Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2026-01-17 @ 1:02 AM
Study NCT ID:
NCT02851303
Status:
COMPLETED
Last Update Posted:
2023-05-24
First Post:
2016-07-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Morphine Versus Methadone for Opiate Exposed Infants With Neonatal Abstinence Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009357', 'term': 'Neonatal Abstinence Syndrome'}], 'ancestors': [{'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009020', 'term': 'Morphine'}, {'id': 'D008691', 'term': 'Methadone'}], 'ancestors': [{'id': 'D009022', 'term': 'Morphine Derivatives'}, {'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': 'D007659', 'term': 'Ketones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'marybeth_sutter@brown.edu', 'phone': '401-921-7981', 'title': 'Dr. Mary Beth Sutter', 'organization': 'Brown Family Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Collected during initial hospitalization following birth for entire length of hospital stay on infants of dyads only. No infant adverse events following hospital discharge were collected. No maternal adverse events were examined/collected.', 'eventGroups': [{'id': 'EG000', 'title': 'Morphine', 'description': 'Dose given q 3 - 4 hrs with feeds; do not exceed 4 hrs between doses Morphine (0.04mg/0.1ml)\n\nScore Dose For Initiation 0-8 0 None 9-12 0.04 mg/dose 13-16 0.08 mg/dose 17-20 0.12 mg/dose 21-24 0.16 mg/dose 25 or above 0.20mg/dose\n\nMorphine Maintenance/Escalation\n\n* Maintain dose if score 0-8\n* Increase dose by 0.02 if score is 9-12 (rescore before dosing) • Increase dose by 0.04 if score 13-16\n* Increase score by 0.06 if score 17-20\n\nWeaning Instructions:\n\n* Maintain on dose 48 hrs before starting weaning\n* Wean 0.02 mg morphine every day for a score is 0-8 • Defer wean for score 9-12\n\nRe-escalation\n\n* If neonate scores 9-12 re-score as described for initiation,\n* If second score is in 9-12 increase morphine 0.01 mg q3-4 hrs • If 2 consecutive scores 13-16, increase 0.02 mg q3-4 hrs\n* If 2 consecutive scores in 17-20, increase 0.04 mg q3-4 hrs etc\n\nMorphine: Morphine wean protocol as described in arm description\n\nAdverse events were recorded only for infants of each dyad.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Methadone', 'description': 'Step 1: 0.7 mgs/Kg/24 hrs. divided by into six doses (q 4 hrs) is starting dose Step 2: Decrease dose by half, which is 50% of starting dose, EVERY 4 hours. Step 3: Same dose which is 50% of starting dose EVERY 6 hours. Step 4: Same dose which is 50% of starting dose EVERY 8 hours. Step 5: Same dose which is 50% of starting dose EVERY 12 hours. Step 6: Decrease dose by half, which is 25% of starting dose EVERY 12 hours. Step 7: Same dose which is 25% of starting dose q 24 hours\n\nMethadone: Methadone wean protocol as described in arm description\n\nAdverse events were recorded only for infants of each dyad.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 3, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'High level of care transfer', 'notes': 'Baby had to be transferred to higher level of care for over sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Length of Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Morphine', 'description': 'Dose given q 3 - 4 hrs with feeds; do not exceed 4 hrs between doses Morphine (0.04mg/0.1ml)\n\nScore Dose For Initiation 0-8 0 None 9-12 0.04 mg/dose 13-16 0.08 mg/dose 17-20 0.12 mg/dose 21-24 0.16 mg/dose 25 or above 0.20mg/dose\n\nMorphine Maintenance/Escalation\n\n* Maintain dose if score 0-8\n* Increase dose by 0.02 if score is 9-12 (rescore before dosing) • Increase dose by 0.04 if score 13-16\n* Increase score by 0.06 if score 17-20\n\nWeaning Instructions:\n\n* Maintain on dose 48 hrs before starting weaning\n* Wean 0.02 mg morphine every day for a score is 0-8 • Defer wean for score 9-12\n\nRe-escalation\n\n* If neonate scores 9-12 re-score as described for initiation,\n* If second score is in 9-12 increase morphine 0.01 mg q3-4 hrs • If 2 consecutive scores 13-16, increase 0.02 mg q3-4 hrs\n* If 2 consecutive scores in 17-20, increase 0.04 mg q3-4 hrs etc\n\nMorphine: Morphine wean protocol as described in arm description'}, {'id': 'OG001', 'title': 'Methadone', 'description': 'Step 1: 0.7 mgs/Kg/24 hrs. divided by into six doses (q 4 hrs) is starting dose Step 2: Decrease dose by half, which is 50% of starting dose, EVERY 4 hours. Step 3: Same dose which is 50% of starting dose EVERY 6 hours. Step 4: Same dose which is 50% of starting dose EVERY 8 hours. Step 5: Same dose which is 50% of starting dose EVERY 12 hours. Step 6: Decrease dose by half, which is 25% of starting dose EVERY 12 hours. Step 7: Same dose which is 25% of starting dose q 24 hours\n\nMethadone: Methadone wean protocol as described in arm description'}], 'classes': [{'categories': [{'measurements': [{'value': '17.9', 'spread': '8.6', 'groupId': 'OG000'}, {'value': '16.1', 'spread': '4.