Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2026-02-20 @ 6:41 PM
Study NCT ID:
NCT02922959
Status:
COMPLETED
Last Update Posted:
2020-06-24
First Post:
2016-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Tailored, Peer-delivered Intervention to Reduce Recurring Opioid Overdoses
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D062787', 'term': 'Drug Overdose'}, {'id': 'D009293', 'term': 'Opioid-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D063487', 'term': 'Prescription Drug Misuse'}, {'id': 'D000076064', 'term': 'Drug Misuse'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009270', 'term': 'Naloxone'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'winhust@ucmail.uc.edu', 'phone': '5135858292', 'title': 'Theresa Winhusen', 'organization': 'University of Cincinnati Addiction Sciences Division'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 months. Adverse events were systematically assessed during each research visit.', 'description': 'Serious Adverse Events were defined as an event that results in any of the following outcomes: death, life threatening, requires hospitalization, initial or prolonged, results in disability, congenital anomaly, requires intervention to prevent permanent impairment or damage, or other significant medical event.\n\nOther (non-Serious) adverse events were defined as suicidal ideation or homicidal ideation.', 'eventGroups': [{'id': 'EG000', 'title': 'PTOEND', 'description': 'PTOEND: Personally-tailored opioid overdose prevention education and naloxone distribution.\n\nParticipants in this arm will be given a NARCAN (naloxone) nasal spray kit and personally-tailored information packet about opioid overdose and treatment.\n\nnaloxone nasal spray kit: Naloxone nasal spray (NARCAN) is a potentially life-saving medication that can stop or reverse the effects of an opioid overdose.\n\nPersonally-tailored opioid overdose prevention education (information packet): Personally-tailored information packet with three participant-specific reports and general written information about opioid overdose and treatment for opioid use disorder.', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'PTOEND+PI', 'description': 'PTOEND+PI: Personally-tailored opioid overdose prevention education and naloxone distribution, plus Peer Intervention.\n\nIn addition to a NARCAN (naloxone) nasal spray kit and personally-tailored information packet about opioid overdose and treatment, participants randomized to this arm will also receive the experimental Peer Intervention.\n\nPeer Intervention: The Peer Intervention is a 20-minute telephone call delivered by a Peer Interventionist, who is trained to answer questions about the content of the personally-tailored information packets.\n\nnaloxone nasal spray kit: Naloxone nasal spray (NARCAN) is a potentially life-saving medication that can stop or reverse the effects of an opioid overdose.\n\nPersonally-tailored opioid overdose prevention education (information packet): Personally-tailored information packet with three participant-specific reports and general written information about opioid overdose and treatment for opioid use disorder.', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 7}], 'seriousEvents': [{'term': 'Hospitalization for musculoskeletal problem / injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Suicide Attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Congenital Anomaly or Birth Defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization for nervous system disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization for renal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization related to pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization for infection/abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization for psychiatric problem', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization for respiratory condition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization for multiple causes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Medication-Assisted Treatment Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PTOEND', 'description': 'PTOEND: Personally-tailored opioid overdose prevention education and naloxone distribution.\n\nParticipants in this arm will be given a NARCAN (naloxone) nasal spray kit and personally-tailored information packet about opioid overdose and treatment.\n\nnaloxone nasal spray kit: Naloxone nasal spray (NARCAN) is a potentially life-saving medication that can stop or reverse the effects of an opioid overdose.