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.
- Opioid Use Disorder
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
11 Primary · 22 Secondary · Reporting Duration: 52 days
Trial Safety
Phase-Based Safety
Awards & Highlights
Trial Design
1 Treatment Group
LYN-014 Extended-Release Levomethadone HCl
1 of 1
Experimental Treatment
1 Treatment Group
Primary Treatment: Methadone · No Placebo Group · Phase 1
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 59 · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| Michigan | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| New York State Psychiatric Institute / Columbia | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
Frequently Asked Questions
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" - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
Does the trial allow minors to participate?
"This clinical trial is open to those adults aged 18 and below 59." - Anonymous Online Contributor
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." - Anonymous Online Contributor