ADHDPhase 1SEALNCT04647903
Study to Evaluate the Abuse Liability, Pharmacokinetics, Safety and Tolerability of an Abuse-Deterrent d-Amphetamine Sulfate Immediate Release Formulation (ADAIR)
A Phase 1 study testing ADAIR 10 mg IR tablets and d-amphetamine sulfate in people with ADHD and Narcolepsy, run by Vallon Pharmaceuticals, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- ADHD, Narcolepsy
- What is being tested?
- ADAIR 10 mg IR tablets and d-amphetamine sulfate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2020to 17 Dec 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Confirmed positive drug screening
- Positive alcohol breath test at screening / any Day -1
- Heavy smoker (> 20 cigarettes, > 8 pipefuls or > 8 cigars per day)
Trial locations and contacts
1 site in 1 country.
United States1 site
Vallon Investigational Site
Salt Lake City, Utah, 84124
About this study
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
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.
Read the 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).
- Conditions
- ADHD, Narcolepsy
- Being tested
- ADAIR 10 mg IR tablets, d-amphetamine sulfate, Placebo
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Narcolepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADAIR 10 mg IR tabletsDrug
Also called ADAIR
manipulated ADAIR 3x10mg
d-amphetamine sulfateDrug
Also called dextroamphetamine sulfate
crushed d-amphetamine sulfate 3x10mg
PlaceboDrug
placebo for oral and intranasal administration
| Study group | Role | What they receive |
|---|---|---|
| Oral Placebo + Intranasal manipulated ADAIR | Experimental | Oral Placebo + Intranasal manipulated ADAIR 30 mg Receives: Drug: ADAIR 10 mg IR tablets; Drug: Placebo |
| Oral Placebo + Intranasal crushed dextroamphetamine sulfate | Active comparator | Oral Placebo + Intranasal crushed dextroamphetamine sulfate IR 30 mg Receives: Drug: d-amphetamine sulfate; Drug: Placebo |
| Oral ADAIR + Intranasal Placebo | Experimental | Oral ADAIR 30 mg + Intranasal Placebo Receives: Drug: Placebo |
| Oral Placebo + Intranasal Placebo | Placebo comparator | Oral Placebo + Intranasal Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug Liking Emax Visual Analog Scale (VAS)
Peak effect for drug liking based on bipolar VAS from 0-100 scale
Measured: Up to 24 hours post-dose
Secondary outcomes (4)
Take Drug Again Emax VAS
Peak effect for take drug again based on bipolar VAS from 0-100 scale
Measured: Up to 24 hours post dose
Overall Drug Liking Emax VAS
Peak effect for overall drug liking based on bipolar VAS from 0-100 scale
Measured: Up to 24 hours post dose
Plasma concentrations (PK parameters)
plasma concentrations of ADAIR and dextroamphetamine sulfate
Measured: Up to 36 hours post dose
Safety (adverse events)
Incidence of adverse events
Measured: Day 1 to Day 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start5 Oct 2020
- Primary completion17 Dec 2021
- Study completion17 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vallon Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Timothy Whitaker, M, Study director, Vallon Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04647903
- Sponsor's protocol ID
- VAL-104
- Acronym
- SEAL
- Status last verified
- Dec 2021
- First submitted
- 13 Nov 2020
- Last updated
- 29 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Currently there is no IPD plan
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04647903
- Acronym / sponsor ID
- SEAL / VAL-104
- Conditions
- ADHD, Narcolepsy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Vallon Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 17 Dec 2021 (actual)
- Study completion
- 17 Dec 2021 (actual)
- First posted
- 1 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Oral Placebo + Intranasal manipulated ADAIR | Experimental | Drug: ADAIR 10 mg IR tablets, Drug: PlaceboOral Placebo + Intranasal manipulated ADAIR 30 mg |
| Oral Placebo + Intranasal crushed dextroamphetamine sulfate | Active comparator | Drug: d-amphetamine sulfate, Drug: PlaceboOral Placebo + Intranasal crushed dextroamphetamine sulfate IR 30 mg |
| Oral ADAIR + Intranasal Placebo | Experimental | Drug: PlaceboOral ADAIR 30 mg + Intranasal Placebo |
| Oral Placebo + Intranasal Placebo | Placebo comparator | Drug: PlaceboOral Placebo + Intranasal Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADAIR 10 mg IR tabletsAlso: ADAIRmanipulated ADAIR 3x10mg | Drug | Oral Placebo + Intranasal manipulated ADAIR |
| d-amphetamine sulfateAlso: dextroamphetamine sulfatecrushed d-amphetamine sulfate 3x10mg | Drug | Oral Placebo + Intranasal crushed dextroamphetamine sulfate |
| Placeboplacebo for oral and intranasal administration | Drug | Oral ADAIR + Intranasal Placebo, Oral Placebo + Intranasal Placebo, Oral Placebo + Intranasal crushed dextroamphetamine sulfate, Oral Placebo + Intranasal manipulated ADAIR |
Primary outcome
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
4 secondary outcomes
Take Drug Again Emax VAS
Time frame: Up to 24 hours post dose
Overall Drug Liking Emax VAS
Time frame: Up to 24 hours post dose
Plasma concentrations (PK parameters)
Time frame: Up to 36 hours post dose
Safety (adverse events)
Time frame: Day 1 to Day 18
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2021.
- Individual participant dataSharing planned: No. Currently there is no IPD plan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Whitaker, M study director
Vallon Pharmaceuticals, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ADAIR 10 mg IR tablets and d-amphetamine sulfate in people with ADHD and Narcolepsy, run by Vallon Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drug Liking Emax Visual Analog Scale (VAS) (time frame: Up to 24 hours post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2021.