\n\nPersonally-tailored opioid overdose prevention education (information packet): Personally-tailored information packet with three participant-specific reports and general written information about opioid overdose and treatment for opioid use disorder.'}, {'id': 'OG001', 'title': 'PTOEND+PI', 'description': 'PTOEND+PI: Personally-tailored opioid overdose prevention education and naloxone distribution, plus Peer Intervention.\n\nIn addition to a NARCAN (naloxone) nasal spray kit and personally-tailored information packet about opioid overdose and treatment, participants randomized to this arm will also receive the experimental Peer Intervention.\n\nPeer Intervention: The Peer Intervention is a 20-minute telephone call delivered by a Peer Interventionist, who is trained to answer questions about the content of the personally-tailored information packets.\n\nnaloxone nasal spray kit: Naloxone nasal spray (NARCAN) is a potentially life-saving medication that can stop or reverse the effects of an opioid overdose.\n\nPersonally-tailored opioid overdose prevention education (information packet): Personally-tailored information packet with three participant-specific reports and general written information about opioid overdose and treatment for opioid use disorder.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'whether or not participant enrolled in medication-assisted treatment within the follow-up period', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Opioid Overdose Experience', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PTOEND', 'description': 'PTOEND: Personally-tailored opioid overdose prevention education and naloxone distribution.\n\nParticipants in this arm will be given a NARCAN (naloxone) nasal spray kit and personally-tailored information packet about opioid overdose and treatment.\n\nnaloxone nasal spray kit: Naloxone nasal spray (NARCAN) is a potentially life-saving medication that can stop or reverse the effects of an opioid overdose.\n\nPersonally-tailored opioid overdose prevention education (information packet): Personally-tailored information packet with three participant-specific reports and general written information about opioid overdose and treatment for opioid use disorder.'}, {'id': 'OG001', 'title': 'PTOEND+PI', 'description': 'PTOEND+PI: Personally-tailored opioid overdose prevention education and naloxone distribution, plus Peer Intervention.\n\nIn addition to a NARCAN (naloxone) nasal spray kit and personally-tailored information packet about opioid overdose and treatment, participants randomized to this arm will also receive the experimental Peer Intervention.\n\nPeer Intervention: The Peer Intervention is a 20-minute telephone call delivered by a Peer Interventionist, who is trained to answer questions about the content of the personally-tailored information packets.\n\nnaloxone nasal spray kit: Naloxone nasal spray (NARCAN) is a potentially life-saving medication that can stop or reverse the effects of an opioid overdose.\n\nPersonally-tailored opioid overdose prevention education (information packet): Personally-tailored information packet with three participant-specific reports and general written information about opioid overdose and treatment for opioid use disorder.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'whether or not participant experienced an opioid overdose within the follow-up period period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Opioid Use (Timeline Follow-back)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PTOEND', 'description': 'PTOEND: Personally-tailored opioid overdose prevention education and naloxone distribution.\n\nParticipants in this arm will be given a NARCAN (naloxone) nasal spray kit and personally-tailored information packet about opioid overdose and treatment.\n\nnaloxone nasal spray kit: Naloxone nasal spray (NARCAN) is a potentially life-saving medication that can stop or reverse the effects of an opioid overdose.\n\nPersonally-tailored opioid overdose prevention education (information packet): Personally-tailored information packet with three participant-specific reports and general written information about opioid overdose and treatment for opioid use disorder.'}, {'id': 'OG001', 'title': 'PTOEND+PI', 'description': 'PTOEND+PI: Personally-tailored opioid overdose prevention education and naloxone distribution, plus Peer Intervention.\n\nIn addition to a NARCAN (naloxone) nasal spray kit and personally-tailored information packet about opioid overdose and treatment, participants randomized to this arm will also receive the experimental Peer Intervention.\n\nPeer Intervention: The Peer Intervention is a 20-minute telephone call delivered by a Peer Interventionist, who is trained to answer questions about the content of the personally-tailored information packets.