Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2025-12-28 @ 11:24 PM
Study NCT ID:
NCT04647903
Status:
COMPLETED
Last Update Posted:
2021-12-29
First Post:
2020-11-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Abuse Liability, Pharmacokinetics, Safety and Tolerability of an Abuse-Deterrent d-Amphetamine Sulfate Immediate Release Formulation (ADAIR)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}, {'id': 'D009290', 'term': 'Narcolepsy'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D006970', 'term': 'Disorders of Excessive Somnolence'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003913', 'term': 'Dextroamphetamine'}], 'ancestors': [{'id': 'D000661', 'term': 'Amphetamine'}, {'id': 'D000662', 'term': 'Amphetamines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-12-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-28', 'studyFirstSubmitDate': '2020-11-13', 'studyFirstSubmitQcDate': '2020-11-30', 'lastUpdatePostDateStruct': {'date': '2021-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Drug Liking Emax Visual Analog Scale (VAS)', 'timeFrame': 'Up to 24 hours post-dose', 'description': 'Peak effect for drug liking based on bipolar VAS from 0-100 scale'}], 'secondaryOutcomes': [{'measure': 'Take Drug Again Emax VAS', 'timeFrame': 'Up to 24 hours post dose', 'description': 'Peak effect for take drug again based on bipolar VAS from 0-100 scale'}, {'measure': 'Overall Drug Liking Emax VAS', 'timeFrame': 'Up to 24 hours post dose', 'description': 'Peak effect for overall drug liking based on bipolar VAS from 0-100 scale'}, {'measure': 'Plasma concentrations (PK parameters)', 'timeFrame': 'Up to 36 hours post dose', 'description': 'plasma concentrations of ADAIR and dextroamphetamine sulfate'}, {'measure': 'Safety (adverse events)', 'timeFrame': 'Day 1 to Day 18', 'description': 'Incidence of adverse events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ADHD', 'Narcolepsy']}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-blind, double-dummy, placebo- and active-controlled 4 period, 4 way crossover study to assess the intranasal abuse potential of manipulated ADAIR formulation in nondependent, recreational stimulant users. The study will consist of an outpatient Screening Visit, an in clinic Qualification Phase, an in-clinic Treatment Phase, and an outpatient Follow-Up visit.', 'detailedDescription': 'VAL-104 is a phase 1, randomized, double-blind, double-dummy, placebo- and active-controlled 4 period, 4 way crossover study to assess the intranasal abuse potential of manipulated ADAIR formulation in nondependent, recreational stimulant users. The study objectives include assessing the pharmacodynamics (PD), pharmacokinetics (PK), safety and tolerability of manipulated ADAIR 30mg when compared to crushed d-amphetamine sulfate and placebo. The primary PD endpoint is mean maximum drug liking (Emax) on a bipolar 100mm visual analog scale.\n\nA total of 64 subjects demonstrating a confirmed positive response to stimulants will enter the treatment phase. Safety will be assess via adverse events, vital signs, ECGs, clinical laboratory tests and Columbia Suicide Severity Rating Scale (C-SSRS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male or female volunteers, 18 to 55 years of age inclusive\n* Recreational drug abuse experience (\\>/= 10 times lifetime abuse of a CNS stimulant, \\>/= 1 abuse of CNS stimulant in the previous 3 months)\n* Prior intranasal recreational drug abuse experience\n* Body mass index (BMI) 18 to 33 kg/m2 inclusive\n\nExclusion Criteria:\n\n* History of any significant disease or disorder\n* History or current diagnosis of substance dependence (excluding caffeine and nicotine)\n* Any confirmed significant allergic reactions against any drug, or multiple allergies in the judgement of the investigator\n* Positive for hepatitis B, hepatitis C or HIV infection\n* Pregnant or lactating women\n* Participation in an investigational drug or device study within the last 30 days prior to Day 1 of the study\n* Confirmed positive drug screening\n* Positive alcohol breath test at screening / any Day -1\n* Heavy smoker (\\> 20 cigarettes, \\> 8 pipefuls or \\> 8 cigars per day)'}, 'identificationModule': {'nctId': 'NCT04647903', 'acronym': 'SEAL', 'briefTitle': 'Study to Evaluate the Abuse Liability, Pharmacokinetics, Safety and Tolerability of an Abuse-Deterrent d-Amphetamine Sulfate Immediate Release Formulation (ADAIR)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vallon Pharmaceuticals, Inc.'}, 'officialTitle': 'A Randomized, Double-Blind, Double-Dummy, Placebo-, Active-Controlled, 4 Period, 4 Way Crossover Study to Evaluate the Abuse Potential of Manipulated Abuse-Deterrent Dextroamphetamine Sulfate Immediate Release (ADAIR) Formulation Compared to Dextroamphetamine Sulfate Immediate Release When Administered Intranasally to Nondependent, Recreational Stimulant Users', 'orgStudyIdInfo': {'id': 'VAL-104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral Placebo + Intranasal manipulated ADAIR', 'description': 'Oral Placebo + Intranasal manipulated ADAIR 30 mg', 'interventionNames': ['Drug: ADAIR 10 mg IR tablets', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oral Placebo + Intranasal crushed dextroamphetamine sulfate', 'description': 'Oral Placebo + Intranasal crushed dextroamphetamine sulfate IR 30 mg', 'interventionNames': ['Drug: d-amphetamine sulfate', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Oral ADAIR + Intranasal Placebo', 'description': 'Oral ADAIR 30 mg + Intranasal Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Oral Placebo + Intranasal Placebo', 'description': 'Oral Placebo + Intranasal Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ADAIR 10 mg IR tablets', 'type': 'DRUG', 'otherNames': ['ADAIR'], 'description': 'manipulated ADAIR 3x10mg', 'armGroupLabels': ['Oral Placebo + Intranasal manipulated ADAIR']}, {'name': 'd-amphetamine sulfate', 'type': 'DRUG', 'otherNames': ['dextroamphetamine sulfate'], 'description': 'crushed d-amphetamine sulfate 3x10mg', 'armGroupLabels': ['Oral Placebo + Intranasal crushed dextroamphetamine sulfate']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'placebo for oral and intranasal administration', 'armGroupLabels': ['Oral ADAIR + Intranasal Placebo', 'Oral Placebo + Intranasal Placebo', 'Oral Placebo + Intranasal crushed dextroamphetamine sulfate', 'Oral Placebo + Intranasal manipulated ADAIR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84124', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Vallon Investigational Site', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Timothy Whitaker, M', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Vallon Pharmaceuticals, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Currently there is no IPD plan'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vallon Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}