Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-01-01 @ 6:45 AM
Study NCT ID:
NCT06107595
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2023-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Conditioned Open Label Placebo for Postoperative Pain Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 222}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-27', 'studyFirstSubmitDate': '2023-10-18', 'studyFirstSubmitQcDate': '2023-10-24', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Opioids consumption', 'timeFrame': '17 days', 'description': 'Cumulative opioids intake as postoperative consumption (in MgMeq)'}], 'secondaryOutcomes': [{'measure': 'Time to Opioid withdrawal (in days)', 'timeFrame': 'until the 6 months follow-up', 'description': 'Time to Opioid withdrawal calculated for COLP compared to treatment as usual'}, {'measure': 'Postoperative pain intensity', 'timeFrame': '17 days', 'description': 'Daily Visual Analog Score from the e-diary (score from 0 to 10, 10=worst pain)'}, {'measure': 'Satisfaction with postoperative management', 'timeFrame': '17 days', 'description': 'Daily Visual Analog Score from the e-diary (score from 0 to 10, 10=highest satisfaction)'}, {'measure': 'Mobility', 'timeFrame': '17 days', 'description': 'Daily Visual Analog Score from the e-diary (score from 0 to 10, 10=best ability to move)'}, {'measure': 'Sense of agency', 'timeFrame': '17 days', 'description': 'Daily Visual Analog Score from the e-diary (score from 0 to 10, 10=best sense of agency)'}, {'measure': 'Side effects intensity', 'timeFrame': '17 days', 'description': 'Daily Visual Analog Score from the e-diary (score from 0 to 10, 10=worst intensity)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Postoperative']}, 'descriptionModule': {'briefSummary': 'The primary objective is to evaluate the efficacy of two Conditioned Open Label Placebos (COLP): COLP pill and COLP odor to reduce opioid intake for postoperative (thoracic and spinal surgery) pain management compared to the opioid only usual treatment (TAU).', 'detailedDescription': 'Patients, eligible for an elective thoracic or spinal surgery, will be randomized into either standard of care, COLP\\_pill or COLP\\_odor. Patients in COLP groups will be asked to pair each opioid intake with an open label placebo intake (either a pill or an inhalation) for postoperative (POD) day 0 to 17. From POD 2, patients in the intervention arms will be additionally asked to take OLP alone 3 times a day. Patients will have unrestricted access to pain killers. Patients will daily assess opioid intake, pain intensity, side effects, mobility and sense of agency using a e-dairy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Spinal or thoracic elective surgery for the indications mentioned above\n* Able to give informed consent\n* Interested in trying COLP as complementary pain management therapy\n* Able to fill a e-diary at home\n\nExclusion Criteria:\n\n* Cognitive impairment (MOCA score \\<26)\n* Inability to engage in the intervention of the study e.g. inability to communicate in French without a translator, severe hearing impairment without any hearing aid available at the time of intervention, anosmia or intolerance to eugenol.\n* Acute psychiatric (e.g. psychotic or suicidal ideation) or somatic (e.g. unstable cardio-respiratory condition) co-morbidity preventing full engagement during intervention\n* Opioid use disorder (toxicomania) or contraindication to pain management using opioids (allergy, refusal, ...)\n* Intolerance to placebo ingredients'}, 'identificationModule': {'nctId': 'NCT06107595', 'acronym': 'COLP', 'briefTitle': 'Conditioned Open Label Placebo for Postoperative Pain Management', 'organization': {'class': 'OTHER', 'fullName': 'Centre de Médecine Intégrative et Complémentaire (CEMIC)'}, 'officialTitle': 'A Randomized Controlled Trial Evaluating the Efficacy of Conditioned Open Label Placebo (COLP) to Limit Opioid Reliance for Postoperative Pain Management', 'orgStudyIdInfo': {'id': '2023-01664'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Efficacy of conditioned open label placebo pill', 'description': 'On postoperative day 0, participant will self-administer one OLP with all opioid analgesics (whether administered intravenously or orally). This pairing will be done from postoperative day 0 to postoperative day 17.\n\nStarting on postoperative day 2, participants take 3 scheduled placebo doses (pills or inhalation) every day, at 3 convenient times. In parallel, the OLP pairing to standard and rescue doses of opioids will continue.\n\nThe patients are told to continue taking both scheduled standalone COLP and paired COLP (if needed) until postoperative day 17.', 'interventionNames': ['Behavioral: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Efficacy of conditioned open label placebo odor', 'description': '1 drops of clove oil (i.e. eugenol) will be disposed on a cotton and inserted into a stick. The patients will be asked to actively smell them by sniffing using a stick of inhalation. On postoperative day 0, participant will self-administer one OLP with all opioid analgesics (whether administered intravenously or orally). This pairing will be done from postoperative day 0 to postoperative day 17.\n\nOn postoperative day 2, participants take 3 scheduled placebo doses (pills or inhalation) every day, at 3 convenient times. In parallel, the OLP pairing to standard and rescue doses of opioids will continue.\n\nThe patients are told to continue taking both scheduled standalone COLP and paired COLP (if needed) until postoperative day 17', 'interventionNames': ['Behavioral: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of care', 'description': 'Usual postoperative pain management, relying mainly on opioids', 'interventionNames': ['Behavioral: Placebo']}], 'interventions': [{'name': 'Placebo', 'type': 'BEHAVIORAL', 'description': 'Participant take 1 dose placebo (odor or pill) on post-op day 0 (POD 0) and 3 placebo dose from POD 2 to POD 17', 'armGroupLabels': ['Efficacy of conditioned open label placebo odor', 'Efficacy of conditioned open label placebo pill', 'Standard of care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1011', 'city': 'Lausanne', 'state': 'Canton of Vaud', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Aurore Fernandez', 'role': 'CONTACT', 'email': 'aurore.fernandez@chuv.ch', 'phone': '079 556 66 91'}], 'facility': "Centre de Médecine Intégrative et Complémentaire, Service d'anesthésiologie, CHUV,", 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'centralContacts': [{'name': 'Aurore Fernandez, PhD', 'role': 'CONTACT', 'email': 'aurore.fernandez@chuv.ch', 'phone': '+41 79 556 66 91\u202c'}], 'overallOfficials': [{'name': 'Chantal Berna Renella, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre de Médecine Intégrative et Complémentaire, Lausanne University hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre de Médecine Intégrative et Complémentaire (CEMIC)', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Chantal Berna Renella', 'investigatorAffiliation': 'Centre de Médecine Intégrative et Complémentaire (CEMIC)'}}}}