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'assessed at hospital discharge, approximately 7-30 days', 'description': 'Number of days in hospital after birth', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Morphine', 'description': 'Dose given q 3 - 4 hrs with feeds; do not exceed 4 hrs between doses Morphine (0.04mg/0.1ml)\n\nScore Dose For Initiation 0-8 0 None 9-12 0.04 mg/dose 13-16 0.08 mg/dose 17-20 0.12 mg/dose 21-24 0.16 mg/dose 25 or above 0.20mg/dose\n\nMorphine Maintenance/Escalation\n\n* Maintain dose if score 0-8\n* Increase dose by 0.02 if score is 9-12 (rescore before dosing) • Increase dose by 0.04 if score 13-16\n* Increase score by 0.06 if score 17-20\n\nWeaning Instructions:\n\n* Maintain on dose 48 hrs before starting weaning\n* Wean 0.02 mg morphine every day for a score is 0-8 • Defer wean for score 9-12\n\nRe-escalation\n\n* If neonate scores 9-12 re-score as described for initiation,\n* If second score is in 9-12 increase morphine 0.01 mg q3-4 hrs • If 2 consecutive scores 13-16, increase 0.02 mg q3-4 hrs\n* If 2 consecutive scores in 17-20, increase 0.04 mg q3-4 hrs etc\n\nMorphine: Morphine wean protocol as described in arm description'}, {'id': 'OG001', 'title': 'Methadone', 'description': 'Step 1: 0.7 mgs/Kg/24 hrs. divided by into six doses (q 4 hrs) is starting dose Step 2: Decrease dose by half, which is 50% of starting dose, EVERY 4 hours. Step 3: Same dose which is 50% of starting dose EVERY 6 hours. Step 4: Same dose which is 50% of starting dose EVERY 8 hours. Step 5: Same dose which is 50% of starting dose EVERY 12 hours. Step 6: Decrease dose by half, which is 25% of starting dose EVERY 12 hours. Step 7: Same dose which is 25% of starting dose q 24 hours\n\nMethadone: Methadone wean protocol as described in arm description'}], 'classes': [{'categories': [{'measurements': [{'value': '14.7', 'spread': '9.9', 'groupId': 'OG000'}, {'value': '12.8', 'spread': '5.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'assessed at hospital discharge, approximately 7-30 days', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Need for Additional Agent to Treat Withdrawal, Determined by Chart Review of Medication Administration Record of Administered Medications for Withdrawal Treatment (Example: Clonidine or Phenobarbital)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Morphine', 'description': 'Dose given q 3 - 4 hrs with feeds; do not exceed 4 hrs between doses Morphine (0.04mg/0.1ml)\n\nScore Dose For Initiation 0-8 0 None 9-12 0.04 mg/dose 13-16 0.08 mg/dose 17-20 0.12 mg/dose 21-24 0.16 mg/dose 25 or above 0.20mg/dose\n\nMorphine Maintenance/Escalation\n\n* Maintain dose if score 0-8\n* Increase dose by 0.02 if score is 9-12 (rescore before dosing) • Increase dose by 0.04 if score 13-16\n* Increase score by 0.06 if score 17-20\n\nWeaning Instructions:\n\n* Maintain on dose 48 hrs before starting weaning\n* Wean 0.02 mg morphine every day for a score is 0-8 • Defer wean for score 9-12\n\nRe-escalation\n\n* If neonate scores 9-12 re-score as described for initiation,\n* If second score is in 9-12 increase morphine 0.01 mg q3-4 hrs • If 2 consecutive scores 13-16, increase 0.02 mg q3-4 hrs\n* If 2 consecutive scores in 17-20, increase 0.04 mg q3-4 hrs etc\n\nMorphine: Morphine wean protocol as described in arm description'}, {'id': 'OG001', 'title': 'Methadone', 'description': 'Step 1: 0.7 mgs/Kg/24 hrs. divided by into six doses (q 4 hrs) is starting dose Step 2: Decrease dose by half, which is 50% of starting dose, EVERY 4 hours. Step 3: Same dose which is 50% of starting dose EVERY 6 hours. Step 4: Same dose which is 50% of starting dose EVERY 8 hours. Step 5: Same dose which is 50% of starting dose EVERY 12 hours. Step 6: Decrease dose by half, which is 25% of starting dose EVERY 12 hours. Step 7: Same dose which is 25% of starting dose q 24 hours\n\nMethadone: Methadone wean protocol as described in arm description'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'assessed at hospital discharge, approximately 7-30 days', 'description': 'clonidine', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Need for Feeding Assistance, Determined by Chart Review of Discharge Summary, Specifically Evaluating for Need for Nasogastric Tube Placement or Peripheral Parenteral Nutrition.