\n\nnaloxone nasal spray kit: Naloxone nasal spray (NARCAN) is a potentially life-saving medication that can stop or reverse the effects of an opioid overdose.\n\nPersonally-tailored opioid overdose prevention education (information packet): Personally-tailored information packet with three participant-specific reports and general written information about opioid overdose and treatment for opioid use disorder.'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.2', 'spread': '12.7', 'groupId': 'OG000'}, {'value': '-8.7', 'spread': '13.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at 12-month visit', 'description': 'Difference in self-reported opioid use in the prior 28 days, from Baseline to 12-month visit, computed as: (12-month opioid use days - Baseline opioid use days); negative values indicate a reduction in self-reported opioid use days from Baseline to 12-month visit.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis could only be done on data provided by participants who attended the 12-month visit'}, {'type': 'SECONDARY', 'title': 'Change in Opioid Use (Urine Drug Screen)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PTOEND', 'description': 'PTOEND: Personally-tailored opioid overdose prevention education and naloxone distribution.\n\nParticipants in this arm will be given a NARCAN (naloxone) nasal spray kit and personally-tailored information packet about opioid overdose and treatment.\n\nnaloxone nasal spray kit: Naloxone nasal spray (NARCAN) is a potentially life-saving medication that can stop or reverse the effects of an opioid overdose.\n\nPersonally-tailored opioid overdose prevention education (information packet): Personally-tailored information packet with three participant-specific reports and general written information about opioid overdose and treatment for opioid use disorder.'}, {'id': 'OG001', 'title': 'PTOEND+PI', 'description': 'PTOEND+PI: Personally-tailored opioid overdose prevention education and naloxone distribution, plus Peer Intervention.\n\nIn addition to a NARCAN (naloxone) nasal spray kit and personally-tailored information packet about opioid overdose and treatment, participants randomized to this arm will also receive the experimental Peer Intervention.\n\nPeer Intervention: The Peer Intervention is a 20-minute telephone call delivered by a Peer Interventionist, who is trained to answer questions about the content of the personally-tailored information packets.\n\nnaloxone nasal spray kit: Naloxone nasal spray (NARCAN) is a potentially life-saving medication that can stop or reverse the effects of an opioid overdose.\n\nPersonally-tailored opioid overdose prevention education (information packet): Personally-tailored information packet with three participant-specific reports and general written information about opioid overdose and treatment for opioid use disorder.'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at 12-month visit', 'description': 'Number of participants who provided an opioid-negative urine sample, assessed by a rapid urine drug screen system, at the 12-month visit. Results that were positive, but specific to only buprenorphine or methadone, were counted as negative for participants with verified enrollment in medication-assisted treatment. Note that all participants were required to have an opioid-positive urine sample at Baseline, in order to be eligible for the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis could only be done on samples provided by participants who attended the 12-month visit'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PTOEND', 'description': 'PTOEND: Personally-tailored opioid overdose prevention education and naloxone distribution.\n\nParticipants in this arm will be given a NARCAN (naloxone) nasal spray kit and personally-tailored information packet about opioid overdose and treatment.\n\nnaloxone nasal spray kit: Naloxone nasal spray (NARCAN) is a potentially life-saving medication that can stop or reverse the effects of an opioid overdose.\n\nPersonally-tailored opioid overdose prevention education (information packet): Personally-tailored information packet with three participant-specific reports and general written information about opioid overdose and treatment for opioid use disorder.'}, {'id': 'FG001', 'title': 'PTOEND+PI', 'description': 'PTOEND+PI: Personally-tailored opioid overdose prevention education and naloxone distribution, plus Peer Intervention.\n\nIn addition to a NARCAN (naloxone) nasal spray kit and personally-tailored information packet about opioid overdose and treatment, participants randomized to this arm will also receive the experimental Peer Intervention.