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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)

Primary Purpose

ADHD, Narcolepsy

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ADAIR 10 mg IR tablets
d-amphetamine sulfate
Placebo
Sponsored by
Vallon Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ADHD

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Vallon Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Placebo Comparator

Arm Label

Oral Placebo + Intranasal manipulated ADAIR

Oral Placebo + Intranasal crushed dextroamphetamine sulfate

Oral ADAIR + Intranasal Placebo

Oral Placebo + Intranasal Placebo

Arm Description

Oral Placebo + Intranasal manipulated ADAIR 30 mg

Oral Placebo + Intranasal crushed dextroamphetamine sulfate IR 30 mg

Oral ADAIR 30 mg + Intranasal Placebo

Oral Placebo + Intranasal Placebo

Outcomes

Primary Outcome Measures

Drug Liking Emax Visual Analog Scale (VAS)
Peak effect for drug liking based on bipolar VAS from 0-100 scale

Secondary Outcome Measures

Take Drug Again Emax VAS
Peak effect for take drug again based on bipolar VAS from 0-100 scale
Overall Drug Liking Emax VAS
Peak effect for overall drug liking based on bipolar VAS from 0-100 scale
Plasma concentrations (PK parameters)
plasma concentrations of ADAIR and dextroamphetamine sulfate
Safety (adverse events)
Incidence of adverse events

Full Information

First Posted
November 13, 2020
Last Updated
December 28, 2021
Sponsor
Vallon Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04647903
Brief Title
Study to Evaluate the Abuse Liability, Pharmacokinetics, Safety and Tolerability of an Abuse-Deterrent d-Amphetamine Sulfate Immediate Release Formulation (ADAIR)
Acronym
SEAL
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
October 5, 2020 (Actual)
Primary Completion Date
December 17, 2021 (Actual)
Study Completion Date
December 17, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vallon Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD, Narcolepsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral Placebo + Intranasal manipulated ADAIR
Arm Type
Experimental
Arm Description
Oral Placebo + Intranasal manipulated ADAIR 30 mg
Arm Title
Oral Placebo + Intranasal crushed dextroamphetamine sulfate
Arm Type
Active Comparator
Arm Description
Oral Placebo + Intranasal crushed dextroamphetamine sulfate IR 30 mg
Arm Title
Oral ADAIR + Intranasal Placebo
Arm Type
Experimental
Arm Description
Oral ADAIR 30 mg + Intranasal Placebo
Arm Title
Oral Placebo + Intranasal Placebo
Arm Type
Placebo Comparator
Arm Description
Oral Placebo + Intranasal Placebo
Intervention Type
Drug
Intervention Name(s)
ADAIR 10 mg IR tablets
Other Intervention Name(s)
ADAIR
Intervention Description
manipulated ADAIR 3x10mg
Intervention Type
Drug
Intervention Name(s)
d-amphetamine sulfate
Other Intervention Name(s)
dextroamphetamine sulfate
Intervention Description
crushed d-amphetamine sulfate 3x10mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo for oral and intranasal administration
Primary Outcome Measure Information:
Title
Drug Liking Emax Visual Analog Scale (VAS)
Description
Peak effect for drug liking based on bipolar VAS from 0-100 scale
Time Frame
Up to 24 hours post-dose
Secondary Outcome Measure Information:
Title
Take Drug Again Emax VAS
Description
Peak effect for take drug again based on bipolar VAS from 0-100 scale
Time Frame
Up to 24 hours post dose
Title
Overall Drug Liking Emax VAS
Description
Peak effect for overall drug liking based on bipolar VAS from 0-100 scale
Time Frame
Up to 24 hours post dose
Title
Plasma concentrations (PK parameters)
Description
plasma concentrations of ADAIR and dextroamphetamine sulfate
Time Frame
Up to 36 hours post dose
Title
Safety (adverse events)
Description
Incidence of adverse events
Time Frame
Day 1 to Day 18

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy Whitaker, M
Organizational Affiliation
Vallon Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Vallon Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Currently there is no IPD plan

Learn more about this trial

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

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