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Morphine', 'description': 'Dose given q 3 - 4 hrs with feeds; do not exceed 4 hrs between doses Morphine (0.04mg/0.1ml)\n\nScore Dose For Initiation 0-8 0 None 9-12 0.04 mg/dose 13-16 0.08 mg/dose 17-20 0.12 mg/dose 21-24 0.16 mg/dose 25 or above 0.20mg/dose\n\nMorphine Maintenance/Escalation\n\n* Maintain dose if score 0-8\n* Increase dose by 0.02 if score is 9-12 (rescore before dosing) • Increase dose by 0.04 if score 13-16\n* Increase score by 0.06 if score 17-20\n\nWeaning Instructions:\n\n* Maintain on dose 48 hrs before starting weaning\n* Wean 0.02 mg morphine every day for a score is 0-8 • Defer wean for score 9-12\n\nRe-escalation\n\n* If neonate scores 9-12 re-score as described for initiation,\n* If second score is in 9-12 increase morphine 0.01 mg q3-4 hrs • If 2 consecutive scores 13-16, increase 0.02 mg q3-4 hrs\n* If 2 consecutive scores in 17-20, increase 0.04 mg q3-4 hrs etc\n\nMorphine: Morphine wean protocol as described in arm description'}, {'id': 'OG001', 'title': 'Methadone', 'description': 'Step 1: 0.7 mgs/Kg/24 hrs. divided by into six doses (q 4 hrs) is starting dose Step 2: Decrease dose by half, which is 50% of starting dose, EVERY 4 hours. Step 3: Same dose which is 50% of starting dose EVERY 6 hours. Step 4: Same dose which is 50% of starting dose EVERY 8 hours. Step 5: Same dose which is 50% of starting dose EVERY 12 hours. Step 6: Decrease dose by half, which is 25% of starting dose EVERY 12 hours. Step 7: Same dose which is 25% of starting dose q 24 hours\n\nMethadone: Methadone wean protocol as described in arm description'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'assessed at hospital discharge, approximately 7-30 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Need for NICU Transfer, as Determined by Chart Review of Discharge Summary.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Morphine', 'description': 'Dose given q 3 - 4 hrs with feeds; do not exceed 4 hrs between doses Morphine (0.04mg/0.1ml)\n\nScore Dose For Initiation 0-8 0 None 9-12 0.04 mg/dose 13-16 0.08 mg/dose 17-20 0.12 mg/dose 21-24 0.16 mg/dose 25 or above 0.20mg/dose\n\nMorphine Maintenance/Escalation\n\n* Maintain dose if score 0-8\n* Increase dose by 0.02 if score is 9-12 (rescore before dosing) • Increase dose by 0.04 if score 13-16\n* Increase score by 0.06 if score 17-20\n\nWeaning Instructions:\n\n* Maintain on dose 48 hrs before starting weaning\n* Wean 0.02 mg morphine every day for a score is 0-8 • Defer wean for score 9-12\n\nRe-escalation\n\n* If neonate scores 9-12 re-score as described for initiation,\n* If second score is in 9-12 increase morphine 0.01 mg q3-4 hrs • If 2 consecutive scores 13-16, increase 0.02 mg q3-4 hrs\n* If 2 consecutive scores in 17-20, increase 0.04 mg q3-4 hrs etc\n\nMorphine: Morphine wean protocol as described in arm description'}, {'id': 'OG001', 'title': 'Methadone', 'description': 'Step 1: 0.7 mgs/Kg/24 hrs. divided by into six doses (q 4 hrs) is starting dose Step 2: Decrease dose by half, which is 50% of starting dose, EVERY 4 hours. Step 3: Same dose which is 50% of starting dose EVERY 6 hours. Step 4: Same dose which is 50% of starting dose EVERY 8 hours. Step 5: Same dose which is 50% of starting dose EVERY 12 hours. Step 6: Decrease dose by half, which is 25% of starting dose EVERY 12 hours. Step 7: Same dose which is 25% of starting dose q 24 hours\n\nMethadone: Methadone wean protocol as described in arm description'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'assessed at hospital discharge, approximately 7-30 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Breastfeeding Initiation and Continuation at Hospital Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Morphine', 'description': 'Dose given q 3 - 4 hrs with feeds; do not exceed 4 hrs between doses Morphine (0.04mg/0.1ml)\n\nScore Dose For Initiation 0-8 0 None 9-12 0.04 mg/dose 13-16 0.08 mg/dose 17-20 0.12 mg/dose 21-24 0.16 mg/dose 25 or