Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-02-26 @ 11:00 AM
Study NCT ID:
NCT02362256
Status:
COMPLETED
Last Update Posted:
2015-02-12
First Post:
2015-01-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Comparison of Stress Response to Rapid Opioid Detoxification Applying Different Methods of Opioid Antagonism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009293', 'term': 'Opioid-Related Disorders'}], 'ancestors': [{'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009271', 'term': 'Naltrexone'}, {'id': 'C000624616', 'term': 'vivitrol'}, {'id': 'D003000', 'term': 'Clonidine'}, {'id': 'D008140', 'term': 'Lorazepam'}], 'ancestors': [{'id': 'D009270', 'term': 'Naloxone'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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'}, {'id': 'D048288', 'term': 'Imidazolines'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D001570', 'term': 'Benzodiazepinones'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-11', 'studyFirstSubmitDate': '2015-01-18', 'studyFirstSubmitQcDate': '2015-02-11', 'lastUpdatePostDateStruct': {'date': '2015-02-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cortisol levels', 'timeFrame': '2 days', 'description': 'Cortisol levels were assessed 4 times starting on intervention day (1 hour before intervention, 1, 5 and 23 hours post-intervention)'}, {'measure': 'Adrenocorticotropic hormone (ACTH) levels', 'timeFrame': '2 days', 'description': 'Cortisol levels were assessed 4 times starting on intervention day (1 hour before intervention, 1, 5 and 23 hours post-intervention)'}], 'secondaryOutcomes': [{'measure': 'Stress response levels according to heart rate', 'timeFrame': '4 days', 'description': 'Heart rate measurements were taken 4 times a day'}, {'measure': 'Stress response levels according to respiratory rate', 'timeFrame': '4 days', 'description': 'Respiratory rate measurements were taken 4 times a day'}, {'measure': 'Stress response levels according to blood pressure', 'timeFrame': '4 days', 'description': 'Blood pressure measurements were taken 4 times a day'}, {'measure': 'Changes of potassium concentration due to stress response', 'timeFrame': '4 days', 'description': 'Blood samples were taken 3 times a day'}, {'measure': 'Changes of sodium concentration due to stress response', 'timeFrame': '4 days', 'description': 'Blood samples were taken 3 times a day'}, {'measure': 'Changes of chloride concentration due to stress response', 'timeFrame': '4 days', 'description': 'Blood samples were taken 3 times a day'}, {'measure': 'Changes of magnesium concentration due to stress response', 'timeFrame': '4 days', 'description': 'Blood samples were taken 3 times a day'}, {'measure': 'Changes of glucose concentration due to stress response', 'timeFrame': '4 days', 'description': 'Blood samples were taken 3 times a day'}, {'measure': 'Subjective Opiate Withdrawal Scale (SOWS)', 'timeFrame': '4 days', 'description': 'Patients were assessed with to SOWS 4 times a day'}, {'measure': 'Objective Opiate Withdrawal Scale (OOWS)', 'timeFrame': '4 days', 'description': 'Patients were assessed with to OOWS 4 times a day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Opioid detoxification', 'Opioid antagonist induction', 'Conscious sedation'], 'conditions': ['Opiate Addiction']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate which method of naltrexone induction during rapid opioid detoxification causes stronger stress response and has a higher influence on opioid abstinence caused by opioid induction.', 'detailedDescription': 'Study enrolls opiate addicted patients who are motivated for a long term treatment and full opiate abstinence. Patient is offered to take part in a study. Information is provided regarding protocol, aim and course of study. Patients who are eligible and consent for study commit to follow the pre-study recommendations.\n\nStudy consists of:\n\nPrimary assessment - information about study. Assessment of patient according to predefined criteria. Consent form. Allocation of the treatment date.\n\nStabilization - Buprenorphine. Assessment according to SOWS and OWS. Total amount of buprenorphine is recorded.\n\nRepeated evaluation - patient after successful stabilization course undergoes urine test for psychotropic substances, blood alcohol level is recorded. If any test is positive patient is not enrolled to study.