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

NCT04232644 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2020-01-18

No results posted yet for this study

Summary

This is a pilot randomized, double-blind, active-controlled, 2-treatment, crossover study to evaluate the PK, user experience and abuse liability of manipulated ADAIR compared to a manipulated commercially-available d-amphetamine sulfate IR formulation administered intranasally in non-dependent recreational stimulant users. The study is comprised of 4 phases: Screening, Qualification, Treatment, and Follow-up/Early Termination.

Conditions

Interventions

DRUG

ADAIR 10mg IR capsules

manipulated ADAIR IR 3x10 mg capsules

DRUG

Crushed d-amphetamine sulfate IR tablets

crushed d-amphetamine sulfate IR 6 x 5 mg tablets

Sponsors & Collaborators

  • Vallon Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Timothy Whitaker, MD · Vallon Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-27
Primary Completion
2019-07-17
Completion
2019-07-17
FDA Drug
Yes

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04232644 on ClinicalTrials.gov