above 0.20mg/dose\n\nMorphine Maintenance/Escalation\n\n* Maintain dose if score 0-8\n* Increase dose by 0.02 if score is 9-12 (rescore before dosing) • Increase dose by 0.04 if score 13-16\n* Increase score by 0.06 if score 17-20\n\nWeaning Instructions:\n\n* Maintain on dose 48 hrs before starting weaning\n* Wean 0.02 mg morphine every day for a score is 0-8 • Defer wean for score 9-12\n\nRe-escalation\n\n* If neonate scores 9-12 re-score as described for initiation,\n* If second score is in 9-12 increase morphine 0.01 mg q3-4 hrs • If 2 consecutive scores 13-16, increase 0.02 mg q3-4 hrs\n* If 2 consecutive scores in 17-20, increase 0.04 mg q3-4 hrs etc\n\nMorphine: Morphine wean protocol as described in arm description'}, {'id': 'OG001', 'title': 'Methadone', 'description': 'Step 1: 0.7 mgs/Kg/24 hrs. divided by into six doses (q 4 hrs) is starting dose Step 2: Decrease dose by half, which is 50% of starting dose, EVERY 4 hours. Step 3: Same dose which is 50% of starting dose EVERY 6 hours. Step 4: Same dose which is 50% of starting dose EVERY 8 hours. Step 5: Same dose which is 50% of starting dose EVERY 12 hours. Step 6: Decrease dose by half, which is 25% of starting dose EVERY 12 hours. Step 7: Same dose which is 25% of starting dose q 24 hours\n\nMethadone: Methadone wean protocol as described in arm description'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'assessed at hospital discharge, approximately 7-30 days', 'description': 'Assessed through chart review of discharge summary documentation of method of infant feeding at time of discharge', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Morphine Equivalent Dose Received', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Morphine', 'description': 'Dose given q 3 - 4 hrs with feeds; do not exceed 4 hrs between doses Morphine (0.04mg/0.1ml)\n\nScore Dose For Initiation 0-8 0 None 9-12 0.04 mg/dose 13-16 0.08 mg/dose 17-20 0.12 mg/dose 21-24 0.16 mg/dose 25 or above 0.20mg/dose\n\nMorphine Maintenance/Escalation\n\n* Maintain dose if score 0-8\n* Increase dose by 0.02 if score is 9-12 (rescore before dosing) • Increase dose by 0.04 if score 13-16\n* Increase score by 0.06 if score 17-20\n\nWeaning Instructions:\n\n* Maintain on dose 48 hrs before starting weaning\n* Wean 0.02 mg morphine every day for a score is 0-8 • Defer wean for score 9-12\n\nRe-escalation\n\n* If neonate scores 9-12 re-score as described for initiation,\n* If second score is in 9-12 increase morphine 0.01 mg q3-4 hrs • If 2 consecutive scores 13-16, increase 0.02 mg q3-4 hrs\n* If 2 consecutive scores in 17-20, increase 0.04 mg q3-4 hrs etc\n\nMorphine: Morphine wean protocol as described in arm description'}, {'id': 'OG001', 'title': 'Methadone', 'description': 'Step 1: 0.7 mgs/Kg/24 hrs. divided by into six doses (q 4 hrs) is starting dose Step 2: Decrease dose by half, which is 50% of starting dose, EVERY 4 hours. Step 3: Same dose which is 50% of starting dose EVERY 6 hours. Step 4: Same dose which is 50% of starting dose EVERY 8 hours. Step 5: Same dose which is 50% of starting dose EVERY 12 hours. Step 6: Decrease dose by half, which is 25% of starting dose EVERY 12 hours. Step 7: Same dose which is 25% of starting dose q 24 hours\n\nMethadone: Methadone wean protocol as described in arm description'}], 'classes': [{'categories': [{'measurements': [{'value': '9.86', 'spread': '12.92', 'groupId': 'OG000'}, {'value': '33.0', 'spread': '17.49', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'assessed at hospital discharge, approximately 7-30 days', 'unitOfMeasure': 'morphine equivalents mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Morphine', 'description': 'Dose given q 3 - 4 hrs with feeds; do not exceed 4 hrs between doses Morphine (0.04mg/0.1ml)\n\nScore Dose For Initiation 0-8 0 None 9-12 0.04 mg/dose 13-16 0.08 mg/dose 17-20 0.12 mg/dose 21-24 0.16 mg/dose 25 or above 0.20mg/dose\n\nMorphine Maintenance/Escalation\n\n* Maintain dose if score 0-8\n* Increase dose by 0.02 if score is 9-12 (rescore before dosing) • Increase dose by 0.04 if score 13-16\n* Increase score by 0.06 if score 17-20\n\nWeaning Instructions:\n\n* Maintain on dose 48 hrs before starting weaning\n* Wean 0.02 mg morphine every day for a score is 0-8 • Defer wean for score 9-12\n\nRe-escalation\n\n* If neonate scores 9-12 re-score as described for initiation,\n* If second score is in 9-12 increase morphine 0.01 mg q3-4 