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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)

NCT ID: NCT04647903

Last Updated: 2021-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-05

Study Completion Date

2021-12-17

Brief Summary

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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

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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).

Conditions

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ADHD Narcolepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Oral Placebo + Intranasal manipulated ADAIR

Oral Placebo + Intranasal manipulated ADAIR 30 mg

Group Type EXPERIMENTAL

ADAIR 10 mg IR tablets

Intervention Type DRUG

manipulated ADAIR 3x10mg

Placebo

Intervention Type DRUG

placebo for oral and intranasal administration

Oral Placebo + Intranasal crushed dextroamphetamine sulfate

Oral Placebo + Intranasal crushed dextroamphetamine sulfate IR 30 mg

Group Type ACTIVE_COMPARATOR

d-amphetamine sulfate

Intervention Type DRUG

crushed d-amphetamine sulfate 3x10mg

Placebo

Intervention Type DRUG

placebo for oral and intranasal administration

Oral ADAIR + Intranasal Placebo

Oral ADAIR 30 mg + Intranasal Placebo

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

placebo for oral and intranasal administration

Oral Placebo + Intranasal Placebo

Oral Placebo + Intranasal Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo for oral and intranasal administration

Interventions

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ADAIR 10 mg IR tablets

manipulated ADAIR 3x10mg

Intervention Type DRUG

d-amphetamine sulfate

crushed d-amphetamine sulfate 3x10mg

Intervention Type DRUG

Placebo

placebo for oral and intranasal administration

Intervention Type DRUG

Other Intervention Names

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ADAIR dextroamphetamine sulfate

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vallon Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Timothy Whitaker, M

Role: STUDY_DIRECTOR

Vallon Pharmaceuticals, Inc.

Locations

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Vallon Investigational Site

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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VAL-104

Identifier Type: -

Identifier Source: org_study_id