Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2026-01-05 @ 1:13 AM
Study NCT ID:
NCT01595867
Status:
COMPLETED
Last Update Posted:
2012-06-08
First Post:
2012-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Abuse Potential Assessment of Intranasally Administered EMBEDA Compared To Morphine Sulfate Controlled Release And Placebo
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D009293', 'term': 'Opioid-Related Disorders'}, {'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D000084783', 'term': 'Recreational Drug Use'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009271', 'term': 'Naltrexone'}], 'ancestors': [{'id': 'D009270', 'term': 'Naloxone'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-07', 'studyFirstSubmitDate': '2012-05-08', 'studyFirstSubmitQcDate': '2012-05-08', 'lastUpdatePostDateStruct': {'date': '2012-06-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Drug Liking Visual Analog Scale maximum peak effect (Emax)', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Drug Liking Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'High Visual Analog Scale maximum peak effect (Emax)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'High Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}], 'secondaryOutcomes': [{'measure': 'Drug Liking Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Drug Liking Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Drug Liking Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Drug Liking Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Drug Liking Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Drug Liking Visual Analog Scale Area time to maximum effect (TEmax)', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'High VVisual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'High Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'High Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'High Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'High Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'High Visual Analog Scale Area time to maximum effect (TEmax)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Any Drug Effects Visual Analog Scale maximum peak effect (Emax)', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Any Drug Effects Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Any Drug Effects Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Any Drug Effects Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Any Drug Effects Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Any Drug Effects Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Any Drug Effects Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Any Drug Effects Visual Analog Scale Area time to maximum effect (TEmax)', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Good Drug Effects Visual Analog Scale maximum peak effect (Emax)', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Good Drug Effects Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Good Drug Effects Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Good Drug Effects Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Good Drug Effects Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Good Drug Effects Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Good Drug Effects Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Good Drug Effects Visual Analog Scale Area time to maximum effect (TEmax)', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Bad Drug Effects Visual Analog Scale maximum peak effect (Emax)', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Bad Drug Effects Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Bad Drug Effects Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Bad Drug Effects Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Bad Drug Effects Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Bad Drug Effects Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Bad Drug Effects Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Bad Drug Effects Visual Analog Scale Area time to maximum effect (TEmax)', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Feel Sick Visual Analog Scale maximum peak effect (Emax)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Feel Sick Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Feel Sick Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Feel Sick Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Feel Sick Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Feel Sick Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Feel Sick Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Feel Sick Visual Analog Scale Area time to maximum effect (TEmax)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Nausea Visual Analog Scale maximum peak effect (Emax)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Nausea Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Nausea Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Nausea Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Nausea Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Nausea Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Nausea Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Nausea Visual Analog Scale Area time to maximum effect (TEmax)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Sleepy Visual Analog Scale maximum peak effect (Emax)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Sleepy Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Sleepy Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Sleepy Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Sleepy Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Sleepy Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Sleepy Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Sleepy Visual Analog Scale Area time to maximum effect (TEmax)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Dizzy Visual Analog Scale maximum peak effect (Emax)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Dizzy Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Dizzy Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Dizzy Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Dizzy Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Dizzy Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Dizzy Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Dizzy Visual Analog Scale Area time to maximum effect (TEmax)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Pupil Diameter minimum peak effect (Emin)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Pupil Diameter time to minimum peak effect (TEmin)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Pupil Diameter Area under the effect curve to 1 hour (AUE0-1h)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Pupil Diameter Area under the effect curve to 2 hours (AUE0-2h)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Pupil Diameter Area under the effect curve to 4 hours (AUE0-4h)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Pupil Diameter Area under the effect curve to 8 hours (AUE0-8h)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Pupil Diameter Area under the effect curve to 12 hours (AUE0-12h)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Pupil Diameter Area under the effect curve to 24 hours (AUE0-24h)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose'}, {'measure': 'Take Drug Again Visual Analog Scale maximum peak effect (Emax)', 'timeFrame': '12 and 24 hours post dose'}, {'measure': 'Take Drug Again Visual Analog Scale mean (Emean)', 'timeFrame': '12 and 24 hours post dose'}, {'measure': 'Overall Drug Liking Visual Analog Scale maximum peak effect (Emax)', 'timeFrame': '12 and 24 hours post dose'}, {'measure': 'Overall Drug Liking Visual Analog Scale mean (Emean)', 'timeFrame': '12 and 24 hours post dose'}, {'measure': 'Subject Rating Scale - Need to Blow Nose maximum peak effect (Emax)', 'timeFrame': 'pre dose and 0.5, 1, 1.5, and 2 hours post dose'}, {'measure': 'Subject Rating Scale - Need to Blow Nose Area under the effect curve to 1 hour (AUE0-1h)', 'timeFrame': 'pre dose and 0.5, 1, 1.5, and 2 hours post dose'}, {'measure': 'Subject Rating Scale - Need to Blow Nose Area under the effect curve to 2 hours (AUE0-2h)', 'timeFrame': 'pre dose and 0.5, 1, 1.5, and 2 hours post dose'}, {'measure': 'Subject Rating Scale - Runny Nose/Nasal Discharge maximum peak effect (Emax)', 'timeFrame': 'pre dose and 0.5, 1, 1.5, and 2 hours post dose'}, {'measure': 'Subject Rating Scale - Runny Nose/Nasal Discharge Area under the effect curve to 1 hour (AUE0-1h)', 'timeFrame': 'pre dose and 0.5, 1, 1.5, and 2 hours post dose'}, {'measure': 'Subject Rating Scale - Runny Nose/Nasal Discharge Area under the effect curve to 2 hours (AUE0-2h)', 'timeFrame': 'pre dose and 0.5, 1, 1.5, and 2 hours post dose'}, {'measure': 'Subject Rating Scale - Burning maximum peak effect (Emax)', 'timeFrame': 'pre dose and 0.5, 1, 1.5, and 2 hours post dose'}, {'measure': 'Subject Rating Scale - Burning Area under the effect curve to 1 hour (AUE0-1h)', 'timeFrame': 'pre dose and 0.5, 1, 1.5, and 2 hours post dose'}, {'measure': 'Subject Rating Scale - Burning Area under the effect curve to 2 hours (AUE0-2h)', 'timeFrame': 'pre dose and 0.5, 1, 1.5, and 2 hours post dose'}, {'measure': 'Subject Rating Scale - Facial Pain/Pressure maximum peak effect (Emax)', 'timeFrame': 'pre dose and 0.5, 1, 1.5, and 2 hours post dose'}, {'measure': 'Subject Rating Scale - Facial Pain/Pressure Area under the effect curve to 1 hour (AUE0-1h)', 'timeFrame': 'pre dose and 0.5, 1, 1.5, and 2 hours post dose'}, {'measure': 'Subject Rating Scale - Facial Pain/Pressure Area under the effect curve to 2 hours (AUE0-2h)', 'timeFrame': 'pre dose and 0.5, 1, 1.5, and 2 hours post dose'}, {'measure': 'Subject Rating Scale - Nasal Congestion maximum peak effect (Emax)', 'timeFrame': 'pre dose and 0.5, 1, 1.5, and 2 hours post dose'}, {'measure': 'Subject Rating Scale - Nasal Congestion Area under the effect curve to 1 hour (AUE0-1h)', 'timeFrame': 'pre dose and 0.5, 1, 1.5, and 2 hours post dose'}, {'measure': 'Subject Rating Scale - Nasal Congestion Area under the effect curve to 2 hours (AUE0-2h)', 'timeFrame': 'pre dose and 0.5, 1, 1.5, and 2 hours post dose'}, {'measure': 'Plasma morphine - Maximum observed plasma concentration (Cmax)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose'}, {'measure': 'Plasma morphine - Time to maximum observed plasma concentration (Tmax)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose'}, {'measure': 'Plasma morphine - Area under the plasma concentration time curve from time zero to 1 hour (AUC0-1h)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose'}, {'measure': 'Plasma morphine - Area under the plasma concentration time curve from time zero to 2 hours (AUC0-2h)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose'}, {'measure': 'Plasma morphine - Area under the plasma concentration time curve from time zero to 4 hours (AUC0-4h)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose'}, {'measure': 'Plasma 6-ß-naltrexol - Maximum observed plasma concentration (Cmax)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose'}, {'measure': 'Plasma 6-ß-naltrexol - Area under the plasma concentration time curve from time zero to 1 hour (AUC0-1h)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose'}, {'measure': 'Plasma 6-ß-naltrexol - Area under the plasma concentration time curve from time zero to 12 hours (AUC0-12h)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose'}, {'measure': 'Plasma 6-ß-naltrexol - Area under the plasma concentration time curve from time zero to 24 hours (AUC0-24h)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose'}, {'measure': 'Plasma 6-ß-naltrexol - Area under the plasma concentration time curve from time zero to 4 hours (AUC0-4h)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose'}, {'measure': 'Plasma 6-ß-naltrexol - Area under the plasma concentration time curve from time zero to 8 hours (AUC0-8h)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose'}, {'measure': 'Plasma 6-ß-naltrexol - Time to maximum observed plasma concentration (Tmax', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose'}, {'measure': 'Plasma 6-ß-naltrexol- Area under the plasma concentration time curve from time zero to 2 hours (AUC0-2h)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose'}, {'measure': 'Plasma 6-ß-naltrexol- Area under the plasma concentration time curve from time zero to infinity (AUC0-8), as applicable', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose'}, {'measure': 'Plasma morphine - Area under the plasma concentration time curve from time zero to 12 hours (AUC0-12h)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose'}, {'measure': 'Plasma morphine - Area under the plasma concentration time curve from time zero to 24 hours (AUC0-24h)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose'}, {'measure': 'Plasma morphine - Area under the plasma concentration time curve from time zero to 8 hours (AUC0-8h)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose'}, {'measure': 'Plasma morphine - Area under the plasma concentration time curve from time zero to infinity (AUC0-8), as applicable', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose'}, {'measure': 'Plasma naltrexone - Area under the plasma concentration time curve from time zero to 1 hour (AUC0-1h)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose'}, {'measure': 'Plasma naltrexone - Area under the plasma concentration time curve from time zero to 12 hours (AUC0-12h)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose'}, {'measure': 'Plasma naltrexone - Area under the plasma concentration time curve from time zero to 24 hours (AUC0-24h)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose'}, {'measure': 'Plasma naltrexone - Area under the plasma concentration time curve from time zero to 4 hours (AUC0-4h)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose'}, {'measure': 'Plasma naltrexone - Area under the plasma concentration time curve from time zero to 8 hours (AUC0-8h)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose'}, {'measure': 'Plasma naltrexone - Area under the plasma concentration time curve from time zero to infinity (AUC0-8), as applicable', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose'}, {'measure': 'Plasma naltrexone - Maximum observed plasma concentration (Cmax)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose'}, {'measure': 'Plasma naltrexone - Time to maximum observed plasma concentration (Tmax)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose'}, {'measure': 'Plasma naltrexone- Area under the plasma concentration time curve from time zero to 2 hours (AUC0-2h)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['abuse liability', 'abuse potential', 'morphine', 'intranasal administration', 'snorting', 'opioid abuse', 'pharmacodynamic', 'recreational drug use'], 'conditions': ['Narcotic Abuse', 'Opioid-related Disorders', 'Analgesia', 'Chronic Pain']}, 'referencesModule': {'references': [{'pmid': '23936895', 'type': 'DERIVED', 'citation': 'Setnik B, Goli V, Levy-Cooperman N, Mills C, Shram M, Smith I. Assessing the subjective and physiological effects of intranasally administered crushed extended-release morphine formulations with and without a sequestered naltrexone core in recreational opioid users. Pain Res Manag. 