hrs • If 2 consecutive scores 13-16, increase 0.02 mg q3-4 hrs\n* If 2 consecutive scores in 17-20, increase 0.04 mg q3-4 hrs etc\n\nMorphine: Morphine wean protocol as described in arm description'}, {'id': 'FG001', 'title': 'Methadone', 'description': 'Step 1: 0.7 mgs/Kg/24 hrs. divided by into six doses (q 4 hrs) is starting dose Step 2: Decrease dose by half, which is 50% of starting dose, EVERY 4 hours. Step 3: Same dose which is 50% of starting dose EVERY 6 hours. Step 4: Same dose which is 50% of starting dose EVERY 8 hours. Step 5: Same dose which is 50% of starting dose EVERY 12 hours. Step 6: Decrease dose by half, which is 25% of starting dose EVERY 12 hours. Step 7: Same dose which is 25% of starting dose q 24 hours\n\nMethadone: Methadone wean protocol as described in arm description'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Parent-Infant Dyads', 'groupId': 'FG000', 'numSubjects': '15'}, {'comment': 'Parent-Infant Dyads', 'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Parent-Infant Dyads', 'groupId': 'FG000', 'numSubjects': '15'}, {'comment': 'Parent-Infant Dyads', 'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Participants were enrolled as dyads during the initial birth hospitalization. Randomization occured at the time of consent to allow for pharmacologic treatment to begin whenever it was deemed medically necessary without the time constraint of needing randomization by the research team. As not all infants required pharmacologic treatment for withdrawal, they dropped out of the study arm.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Morphine', 'description': 'Dose given q 3 - 4 hrs with feeds; do not exceed 4 hrs between doses Morphine (0.04mg/0.1ml)\n\nScore Dose For Initiation 0-8 0 None 9-12 0.04 mg/dose 13-16 0.08 mg/dose 17-20 0.12 mg/dose 21-24 0.16 mg/dose 25 or above 0.20mg/dose\n\nMorphine Maintenance/Escalation\n\n* Maintain dose if score 0-8\n* Increase dose by 0.02 if score is 9-12 (rescore before dosing) • Increase dose by 0.04 if score 13-16\n* Increase score by 0.06 if score 17-20\n\nWeaning Instructions:\n\n* Maintain on dose 48 hrs before starting weaning\n* Wean 0.02 mg morphine every day for a score is 0-8 • Defer wean for score 9-12\n\nRe-escalation\n\n* If neonate scores 9-12 re-score as described for initiation,\n* If second score is in 9-12 increase morphine 0.01 mg q3-4 hrs • If 2 consecutive scores 13-16, increase 0.02 mg q3-4 hrs\n* If 2 consecutive scores in 17-20, increase 0.04 mg q3-4 hrs etc\n\nMorphine: Morphine wean protocol as described in arm description'}, {'id': 'BG001', 'title': 'Methadone', 'description': 'Step 1: 0.7 mgs/Kg/24 hrs. divided by into six doses (q 4 hrs) is starting dose Step 2: Decrease dose by half, which is 50% of starting dose, EVERY 4 hours. Step 3: Same dose which is 50% of starting dose EVERY 6 hours. Step 4: Same dose which is 50% of starting dose EVERY 8 hours. Step 5: Same dose which is 50% of starting dose EVERY 12 hours. Step 6: Decrease dose by half, which is 25% of starting dose EVERY 12 hours. Step 7: Same dose which is 25% of starting dose q 24 hours\n\nMethadone: Methadone wean protocol as described in arm description'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.7', 'spread': '1.7', 'groupId': 'BG000'}, {'value': '37.5', 'spread': '1.2', 'groupId': 'BG001'}, {'value': '37.6', 'spread': '1.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Gestational age of infant component of the dyad at birth', 'unitOfMeasure': 'weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': 'Mean age', 'categories': [{'measurements': [{'value': '27.8', 'spread': '4.3', 'groupId': 'BG000'}, {'value': '25.4', 'spread': '3.1', 'groupId': 'BG001'}, {'value': '26.68', 'spread': '3.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Age of parent component of the dyad', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Reflects parent component of dyad', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White non-hispanic', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'hispanic', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'native american', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Reflects parent component of dyad', 'unitOfMeasure': 'Participants'}, {'title': 'Initiation of prenatal care in first trimester', 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Reflects parent component of dyad', 'unitOfMeasure': 