ADHD Clinical Trial
— SEALOfficial 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
Verified date | December 2021 |
Source | Vallon Pharmaceuticals, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 55 |
Est. completion date | December 17, 2021 |
Est. primary completion date | December 17, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | Vallon Investigational Site | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
Vallon Pharmaceuticals, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Drug Liking Emax Visual Analog Scale (VAS) | Peak effect for drug liking based on bipolar VAS from 0-100 scale | Up to 24 hours post-dose | |
Secondary | Take Drug Again Emax VAS | Peak effect for take drug again based on bipolar VAS from 0-100 scale | Up to 24 hours post dose | |
Secondary | Overall Drug Liking Emax VAS | Peak effect for overall drug liking based on bipolar VAS from 0-100 scale | Up to 24 hours post dose | |
Secondary | Plasma concentrations (PK parameters) | plasma concentrations of ADAIR and dextroamphetamine sulfate | Up to 36 hours post dose | |
Secondary | Safety (adverse events) | Incidence of adverse events | Day 1 to Day 18 |
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