\n\nPeer Intervention: The Peer Intervention is a 20-minute telephone call delivered by a Peer Interventionist, who is trained to answer questions about the content of the personally-tailored information packets.\n\nnaloxone nasal spray kit: Naloxone nasal spray (NARCAN) is a potentially life-saving medication that can stop or reverse the effects of an opioid overdose.\n\nPersonally-tailored opioid overdose prevention education (information packet): Personally-tailored information packet with three participant-specific reports and general written information about opioid overdose and treatment for opioid use disorder.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': '3 Weeks', 'achievements': [{'comment': 'n=38 (95.0%)', 'groupId': 'FG000', 'numSubjects': '38'}, {'comment': 'n=36 (90.0%)', 'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': '3 Months', 'achievements': [{'comment': 'n=35 (87.5%)', 'groupId': 'FG000', 'numSubjects': '35'}, {'comment': 'n=31 (77.5%)', 'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': '6 Months', 'achievements': [{'comment': 'n=28 (70.0%)', 'groupId': 'FG000', 'numSubjects': '28'}, {'comment': 'n=30 (75.0%)', 'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': '12 Months', 'achievements': [{'comment': 'n=21 (52.5%)', 'groupId': 'FG000', 'numSubjects': '21'}, {'comment': 'n=23 (57.5%)', 'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '17'}]}]}], 'recruitmentDetails': 'Potential participants were recruited through various methods including advertisements, flyers, and word-of-mouth. Greater than 90% of participants were recruited from a syringe exchange program. All participants were given a thorough explanation of the study and signed an informed consent form.', 'preAssignmentDetails': '116 potential participants were consented and screened, and 80 were randomized to Personally-tailored opioid overdose education and naloxone distribution plus Peer Intervention (PTOEND+PI) (n=40) or PTOEND (n=40).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'PTOEND', 'description': 'PTOEND: Personally-tailored opioid overdose prevention education and naloxone distribution.\n\nParticipants in this arm will be given a NARCAN (naloxone) nasal spray kit and personally-tailored information packet about opioid overdose and treatment.\n\nnaloxone nasal spray kit: Naloxone nasal spray (NARCAN) is a potentially life-saving medication that can stop or reverse the effects of an opioid overdose.\n\nPersonally-tailored opioid overdose prevention education (information packet): Personally-tailored information packet with three participant-specific reports and general written information about opioid overdose and treatment for opioid use disorder.'}, {'id': 'BG001', 'title': 'PTOEND+PI', 'description': 'PTOEND+PI: Personally-tailored opioid overdose prevention education and naloxone distribution, plus Peer Intervention.\n\nIn addition to a NARCAN (naloxone) nasal spray kit and personally-tailored information packet about opioid overdose and treatment, participants randomized to this arm will also receive the experimental Peer Intervention.\n\nPeer Intervention: The Peer Intervention is a 20-minute telephone call delivered by a Peer Interventionist, who is trained to answer questions about the content of the personally-tailored information packets.\n\nnaloxone nasal spray kit: Naloxone nasal spray (NARCAN) is a potentially life-saving medication that can stop or reverse the effects of an opioid overdose.\n\nPersonally-tailored opioid overdose prevention education (information packet): Personally-tailored information packet with three participant-specific reports and general written information about opioid overdose and treatment for opioid use disorder.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.0', 'spread': '10.3', 'groupId': 'BG000'}, {'value': '40.3', 'spread': '12.5', 'groupId': 'BG001'}, {'value': '39.1', 'spread': '11.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-08-08', 'size': 393510, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-06-04T10:00', 'hasProtocol': False}, {'date': '2017-11-08', 'size': 1048679, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-06-04T10:11', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2019-07-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-04', 'studyFirstSubmitDate': '2016-09-30', 'resultsFirstSubmitDate': '2020-06-04', 'studyFirstSubmitQcDate': '2016-10-03', 'lastUpdatePostDateStruct': {'date': '2020-06-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-06-04', 'studyFirstPostDateStruct': {'date': '2016-10-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Medication-Assisted Treatment Enrollment', 'timeFrame': '12 months', 'description': 'whether or not participant enrolled in medication-assisted treatment within the follow-up period'}], 'secondaryOutcomes': [{'measure': 'Opioid Overdose Experience', 'timeFrame': '12 months', 'description': 'whether or not participant experienced an opioid overdose within the follow-up period period.'