'Participants'}, {'title': 'Concurrent illicit opioid use', 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Reflects parent component of dyad', 'unitOfMeasure': 'Participants'}, {'title': 'Concurrent tobacco use', 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Reflects parent component of dyad', 'unitOfMeasure': 'Participants'}, {'title': 'Concurrent methamphetamine use', 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Reflects parent component of dyad', 'unitOfMeasure': 'Participants'}, {'title': 'Concurrent benzodiazepine use', 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Reflects parent component of dyad', 'unitOfMeasure': 'Participants'}, {'title': 'Concurrent alcohol use', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Reflects parent component of dyad', 'unitOfMeasure': 'Participants'}, {'title': 'Concurrent SSRI', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Reflects parent component of dyad', 'unitOfMeasure': 'Participants'}, {'title': 'Preterm delivery', 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Reflects parent component of dyad/ birth gestational age of infant component of dyad', 'unitOfMeasure': 'Participants'}, {'title': 'Maternal gestational diabetes', 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Reflects parent component of dyad', 'unitOfMeasure': 'Participants'}, {'title': 'Maternal preeclampsia', 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Reflects parent component of dyad', 'unitOfMeasure': 'Participants'}], 'populationDescription': '28 out of 61 randomized required pharmacologic therapy for withdrawal. Participant number reflects dyad pairs. Data collected from parent and or infant as described in footnotes for each item. Data were not collected for infants on items other than gestational age at birth.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-04-09', 'size': 343961, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-02-14T22:57', 'hasProtocol': True}, {'date': '2018-04-09', 'size': 79146, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-02-14T22:53', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2018-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-22', 'studyFirstSubmitDate': '2016-07-19', 'resultsFirstSubmitDate': '2022-02-15', 'studyFirstSubmitQcDate': '2016-07-27', 'lastUpdatePostDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-05-22', 'studyFirstPostDateStruct': {'date': '2016-08-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of Hospital Stay', 'timeFrame': 'assessed at hospital discharge, approximately 7-30 days', 'description': 'Number of days in hospital after birth'}], 'secondaryOutcomes': [{'measure': 'Length of Treatment', 'timeFrame': 'assessed at hospital discharge, approximately 7-30 days'}, {'measure': 'Need for Additional Agent to Treat Withdrawal, Determined by Chart Review of Medication Administration Record of Administered Medications for Withdrawal Treatment (Example: Clonidine or Phenobarbital)', 'timeFrame': 'assessed at hospital discharge, approximately 7-30 days', 'description': 'clonidine'}, {'measure': 'Need for Feeding Assistance, Determined by Chart Review of Discharge Summary, Specifically Evaluating for Need for Nasogastric Tube Placement or Peripheral Parenteral Nutrition.', 'timeFrame': 'assessed at hospital discharge, approximately 7-30 days'}, {'measure': 'Need for NICU Transfer, as Determined by Chart Review of Discharge Summary.', 'timeFrame': 'assessed at hospital discharge, approximately 7-30 days'}, {'measure': 'Breastfeeding Initiation and Continuation at Hospital Discharge', 'timeFrame': 'assessed at hospital discharge, approximately 7-30 days', 'description': 'Assessed through chart review of discharge summary documentation of method of infant feeding at time of discharge'}, {'measure': 'Total Morphine Equivalent Dose Received', 'timeFrame': 'assessed at hospital discharge, approximately 7-30 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Neonatal Abstinence Syndrome']}, 'referencesModule': {'references': [{'pmid': '22291123', 'type': 'BACKGROUND', 'citation': 'Hudak ML, Tan RC; COMMITTEE ON DRUGS; COMMITTEE ON FETUS AND NEWBORN; American Academy of Pediatrics. Neonatal drug withdrawal. Pediatrics. 2012 Feb;129(2):e540-60. doi: 10.1542/peds.2011-3212. Epub 2012 Jan 30.'}, {'pmid': '25927272', 'type': 'BACKGROUND', 'citation': 'Patrick SW, Davis MM, Lehmann CU, Cooper WO. Increasing incidence and geographic distribution of neonatal abstinence syndrome: United States 2009 to 2012. J Perinatol. 