\n\nCorrection of opioid withdrawal symptoms - all of the patients receive medicines for opioid detoxification, infusion therapy in predefined doses.\n\nAntagonist induction - patients receive opioid antagonist (incremental or standard dose). Withdrawal symptoms are assessed and correction with lorazepam is given if needed.\n\nData collection - data is recorded (demographic, epidemiological, vital signs, opioid withdrawal symptoms, levels of hormones, metabolites, electrolytes).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Opiate addiction\n* Use of short-acting opiate (morphine or heroine)\n* Age \\> 18 years\n* Length of opiate addiction \\> 1 year\n* Patient can make a decision for detoxification and has a capacity to consent for procedure\n* Written consent for procedure\n\nExclusion Criteria:\n\n* Polyvalent addiction\n* Pregnancy or breast feeding\n* Cardiovascular pathology\n* Acute or chronic kidney disease\n* Decompensated liver pathology (jaundice, ascites, hepatic encephalopathy)\n* Infective complications of opiate addiction (pneumonia, phlegmon, abscess, thombophlebitis, sepsis)\n* Malnutrition (Nutritional risk screening 2002 score ≥3)\n* Diabetes mellitus\n* Previous history of psychosis\n* Glasgow coma scale \\< 15\n* Abdominal surgical intervention during last 30 days\n* Cumulative buprenorphine dose for stabilization \\< 8 mg\n* Positive test for psychoactive substances during treatment\n* Refusal to participate in study at any point of it'}, 'identificationModule': {'nctId': 'NCT02362256', 'briefTitle': 'The Comparison of Stress Response to Rapid Opioid Detoxification Applying Different Methods of Opioid Antagonism', 'organization': {'class': 'OTHER', 'fullName': 'Vilnius University'}, 'officialTitle': 'The Comparison of Stress Response to Rapid Opioid Detoxification Applying Different Methods of Opioid Antagonism With Naltrexone and Sedation', 'orgStudyIdInfo': {'id': '158200-01-443-124'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Opioid antagonist induction. Day 4. Duration 12-16 hours.\n\nNaltrexone gradual increase from 50 µg p/o to a total dose of 12,5 mg according to a predefined protocol:\n\n1. st hour 50 µg\n2. nd hour 50 µg\n3. rd hour 100 µg\n4. th hour 100 µg\n5. th hour 200 µg\n6. th hour 400 µg\n7. th hour 800 µg\n8. th hour 1600 µg\n9. th hour 3200 µg\n10. th hour 6000 µg\n\nCorrection of symptoms for opioid abstinence:\n\nClonidine 150 µg p/o every 4 hours (Day 3 and Day 4) Lorazepam 5 mg p/o every 4 hours (Day 3 and Day 4), Lorazepam 2,5 mg po every 4 hours (Day 5, Day 6)', 'interventionNames': ['Drug: Naltrexone', 'Drug: Clonidine', 'Drug: Lorazepam']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Opioid antagonist induction. Day 4. Duration 12-16 hours. Naltrexone single dose 12,5 mg p/o\n\nCorrection of symptoms for opioid abstinence:\n\nClonidine 150 µg p/o every 4 hours (Day 3 and Day 4) Lorazepam 5 mg p/o every 4 hours (Day 3 and Day 4), Lorazepam 2,5 mg po every 4 hours (Day 5, Day 6)', 'interventionNames': ['Drug: Naltrexone', 'Drug: Clonidine', 'Drug: Lorazepam']}], 'interventions': [{'name': 'Naltrexone', 'type': 'DRUG', 'otherNames': ['Vivitrol', 'Revia'], 'armGroupLabels': ['Control', 'Intervention']}, {'name': 'Clonidine', 'type': 'DRUG', 'otherNames': ['Catapres', 'Kapvay'], 'armGroupLabels': ['Control', 'Intervention']}, {'name': 'Lorazepam', 'type': 'DRUG', 'otherNames': ['Ativan'], 'armGroupLabels': ['Control', 'Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LT-04130', 'city': 'Vilnius', 'state': 'Vilnius County', 'country': 'Lithuania', 'facility': 'Republic Vilnius University Hospital', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}], 'overallOfficials': [{'name': 'ROBERTAS BADARAS, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vilnius University Clinic of Anaesthesiology and Intensive Care'}, {'name': 'JUOZAS IVASKEVICIUS, PROFESSOR', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Vilnius University Clinic of Anaesthesiology and Intensive Care'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vilnius University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD Robertas Badaras', 'investigatorFullName': 'Robertas Badaras', 'investigatorAffiliation': 'Vilnius University'}}}}