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

Last updated: December 28, 2021
Sponsor: Vallon Pharmaceuticals, Inc.
Overall Status: Completed

Phase

1

Condition

Attention Deficit/hyperactivity Disorder (Adhd - Adults)

Narcolepsy

Treatment

N/A

Clinical Study ID

NCT04647903
VAL-104
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

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 allergiesin 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 priorto 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)

Study Design

Total Participants: 55
Study Start date:
October 05, 2020
Estimated Completion Date:
December 17, 2021

Study 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).

Connect with a study center

  • Vallon Investigational Site

    Salt Lake City, Utah 84124
    United States

    Site Not Available

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