2015 Aug;35(8):650-5. doi: 10.1038/jp.2015.36. Epub 2015 Apr 30.'}, {'pmid': '25070317', 'type': 'BACKGROUND', 'citation': 'Hall ES, Wexelblatt SL, Crowley M, Grow JL, Jasin LR, Klebanoff MA, McClead RE, Meinzen-Derr J, Mohan VK, Stein H, Walsh MC; OCHNAS Consortium. A multicenter cohort study of treatments and hospital outcomes in neonatal abstinence syndrome. Pediatrics. 2014 Aug;134(2):e527-34. doi: 10.1542/peds.2013-4036.'}, {'pmid': '7000060', 'type': 'BACKGROUND', 'citation': 'Winter M, Nelson DS, Milton GW. Leucocyte adherence inhibition test for the detection of cell-mediated immunity to malignant melanoma. Aust N Z J Med. 1980 Aug;10(4):405-9. doi: 10.1111/j.1445-5994.1980.tb04090.x.'}, {'pmid': '23314720', 'type': 'BACKGROUND', 'citation': 'Logan BA, Brown MS, Hayes MJ. Neonatal abstinence syndrome: treatment and pediatric outcomes. Clin Obstet Gynecol. 2013 Mar;56(1):186-92. doi: 10.1097/GRF.0b013e31827feea4.'}, {'pmid': '26371196', 'type': 'BACKGROUND', 'citation': 'Hall ES, Wexelblatt SL, Crowley M, Grow JL, Jasin LR, Klebanoff MA, McClead RE, Meinzen-Derr J, Mohan VK, Stein H, Walsh MC; OCHNAS Consortium. Implementation of a Neonatal Abstinence Syndrome Weaning Protocol: A Multicenter Cohort Study. Pediatrics. 2015 Oct;136(4):e803-10. doi: 10.1542/peds.2015-1141. Epub 2015 Sep 14.'}, {'pmid': '21142534', 'type': 'BACKGROUND', 'citation': "Jones HE, Kaltenbach K, Heil SH, Stine SM, Coyle MG, Arria AM, O'Grady KE, Selby P, Martin PR, Fischer G. Neonatal abstinence syndrome after methadone or buprenorphine exposure. N Engl J Med. 2010 Dec 9;363(24):2320-31. doi: 10.1056/NEJMoa1005359."}, {'pmid': '35705944', 'type': 'DERIVED', 'citation': 'Sutter MB, Watson H, Yonke N, Weitzen S, Leeman L. Morphine versus methadone for neonatal opioid withdrawal syndrome: a randomized controlled pilot study. BMC Pediatr. 2022 Jun 15;22(1):345. doi: 10.1186/s12887-022-03401-3.'}, {'pmid': '34231914', 'type': 'DERIVED', 'citation': 'Zankl A, Martin J, Davey JG, Osborn DA. Opioid treatment for opioid withdrawal in newborn infants. Cochrane Database Syst Rev. 2021 Jul 7;7(7):CD002059. doi: 10.1002/14651858.CD002059.pub4.'}]}, 'descriptionModule': {'briefSummary': 'This study investigates the use of methadone versus morphine wean for the treatment of neonatal abstinence syndrome for infants exposed to opioids in utero. Half of infants who require pharmacotherapy for NAS will receive a methadone wean, and half will receive a morphine wean. Length of hospital stay, length of treatment and parent satisfaction will be studied.', 'detailedDescription': 'Neonates exposed to opiates in utero can develop a constellation of withdrawal symptoms known as neonatal abstinence syndrome (NAS). Infants with NAS are at risk for multiple medical complications including failure to thrive and seizures, they often require prolonged hospital stays and account for significant health care costs. At University of New Mexico, infants exposed to methadone or heroin in utero who develop NAS requiring pharmacologic treatment undergo a treatment wean with methadone, whereas infants exposed to buprenorphine undergo a wean with morphine. However, morphine is used frequently to treat neonatal abstinence syndrome among methadone-exposed infants throughout the US, and optimal pharmacologic treatment for NAS remains unknown. Anecdotal evidence at the investigators institution suggests that infants treated with morphine have shorter hospital stays compared to infants treated with methadone. Investigators propose a pilot randomized controlled trial to evaluate morphine vs methadone treatment of infants with in-utero methadone or heroin exposure. Specifically, length of treatment, need for additional medication to treat withdrawal, and length of hospital stay will be compared.\n\nWhen women are admitted to Labor and Delivery and/or up to 12 hours postpartum, research staff will approach patients about study enrollment. Participants will be approached for study enrollment if medication list on admission includes methadone, if participants self-report methadone use prenatally, and/ or if urine drug screen is positive for methadone or opiates on admission. If women choose to enroll in the study, and their infants require treatment for NAS, their infants will be randomized and assigned a study number for treatment using the methadone or morphine protocols at the time treatment is required.\n\nAll infants will be monitored for signs of withdrawal using the standard UNM NAS scoring protocol. Standard of care at UNM is to treat infants exposed to opioids in-utero with methadone if they require pharmacologic therapy for NAS, therefore treatment will not be withheld if they choose not to enroll in the study. Standard of care is also to obtain a urine drug screen on all infants with reported exposure to opiates in pregnancy. Enrolled patients will thus undergo routine urine drug screening. The only difference from standard care with regards to the study protocol is the treatment of half of the methadone or heroin exposed infants with morphine. The morphine protocol is proven for safety and efficacy currently in buprenorphine exposed infants. Once randomized, infants will continue on the protocol until discharge. At discharge, parents will complete a patient satisfaction survey.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Hours', 'minimumAge': '0 Hours', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Born at University of New Mexico Hospital\n* Greater than 34 weeks gestation\n* Primary in-utero drug exposure was opioids other than buprenorphine\n* Maternal or infant urine drug screen positive for methadone and/or opioids on admission\n\nExclusion criteria:\n\n* Born prior to 34 weeks\n* Neonatal intensive care unit admission\n* Serious medical comorbidities\n* Primary substance exposure in-utero was buprenorphine, or was not opioids'}, 'identificationModule': {'nctId': 'NCT02851303', 'briefTitle': 'Morphine Versus Methadone for Opiate Exposed Infants With Neonatal Abstinence Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University of New Mexico'}, 'officialTitle': 'Morphine Versus Methadone for Opiate Exposed Infants With Neonatal Abstinence Syndrome', 'orgStudyIdInfo': {'id': '16-176'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Morphine', 'description': 'Dose given q 3 - 4 hrs with feeds; do not exceed 4 hrs between doses Morphine (0.04mg/0.1ml)\n\nScore Dose For Initiation 0-8 0 None 9-12 0.04 mg/dose 13-16 0.08 mg/dose 17-20 0.12 mg/dose 21-24 0.16 mg/dose 25 or above 0.20mg/dose\n\nMorphine Maintenance/Escalation\n\n* Maintain dose if score 0-8\n* Increase dose by 0.02 if score is 9-12 (rescore before dosing) • Increase dose by 0.04 if score 13-16\n* Increase score by 0.06 if score 17-20\n\nWeaning Instructions:\n\n* Maintain on dose 48 hrs before starting weaning\n* Wean 0.02 mg morphine every day for a score is 0-8 • Defer wean for score 9-12\n\nRe-escalation\n\n* If neonate scores 9-12 re-score as described for initiation,\n* If second score is in 9-12 increase morphine 0.01 mg q3-4 hrs • If 2 consecutive scores 13-16, increase 0.02 mg q3-4 hrs\n* If 2 consecutive scores in 17-20, increase 0.04 mg q3-4 hrs etc', 'interventionNames': ['Drug: Morphine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Methadone', 'description': 'Step 1: 0.7 mgs/Kg/24 hrs. divided by into six doses (q 4 hrs) is starting dose Step 2: Decrease dose by half, which is 50% of starting dose, EVERY 4 hours. Step 3: Same dose which is 50% of starting dose EVERY 6 hours. Step 4: Same dose which is 50% of starting dose EVERY 8 hours. Step 5: Same dose which is 50% of starting dose EVERY 12 hours. Step 6: Decrease dose by half, which is 25% of starting dose EVERY 12 hours. Step 7: Same dose which is 25% of starting dose q 24 hours', 'interventionNames': ['Drug: Methadone']}], 'interventions': [{'name': 'Morphine', 'type': 'DRUG', 'description': 'Morphine wean protocol as described in arm description', 'armGroupLabels': ['Morphine']}, {'name': 'Methadone', 'type': 'DRUG', 'description': 'Methadone wean protocol as described in arm description', 'armGroupLabels': ['Methadone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '87106', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico Health Sciences Center', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}], 'overallOfficials': [{'name': 'Mary Beth Sutter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Attending Physician, Assistant Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of New Mexico', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending Physician, Assistant Professor', 'investigatorFullName': 'Mary Beth Sutter', 'investigatorAffiliation': 'University of New Mexico'}}}}