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Study to Evaluate the Abuse Liability, Pharmacokinetics, Safety and Tolerability of an Abuse-Deterrent d-Amphetamine Sulfate Immediate Release Formulation (ADAIR) (SEAL)

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ClinicalTrials.gov Identifier: NCT04647903
Recruitment Status : Completed
First Posted : December 1, 2020
Last Update Posted : December 29, 2021
Sponsor:
Information provided by (Responsible Party):
Vallon Pharmaceuticals, Inc.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
ADHD Narcolepsy Drug: ADAIR 10 mg IR tablets Drug: d-amphetamine sulfate Drug: Placebo Phase 1

Detailed Description:

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.

A 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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 5, 2020
Actual Primary Completion Date : December 17, 2021
Actual Study Completion Date : December 17, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Oral Placebo + Intranasal manipulated ADAIR
Oral Placebo + Intranasal manipulated ADAIR 30 mg
 Drug: ADAIR 10 mg IR tablets
manipulated ADAIR 3x10mg
Other Name: ADAIR

Drug: Placebo
placebo for oral and intranasal administration
Active Comparator: Oral Placebo + Intranasal crushed dextroamphetamine sulfate
Oral Placebo + Intranasal crushed dextroamphetamine sulfate IR 30 mg
 Drug: d-amphetamine sulfate
crushed d-amphetamine sulfate 3x10mg
Other Name: dextroamphetamine sulfate

Drug: Placebo
placebo for oral and intranasal administration
Experimental: Oral ADAIR + Intranasal Placebo
Oral ADAIR 30 mg + Intranasal Placebo
 Drug: Placebo
placebo for oral and intranasal administration
Placebo Comparator: Oral Placebo + Intranasal Placebo
Oral Placebo + Intranasal Placebo
 Drug: Placebo
placebo for oral and intranasal administration


Outcome Measures
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Primary Outcome Measures :
  1. Drug Liking Emax Visual Analog Scale (VAS) [ Time Frame: Up to 24 hours post-dose ]
    Peak effect for drug liking based on bipolar VAS from 0-100 scale


Secondary Outcome Measures :
  1. Take Drug Again Emax VAS [ Time Frame: Up to 24 hours post dose ]
    Peak effect for take drug again based on bipolar VAS from 0-100 scale

  2. Overall Drug Liking Emax VAS [ Time Frame: Up to 24 hours post dose ]
    Peak effect for overall drug liking based on bipolar VAS from 0-100 scale

  3. Plasma concentrations (PK parameters) [ Time Frame: Up to 36 hours post dose ]
    plasma concentrations of ADAIR and dextroamphetamine sulfate

  4. Safety (adverse events) [ Time Frame: Day 1 to Day 18 ]
    Incidence of adverse events


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male or female volunteers, 18 to 55 years of age inclusive
  • Recreational drug abuse experience (>/= 10 times lifetime abuse of a CNS stimulant, >/= 1 abuse of CNS stimulant in the previous 3 months)
  • Prior intranasal recreational drug abuse experience
  • Body mass index (BMI) 18 to 33 kg/m2 inclusive

Exclusion Criteria:

  • History of any significant disease or disorder
  • History or current diagnosis of substance dependence (excluding caffeine and nicotine)
  • Any confirmed significant allergic reactions against any drug, or multiple allergies in the judgement of the investigator
  • Positive for hepatitis B, hepatitis C or HIV infection
  • Pregnant or lactating women
  • Participation in an investigational drug or device study within the last 30 days prior to Day 1 of the study
  • Confirmed positive drug screening
  • Positive alcohol breath test at screening / any Day -1
  • Heavy smoker (> 20 cigarettes, > 8 pipefuls or > 8 cigars per day)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04647903


Locations
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United States, Utah
Vallon Investigational Site
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
Vallon Pharmaceuticals, Inc.
Investigators
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Study Director: Timothy Whitaker, M Vallon Pharmaceuticals, Inc.
More Information
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Responsible Party: Vallon Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT04647903    
Other Study ID Numbers: VAL-104
First Posted: December 1, 2020    Key Record Dates
Last Update Posted: December 29, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Currently there is no IPD plan

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Narcolepsy
Disorders of Excessive Somnolence
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Amphetamine
Dextroamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
 Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors