Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-25 @ 9:09 PM
Study NCT ID:
NCT01136356
Status:
COMPLETED
Last Update Posted:
2017-03-03
First Post:
2010-06-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Within Subject Comparison of Opioid Withdrawal in Opioid Dependent Individuals
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'D002047', 'term': 'Buprenorphine'}, {'id': 'D009020', 'term': 'Morphine'}], 'ancestors': [{'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': 'D009022', 'term': 'Morphine Derivatives'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'estrain1@jhmi.edu', 'phone': '410-550-1191', 'title': 'Eric C. Strain, MD', 'organization': 'Johns Hopkins University, School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'All Participants', 'description': "The adverse events were not specified per drug intervention, therefore, the adverse events per interventions is unknown. The data below references the adverse events recorded by licensed nursing personnel during the participants' 59-day protocol in a residential research unit. All participants (N=7) were randomized to receive either buprenorphine (32 mg/day i.m.) or morphine (120 mg/day i.m.) administered in four divided doses each day for 9 days (8 mg of buprenorphine four times per day, or 30 mg of morphine four times per day). Participants then underwent an 18-day period of spontaneous opioid withdrawal, during which four double blind i.m. placebo injections were administered daily. After the period of spontaneous withdrawal, participants received the second opioid administration and spontaneous withdrawal period using the same time course described above.", 'otherNumAtRisk': 12, 'otherNumAffected': 4, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 13, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Indigestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 14, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Lacrimation Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 11, 'numAffected': 2}], 'organSystem': 'Eye disorders'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 10, 'numAffected': 2}], 'organSystem': 'General disorders'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 12, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 34, 'numAffected': 4}], 'organSystem': 'General disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Peak Opioid Withdrawal Assessed by the Clinical Opiate Withdrawal Scale (COWS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Morphine'}, {'id': 'OG001', 'title': 'Buprenorphine'}], 'classes': [{'categories': [{'measurements': [{'value': '12.6', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '48'}, {'value': '1.3', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '48'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Average mean peak opioid withdrawal thirty minutes before and after injection assessed up to 59 days', 'description': 'Clinical Opiate Withdrawal Scale (COWS) is an observer-rated tool for quantifying opioid withdrawal. The scale ranges from 0 to 48: Scores 5 to 12 are mild, 13 to 24 are moderate, 25 to 36 are moderately severe, and over 36 are severe withdrawal. The scores on this repeated measure were analyzed by a two-factor ANOVA for mean peak daily COWS ratings.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Daily Peak Pain Ratings Assessed by the Visual Analog Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Morphine'}, {'id': 'OG001', 'title': 'Buprenorphine'}], 'classes': [{'title': 'Day 0 Withdrawal', 'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '100'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '100'}]}]}, {'title': 'Day 1 Withdrawal', 'categories': [{'measurements': [{'value': '29.3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '100'}, {'value': '6.3', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '100'}]}]}, {'title': 'Day 2 Withdrawal', 'categories': [{'measurements': [{'value': '51.6', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '100'}, {'value': '13.3', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '100'}]}]}, {'title': 'Day 3 Withdrawal', 'categories': [{'measurements': [{'value': '33.1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '100'}, {'value': '9.4', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '100'}]}]}, {'title': 'Day 4 Withdrawal', 'categories': [{'measurements': [{'value': '29.9', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '100'}, {'value': '8.6', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '100'}]}]}, {'title': 'Day 5 Withdrawal', 'categories': [{'measurements': [{'value': '20.1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '100'}, {'value': '11.4', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '100'}]}]}, {'title': 'Day 6 Withdrawal', 'categories': [{'measurements': [{'value': '20.3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '100'}, {'value': '8.6', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '100'}]}]}, {'title': 'Day 7 Withdrawal', 'categories': [{'measurements': [{'value': '11.9', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '100'}, {'value': '8.6', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '100'}]}]}, {'title': 'Day 8 Withdrawal', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '100'}, {'value': '13.6', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '100'}]}]}, {'title': 'Day 9 Withdrawal', 'categories': [{'measurements': [{'value': '17.0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '100'}, {'value': '8.6', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '100'}]}]}, {'title': 'Day 10 Withdrawal', 'categories': [{'measurements': [{'value': '13.4', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '100'}, {'value': '6.3', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '100'}]}]}, {'title': 'Day 11 Withdrawal', 