}, {'measure': 'Change in Opioid Use (Timeline Follow-back)', 'timeFrame': 'at 12-month visit', 'description': 'Difference in self-reported opioid use in the prior 28 days, from Baseline to 12-month visit, computed as: (12-month opioid use days - Baseline opioid use days); negative values indicate a reduction in self-reported opioid use days from Baseline to 12-month visit.'}, {'measure': 'Change in Opioid Use (Urine Drug Screen)', 'timeFrame': 'at 12-month visit', 'description': 'Number of participants who provided an opioid-negative urine sample, assessed by a rapid urine drug screen system, at the 12-month visit. Results that were positive, but specific to only buprenorphine or methadone, were counted as negative for participants with verified enrollment in medication-assisted treatment. Note that all participants were required to have an opioid-positive urine sample at Baseline, in order to be eligible for the study.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Opioid Substitution Treatment', 'Telephone intervention', 'secondary prevention', 'naloxone'], 'conditions': ['Drug Overdose', 'Opioid-Related Disorders', 'Drug Addiction', 'Drug Abuse', 'Substance Abuse']}, 'referencesModule': {'references': [{'pmid': '34236298', 'type': 'DERIVED', 'citation': 'Kropp F, Wilder C, Theobald J, Lewis D, Winhusen TJ. The feasibility and safety of training patients in opioid treatment to serve as peer recovery support service interventionists. Subst Abus. 2022;43(1):527-530. doi: 10.1080/08897077.2021.1949667. Epub 2021 Jul 8.'}]}, 'descriptionModule': {'briefSummary': 'This project will further develop and test the Tailored Telephone Intervention delivered by Peers to Prevent Recurring Opioid Overdoses (TTIP-PRO), a promising, low-cost, intervention to facilitate entry into medication assisted treatment (MAT) for individuals experiencing a non-fatal opioid overdoses (OOD). A prior small-scale pilot/feasibility study of TTIP-PRO (NCT02282306) found that the participating patients and the Peer Interventionists were satisfied with their participation, the intervention was acceptable, and the system for generating patient-tailored intervention information performed well. The overall goal of the present study is to conduct a pilot randomized controlled trial of TTIP-PRO versus a control group. It is hypothesized that patients in the TTIP-PRO group will have more favorable drug-abuse-related outcomes than patients in the control group.', 'detailedDescription': 'This pilot study is a randomized controlled intent-to-treat (ITT) clinical trial. Approximately eighty eligible participants will be randomized in a 1:1 ratio to the control condition (Information and NARCAN® (naloxone) Nasal Spray kit) or to the experimental condition (TTIP-PRO in addition to the elements provided in the control condition). All participants will complete a follow-up phone call approximately 3-weeks post-randomization, during which process measures will be completed, and in-person visits at approximately 3, 6-, and 12-months following enrollment.\n\nThis is a single site study; all data will be collected at the University of Cincinnati. Approximately 80 participants will be randomized into this pilot efficacy trial. The hypotheses to be tested include that participants assigned to the TTIP-PRO intervention will: have a higher rate of enrollment in MAT, have a lower rate of recurring opioid overdose, and have greater reduction in illicit opioid use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Report having been treated for an OOD within the past 6 months\n* Age 18 years or older;\n* Scores "high risk" for heroin and/or non-medical use of prescription opioids on the National Institute on Drug Abuse modified Alcohol, Smoking and Substance Involvement Screening Test (NIDA-modified ASSIST) (i.e., ≥ 27)\n* Be able to understand the study, and having understood, provide written informed consent in English\n* Access to a phone (for TTIP-PRO intervention and phone follow-up)\n* Be willing to have their intervention audio recorded and rated if randomized to TTIP-PRO\n* Have an opioid-positive baseline/screening urine drug screen.