Sezer D, de Leeuw M, Netzer C, Dieterle M, Meyer A, Buergler S, Locher C, Ruppen W, Gaab J, Schneider T. Open-Label Placebo Treatment for Acute Postoperative Pain (OLP-POP Study): Study Protocol of a Randomized Controlled Trial. Front Med (Lausanne). 2021 Nov 5;8:687398. doi: 10.3389/fmed.2021.687398. eCollection 2021.
Carratta K, Bodonyi K, Frey Nascimento A, Friis D, von Kanel R, Bircher L, Koechlin H, Bernstein M, Streitberger K, Arnet I, Roth AJ, Ronel J, Olliges E, Locher C. Conditioned open-label placebos to facilitate opioid reduction in patients with chronic non-cancer pain: study protocol of a randomised controlled trial. BMJ Open. 2025 May 24;15(5):e098253. doi: 10.1136/bmjopen-2024-098253.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PZ00P1_201972
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
ROM Study
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.