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '100'}, {'value': '8.3', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '100'}]}]}, {'title': 'Day 12 Withdrawal', 'categories': [{'measurements': [{'value': '11.7', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '100'}, {'value': '9.1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '100'}]}]}, {'title': 'Day 13 Withdrawal', 'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '100'}, {'value': '12.7', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '100'}]}]}, {'title': 'Day 14 Withdrawal', 'categories': [{'measurements': [{'value': '6.9', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '100'}, {'value': '7.9', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '100'}]}]}, {'title': 'Day 15 Withdrawal', 'categories': [{'measurements': [{'value': '15.6', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '100'}, {'value': '12.9', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '100'}]}]}, {'title': 'Day 16 Withdrawal', 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '100'}, {'value': '11.6', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '100'}]}]}, {'title': 'Day 17 Withdrawal', 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '100'}, {'value': '6.7', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '100'}]}]}, {'title': 'Day 18 Withdrawal', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '100'}, {'value': '9.4', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '100'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Average mean daily peak pain ratings assessed from day 0 to day 18 during the 18 day withdrawal period', 'description': 'Visual Analog Scale (VAS) measures subjective ratings on pain. The scale on this measurement ranges from 0 being "None" to 100 being "Extremely". The results below reflect the subjective measurements of pain taken from day 0 to day 18 of withdrawal from both morphine and buprenorphine.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Peak Sleep Assessed by Pittsburgh Sleep Quality Index (PSQI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Morphine'}, {'id': 'OG001', 'title': 'Buprenorphine'}], 'classes': [{'title': 'Week 2 Withdrawal', 'categories': [{'measurements': [{'value': '10.3', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '2', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 Withdrawal', 'categories': [{'measurements': [{'value': '11.3', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '6.9', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Average mean peak sleep assessed once a week for up to 8 weeks', 'description': 'Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality, total scores range from 0 (better) to 21(worse). The data that has been reported reflects the peak scores on the PSQI during the withdrawal period from both morphine and buprenorphine.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Morphine First, Then Buprenorphine', 'description': 'Participants randomized to receive morphine (120 mg/day i.m.) administered in four divide doses for 9 days. Then underwent an 18-day period of spontaneous withdrawal, during which 4 double blind i.m. placebo injections were administered daily. Then administered using buprenorphine (32 mg/day i.m.) with the same time course'}, {'id': 'FG001', 'title': 'Buprenorphine First, Then Morphine', 'description': 'Participants randomized to receive buprenorphine (32 mg/day i.m.) administered in four divide doses for 9 days. Then underwent an 18-day period of spontaneous withdrawal, during which 4 double blind i.m. placebo injections were administered daily. Then administered using morphine (120 mg/day i.m.) with the same time course'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'First 18-day Withdrawal', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second 18-day Withdrawal', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The study site was an in-patient research-based clinic affiliated with the Johns Hopkins University School of Medicine.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Within Subjects Design', 'description': 'Participants received both study drugs (buprenorphine and morphine) in a randomized sequence.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-11', 'studyFirstSubmitDate': '2010-06-02', 'resultsFirstSubmitDate': '2016-04-14', 'studyFirstSubmitQcDate': '2010-06-02', 'lastUpdatePostDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-01-11', 'studyFirstPostDateStruct': {'date': '2010-06-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Peak Opioid Withdrawal Assessed by the Clinical Opiate Withdrawal Scale (COWS)', 'timeFrame': 'Average mean peak opioid withdrawal thirty minutes before and after injection assessed up to 59 days', 'description': 'Clinical Opiate Withdrawal Scale (COWS) is an observer-rated tool for quantifying opioid withdrawal. The scale ranges from 0 to 48: Scores 5 to 12 are mild, 13 to 24 are moderate, 25 to 36 are moderately severe, and over 36 are severe withdrawal. The scores on this repeated measure were analyzed by a two-factor ANOVA for mean peak daily COWS ratings.'}], 'secondaryOutcomes': [{'measure': 'Mean Daily Peak Pain Ratings Assessed by the Visual Analog Scale (VAS)', 'timeFrame': 'Average mean daily peak pain ratings assessed from day 0 to day 18 during the 18 day withdrawal period', 'description': 'Visual Analog Scale (VAS) measures subjective ratings on pain. The scale on this measurement ranges from 0 being "None" to 100 being "Extremely". The results below reflect the subjective measurements of pain taken from day 0 to day 18 of withdrawal from both morphine and buprenorphine.'}, {'measure': 'Mean Peak Sleep Assessed by Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': 'Average mean peak sleep assessed once a week for up to 8 weeks', 'description': 'Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality, total scores range from 0 (better) to 21(worse). The data that has been reported reflects the peak scores on the PSQI during the withdrawal period from both morphine and buprenorphine.