Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 10:02 PM
Study NCT ID:
NCT05883358
Status:
RECRUITING
Last Update Posted:
2025-01-27
First Post:
2023-05-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Kratom Use Disorder Management Using Clonidine and/or Buprenorphine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013375', 'term': 'Substance Withdrawal Syndrome'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003000', 'term': 'Clonidine'}, {'id': 'D002047', 'term': 'Buprenorphine'}], 'ancestors': [{'id': 'D048288', 'term': 'Imidazolines'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-07-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-23', 'studyFirstSubmitDate': '2023-05-03', 'studyFirstSubmitQcDate': '2023-05-28', 'lastUpdatePostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Opiate Withdrawal Score', 'timeFrame': '12 weeks', 'description': 'Clinical Opiate Withdrawal Score on a scale of 5 to 36; low scores indicate mild withdrawal, high scores indicate severe withdrawal'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Kratom'], 'conditions': ['Withdrawal Syndrome']}, 'descriptionModule': {'briefSummary': 'Kratom is used for stimulant, analgesic, anxiolytic, and sedative effects. There is inadequate knowledge about Kratom addiction. Kratom withdrawal may be treated like opioid withdrawal.\n\nProspective observational crossover study of consenting adults who are undergoing Kratom withdrawal management. On alternate weeks, each patient receives treatment using Buprenorphine 5cmg/hr patch; or Clonidine tablet 0.1mg 4hourly; or combined Clonidine tablet 0.1mg 4hourly + Buprenorphine 5cmg/hr patch. Each patient will undergo treatment for 12 weeks.\n\nPatients will use Subjective Opiate Withdrawal Scale (SOWS) to collect data on daily basis. SOWS is a patient-administered tool that is used to record the severity and presence of opiate withdrawal. The physician will also use Clinical Opiate Withdrawal Scale (COWS) to collect data on weekly basis. COWS is a clinician-administered tool that is used to record the signs of opiate withdrawal. A change in the COWS and SOWS scores by 6-points is considered significant.', 'detailedDescription': "Kratom herb is used for stimulant, analgesic, anxiolytic, and sedative effects. There is inadequate knowledge about Kratom dependence and withdrawal therapy. Kratom withdrawal may be treated with similar therapy for opioid withdrawal.\n\nThis is a prospective observational crossover study of consenting adult patients who are undergoing Kratom withdrawal management. On alternate weeks, each patient receives rotational treatment using Buprenorphine 5cmg/hr patch; or Clonidine tablet 0.1mg 4hourly; or combined Clonidine tablet 0.1mg 4hourly + Buprenorphine 5cmg/hr patch. Each patient will undergo Kratom withdrawal treatment for 12 continuous weeks.\n\nThe patient will use the Subjective Opiate Withdrawal Scale (SOWS), a special validated scale, to collect data on daily basis. The SOWS is a patient-administered tool that is used to record the severity and presence of opiate withdrawal symptoms. In addition, the physician will use the Clinical Opiate Withdrawal Scale (COWS), a special validated scale, to collect data on weekly basis. The COWS is a clinician-administered tool that is used to record the symptoms and signs of opiate withdrawal or substance abuse disorder. A change in the COWS and SOWS scores by 6-points is considered significant.\n\nData analyzed with IBM® SPSS® Statistics 25 (IBM Corp, Armonk, NY); using Student's t-test, ANOVA, Pearson Chi-square test, and regression analysis. P-value \\<0.05 is considered significant."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients who have Kratom withdrawal syndrome; and undergoing medication treatment for Kratom withdrawal.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients\n* Kratom dependence\n* Kratom withdrawal syndrome\n* Kratom withdrawal therapy\n* good treatment compliance\n* reliable Subjective Opiate Withdrawal Scale (SOWS) diary\n* reliable Clinical Opiate Withdrawal Scale (COWS) diary\n* informed consent for diary review\n* consent for clinical record quality assurance review\n\nExclusion Criteria:\n\n* poor treatment compliance\n* cognitive disorder\n* inability to provide consent\n* major neuropsychiatric disorder\n* unreliable diary\n* cannabis use\n* excessive alcohol intake\n* previous adverse/allergic reactions to clonidine\n* previous adverse/allergic reactions to buprenorphine'}, 'identificationModule': {'nctId': 'NCT05883358', 'briefTitle': 'Kratom Use Disorder Management Using Clonidine and/or Buprenorphine', 'organization': {'class': 'OTHER', 'fullName': 'Salem Anaesthesia Pain Clinic'}, 'officialTitle': 'Kratom Use Disorder Management Using Clonidine and/or Buprenorphine', 'orgStudyIdInfo': {'id': 'SalemAnes2022 Kratom Addiction'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Kratom withdrawal', 'description': 'Kratom withdrawal syndrome patients, undergoing withdrawal therapy. On alternate weeks, each patient receives rotational treatment using Buprenorphine 5cmg/hr patch; or Clonidine tablet 0.1mg 4hourly; or combined Clonidine tablet 0.1mg 4hourly + Buprenorphine 5cmg/hr patch.', 'interventionNames': ['Drug: Clonidine, Buprenorphine']}], 'interventions': [{'name': 'Clonidine, Buprenorphine', 'type': 'DRUG', 'otherNames': ['Clonidine, Butrans'], 'description': 'Each patient receives rotational treatment using Buprenorphine 5cmg/hr patch; or Clonidine tablet 0.1mg 4hourly; or combined Clonidine tablet 0.1mg 4hourly + Buprenorphine 5cmg/hr patch.', 'armGroupLabels': ['Kratom withdrawal']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V3S 7J1', 'city': 'Surrey', 'state': 'British Columbia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Olu Bamgbade, MD,FRCPC', 'role': 'CONTACT', 'email': 'salem.painclinic@gmail.com', 'phone': '+17786286600'}], 'facility': 'Salem Anaesthesia Pain Clinic', 'geoPoint': {'lat': 49.10635, 'lon': -122.82509}}], 'centralContacts': [{'name': 'Olu Bamgbade, MD,FRCPC', 'role': 'CONTACT', 'email': 'salem.painclinic@gmail.com', 'phone': '17786286600'}], 'overallOfficials': [{'name': 'Olu Bamgbade, MD,FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Salem Anaesthesia Pain Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Salem Anaesthesia Pain Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}