2013 Jul-Aug;18(4):e55-62. doi: 10.1155/2013/952082.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=ALO-01-10-4004&StudyName=Abuse%20Potential%20Assessment%20of%20Intranasally%20Administered%20EMBEDA%20Compared%20To%20Morphine%20Sulfate%20Controlled%20Release%20And%20Placebo%20', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This was a single-dose, randomized, double-blind, placebo-controlled, 3 way crossover study designed to evaluate the relative abuse potential of crushed EMBEDA® compared to morphine sulfate CR tablets and placebo in healthy male and female, non-dependent, recreational opioid users. An appropriate dose of morphine sulfate CR (i.e., 30 mg, 60 or 90 mg) was to be selected during Part A of the study (Dose Selection Phase). Each subject participated in the study for up to (approximately) 16 weeks and was confined in the clinic for a total of up to 12 nights.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male or female subjects 18 to 55 years of age, inclusive.\n* Subject is a recreational opioid user who is NOT dependent on opioids based on Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision (DSM-IV-TR) criteria and the Naloxone Challenge. A recreational opioid user is defined as use of opioids for non-therapeutic purposes (i.e., for psychoactive effects) on at least 10 occasions within the last year and at least once in the 12 weeks before the Screening Visit (Visit 1).\n* Subjects must have experience with intranasal drug administration, defined as intranasal use on at least 3 occasions within the last year prior to the Screening Visit.\n\nExclusion Criteria:\n\n* Diagnosis of substance and/or alcohol dependence (excluding caffeine and nicotine), as assessed by the Investigator using the DSM IV-TR criteria.\n* Has participated in, is currently participating in, or is seeking treatment for substance- and or alcohol-related disorders (excluding nicotine and caffeine).\n* Has any condition in which an opioid is contraindicated; e.g., significant respiratory depression, acute or severe bronchial asthma or hypercarbia, or is suspected of having paralytic ileus.\n* Allergy or history of hypersensitivity to morphine sulfate, other opioids, naltrexone hydrochloride, naloxone, and/or lactose.\n* History or current clinically significant neurological, cardiovascular, renal, hepatic, endocrine, gastrointestinal, hematologic, or metabolic disease as evaluated by the Investigator.\n* History or current pulmonary disease including asthma, chronic obstructive pulmonary disease, exercise-induced asthma, bronchitis, and obstructive sleep apnea.'}, 'identificationModule': {'nctId': 'NCT01595867', 'briefTitle': 'Abuse Potential Assessment of Intranasally Administered EMBEDA Compared To Morphine Sulfate Controlled Release And Placebo', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, 3 Way Crossover Study Evaluating The Relative Abuse Potential Of Crushed Embeda Compared To Morphine Sulfate Controlled Release Tablets (Crushed) And Placebo In Non-Dependent, Recreational Opioid Users Following Intranasal Administration', 'orgStudyIdInfo': {'id': 'ALO-01-10-4004'}, 'secondaryIdInfos': [{'id': 'B4541005'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Treatment A', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment B', 'description': 'EMBEDA 30 mg crushed', 'interventionNames': ['Drug: EMBEDA - morphine sulfate/ naltrexone hydrochloride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment C', 'description': 'Morphine Sulfate Controlled Release 30 mg crushed', 'interventionNames': ['Drug: morphine sulfate CR crushed.']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Lactose (100 mg) placebo tablets crushed; single dose', 'armGroupLabels': ['Treatment A']}, {'name': 'EMBEDA - morphine sulfate/ naltrexone hydrochloride', 'type': 'DRUG', 'description': 'EMBEDA (morphine sulfate/naltrexone hydrochloride) 30 mg/ 1.2 mg extended release; capsule contents crushed; single dose', 'armGroupLabels': ['Treatment B']}, {'name': 'morphine sulfate CR crushed.', 'type': 'DRUG', 'description': 'Morphine sulfate controlled release 30 mg tablet crushed', 'armGroupLabels': ['Treatment C']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}