\n\nExclusion Criteria:\n\n* In the judgment of the investigator, would not be expected to complete the study protocol (e.g., due to relocation from the clinic area, probable incarceration, etc.)\n* Current engagement in addiction treatment\n* Residence more than 40 miles from the location of follow-up visits\n* Inability to provide sufficient contact information (must provide at least 2 reliable locators)\n* Prior participation in the current study.'}, 'identificationModule': {'nctId': 'NCT02922959', 'acronym': 'TTIP-PRO', 'briefTitle': 'A Tailored, Peer-delivered Intervention to Reduce Recurring Opioid Overdoses', 'organization': {'class': 'OTHER', 'fullName': 'University of Cincinnati'}, 'officialTitle': 'A Tailored, Peer-delivered Intervention to Reduce Recurring Opioid Overdoses', 'orgStudyIdInfo': {'id': '2016-6635'}, 'secondaryIdInfos': [{'id': 'R34DA040862', 'link': 'https://reporter.nih.gov/quickSearch/R34DA040862', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PTOEND', 'description': 'PTOEND: Personally-tailored opioid overdose prevention education and naloxone distribution.\n\nParticipants in this arm will be given a NARCAN (naloxone) nasal spray kit and personally-tailored information packet about opioid overdose and treatment.', 'interventionNames': ['Drug: naloxone nasal spray kit', 'Behavioral: Personally-tailored opioid overdose prevention education (information packet)']}, {'type': 'EXPERIMENTAL', 'label': 'PTOEND+PI', 'description': 'PTOEND+PI: Personally-tailored opioid overdose prevention education and naloxone distribution, plus Peer Intervention.\n\nIn addition to a NARCAN (naloxone) nasal spray kit and personally-tailored information packet about opioid overdose and treatment, participants randomized to this arm will also receive the experimental Peer Intervention.', 'interventionNames': ['Behavioral: Peer Intervention', 'Drug: naloxone nasal spray kit', 'Behavioral: Personally-tailored opioid overdose prevention education (information packet)']}], 'interventions': [{'name': 'Peer Intervention', 'type': 'BEHAVIORAL', 'description': 'The Peer Intervention is a 20-minute telephone call delivered by a Peer Interventionist, who is trained to answer questions about the content of the personally-tailored information packets. The primary goal of the call is for the participant and the Peer Interventionist to have an open exchange of information about medication-assisted treatment (MAT) for opioid use disorder.', 'armGroupLabels': ['PTOEND+PI']}, {'name': 'naloxone nasal spray kit', 'type': 'DRUG', 'otherNames': ['NARCAN'], 'description': 'Naloxone nasal spray (NARCAN) is a potentially life-saving medication that can stop or reverse the effects of an opioid overdose. This nasal spray is approved by the FDA for reversing OODs and has a favorable side-effects profile. A take-home kit will be provided to the patient participants, which may be useful in the event of a future opioid overdose.', 'armGroupLabels': ['PTOEND', 'PTOEND+PI']}, {'name': 'Personally-tailored opioid overdose prevention education (information packet)', 'type': 'BEHAVIORAL', 'description': 'Personally-tailored information packet with three participant-specific reports ("Personal Overdose Risk Factors Report"; "Medication Assisted Treatment (MAT) Report"; and the "Opioid Overdose Information Report"), and general written information about opioid overdose and treatment for opioid use disorder.', 'armGroupLabels': ['PTOEND', 'PTOEND+PI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati Addiction Sciences Division', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Theresa Winhusen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cincinnati'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Data will be shared in a timely manner, i.e., no later than the acceptance for publication of the main findings from the final dataset. The dataset will include information about illegal activities (e.g., illicit opioid use, etc.). Thus, in addition to only a de-identified database being shared, we will also require a data sharing agreement. The data sharing agreement will require commitment to: 1) not re-disclose the data; 2) secure the data; 3) use the data for research purposes only; 4) make no attempt to identify individual participants; 5) destroy the data once the planned research activities have been completed; 6) follow all relevant NIH policies.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cincinnati', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor; Associate Vice Chair and Division Director of Addiction Sciences', 'investigatorFullName': 'Theresa Winhusen, PhD', 'investigatorAffiliation': 'University of Cincinnati'}}}}