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Study of LYN-014 in Individuals With Opioid Use Disorder Who Are Stable on Methadone Therapy

NCT05251376 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2023-01-19

No results posted yet for this study

Summary

A Phase 1, Single Dose, Open-label, Safety, Tolerability, and Pharmacokinetic Study of LYN-014 in Individuals with Opioid Use Disorder Who are Stable on Methadone Therapy

Conditions

  • Opioid Use Disorder, Moderate

Interventions

DRUG

Levomethadone HCl

One dose given orally on Day 8 of the study.

DRUG

Methadone

Daily usual oral dose given on Day 1 and Day 2 of the study.

DRUG

Morphine Sulfate

Administered daily and as needed from Day 3 of the study until subject back on usual daily methadone dose.

DIAGNOSTIC_TEST

x-ray

Abdominal x-rays done at specific study timepoints to assess the location of the LYN-014.

DIAGNOSTIC_TEST

blood tests

Done at specific timepoints throughout the study for PK (pharmacokinetics), genotyping and safety labs.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Lyndra Inc.

    lead INDUSTRY

Principal Investigators

  • Richard Scranton, MD, MPH · Lyndra Therapeutics INC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-28
Primary Completion
2022-12-19
Completion
2022-12-19
FDA Drug
Yes

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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 NCT05251376 on ClinicalTrials.gov