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['opioid pharmacology', 'buprenorphine', 'morphine', 'withdrawal', 'human research'], 'conditions': ['Opioid Abuse', 'Opioid Dependence']}, 'referencesModule': {'references': [{'pmid': '24227768', 'type': 'RESULT', 'citation': 'Tompkins DA, Smith MT, Mintzer MZ, Campbell CM, Strain EC. A double blind, within subject comparison of spontaneous opioid withdrawal from buprenorphine versus morphine. J Pharmacol Exp Ther. 2014 Feb;348(2):217-26. doi: 10.1124/jpet.113.209478. Epub 2013 Nov 13.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/24227768', 'label': 'A double Blind, within Subjects Comparison of Spontaneous Opioid Withdrawal from Buprenorphine versus Morphine'}]}, 'descriptionModule': {'briefSummary': 'Buprenorphine is an approved medication for the treatment of opioid dependence. It is typically administered once daily as a sublingual tablet combined with naloxone (i.e., Suboxone). Evidence suggests buprenorphine produces relatively low levels of physical dependence. In addition, some research suggests there is relatively little withdrawal following cessation of chronically administered buprenorphine. This study will examine the spontaneous withdrawal associated with abrupt cessation of buprenorphine compared to morphine in opioid dependent individuals. This study will assess the characteristics and time course of withdrawal using subject-rated and observer-rated measures of opioid withdrawal. Physiologic measures and psychomotor performance will be collected during chronic opioid administration and during placebo administration (i.e., during spontaneous withdrawal). Particular attention will be paid to the differences (if any) in sleep disturbances and withdrawal associated hyperalgesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be adults ranging in age from 21-55 years old.\n* Be dependent on opioids.\n* Be willing to accept or desiring of opioid detoxification.\n* He healthy as determined by medical screen, history, and vitals.\n* Be without significant psychiatric illness besides drug dependence.\n* Be without chronic pain.\n* Fluent in English (speaking, writing, and reading).\n* Be willing and able to participate.\n\nExclusion Criteria:\n\n* Previous documented allergy to buprenorphine or morphine.\n* Are dependent on other drugs besides opioids and tobacco.\n* Have current history of significant use of alcohol or sedative/hypnotics.\n* Have evidence of significant medical (e.g., insulin dependent diabetes mellitus) or psychiatric (e.g., schizophrenia) illness.\n* Are pregnant (female volunteers will receive a pregnancy test before participation in the study and routinely during the study).\n* Have an abnormal or prolongation of the corrected QT interval (QTc) on a baseline electrocardiogram (ECG).\n* Are seeking treatment for their substance dependence.'}, 'identificationModule': {'nctId': 'NCT01136356', 'briefTitle': 'A Within Subject Comparison of Opioid Withdrawal in Opioid Dependent Individuals', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'A Within Subject Comparison of Opioid Withdrawal in Opioid Dependent Individuals', 'orgStudyIdInfo': {'id': 'NIDA-08045-9'}, 'secondaryIdInfos': [{'id': 'R01DA008045', 'link': 'https://reporter.nih.gov/quickSearch/R01DA008045', 'type': 'NIH'}, {'id': 'DPMC', 'type': 'OTHER', 'domain': 'NIDA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Morphine, then Buprenorphine', 'description': 'Healthy, out of treatment opioid-dependent residential volunteers (N=7) were randomized to receive morphine (120 mg/day i.m.) administered in four divided doses each day for 9 days (30 mg of morphine four times per day). Participants then underwent an 18-day period of spontaneous opioid withdrawal, during which four double blind i.m. placebo injections were administered daily. After the period of spontaneous withdrawal, participants received buprenorphine (32 mg/day i.m.) administered in four divided doses each day for 9 days (8 mg of buprenorphine four times per day) followed by a second 18-day period of spontaneous withdrawal identical to the withdrawal period described above.', 'interventionNames': ['Drug: buprenorphine', 'Drug: morphine']}, {'type': 'EXPERIMENTAL', 'label': 'Buprenorphine, then Morphine', 'description': 'Healthy, out of treatment opioid-dependent residential volunteers (N=7) were randomized to receive buprenorphine (32 mg/day i.m.) administered in four divided doses each day for 9 days (8 mg of buprenorphine four times per day). Participants then underwent an 18-day period of spontaneous withdrawal, during which four double blind i.m. placebo injections were administered daily. After the period of spontaneous withdrawal, participants received morphine (120 mg/day i.m.) administered in four divided doses each day for 9 days (30 mg of morphine four times per day) followed by a second 18-day period of spontaneous withdrawal identical to the withdrawal period described above.', 'interventionNames': ['Drug: buprenorphine', 'Drug: morphine']}], 'interventions': [{'name': 'buprenorphine', 'type': 'DRUG', 'description': 'parenteral buprenorphine may be administered at multiple times each day', 'armGroupLabels': ['Buprenorphine, then Morphine', 'Morphine, then Buprenorphine']}, {'name': 'morphine', 'type': 'DRUG', 'description': 'parenteral morphine may be administered multiple times each day', 'armGroupLabels': ['Buprenorphine, then Morphine', 'Morphine, then Buprenorphine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21224', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Behavioral Pharmacology Research Unit', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Eric Strain, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}