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Methadone for Opioid Use Disorder

Phase 1
Waitlist Available
Led By Richard Scranton, MD, MPH
Research Sponsored by Lyndra Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 days
Awards & highlights

Study Summary

This trial is testing a new drug, LYN-014, to see if it is safe and tolerated in people with opioid use disorder who are already stable on methadone therapy.

Eligible Conditions
  • Opioid Use Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To characterize the PK of levomethadone for LYN-014 (AUC0-20)
To characterize the PK of levomethadone for LYN-014 (AUC0-t)
To characterize the PK of levomethadone for LYN-014 (AUC0-∞t)
+8 more
Secondary outcome measures
To assess gastrointestinal (GI) transit and exit properties of LYN 014.
To characterize the PK of LYN 014 compared with that of daily methadone Cmax Extended Release to Cmax Immediate Release
To characterize the PK of methadone enantiomers after methadone dosing (AUC0-24)
+19 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: LYN-014 Extended-Release Levomethadone HClExperimental Treatment5 Interventions
Extended-release levomethadone HCl 187 mg administered orally once on Day 8 of the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methadone
FDA approved
x-ray
2016
N/A
~8000
blood tests
2018
N/A
~370
Morphine
FDA approved

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,464 Previous Clinical Trials
2,618,593 Total Patients Enrolled
Lyndra Inc.Lead Sponsor
5 Previous Clinical Trials
168 Total Patients Enrolled
Richard Scranton, MD, MPHPrincipal InvestigatorLyndra Therapeutics INC
2 Previous Clinical Trials
117 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I a viable candidate to join this research effort?

"This research is recruiting for 16 individuals, between 18 and 59 years old, who are suffering from drug abuse. The following criteria must be met: Male or female aged ≥18 and ≤59 years; BMI of ≥18 kg/m2 to ≤33 kg/m2; Moderate to severe OUD according DSM-5 standards; Stably engaged in a methadone program with regular attendance and negative urine samples (besides cannabis); Provide contact information for the methadone clinic they attend; Agree that study physician can contact their clinician managing transition into the trial and back out again afterwards.; Be available throughout the entirety of the"

Answered by AI

What is the current participant count for this experiment?

"This clinical trial requires 16 participants who meet the prerequisites. Prospective patients can apply at New york State Psychiatric Institute / Columbia in New York, and Hassman Research Institute, LLC in Berlin, NJ."

Answered by AI

Has the Federal Drug Administration sanctioned Methadone for clinical use?

"Our team has determined that Methadone is relatively untested, thus it achieved a score of 1. This assessment was based on the fact that this trial is in Phase 1 and there exists limited data to assess its safety or efficacy."

Answered by AI

Are there still vacancies available in this clinical trial?

"Correct. According to clinicaltrials.gov, this scientific research endeavour is currently seeking volunteers; it was initially posted on February 28th 2022 and recently updated October 21st 2022. The study requires the participation of 16 individuals across 3 different sites."

Answered by AI

Does the trial allow minors to participate?

"This clinical trial is open to those adults aged 18 and below 59."

Answered by AI

What are the key aims of this clinical experiment?

"According to the research sponsor, Lyndra Inc., this trial will last 52 days and its primary objective is to ascertain the pharmacokinetics (PK) of levomethadone for LYN-014 at its period of minimum concentration. Additionally, secondary outcomes that need to be measured include ascertaining Cmax (Maximum Concentration), evaluating possible conversion from Levomethadone to Dextromethadone in regards to Cmax (maximum concentration), as well as determining Tmin (Time at Minimum Concentration) concerning the PKs of methadone enantiomers after a dose of methadone."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
Michigan
How old are they?
18 - 65
What site did they apply to?
New York State Psychiatric Institute / Columbia
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I want off opoids.
PatientReceived 1 prior treatment
~0 spots leftby Apr 2025