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NCT05051449 · ClinicalTrials.gov registry record · Phase 1

Ketamine for OUD and Comorbid Depression (OUDCD)

A Phase 1 study, sponsored by University of Maryland, Baltimore.

Terminated
Registry status
Phase 1
Development phase
5
Enrollment target

NCT05051449: Clinical Trial Phase 1 study, sponsored by University of Maryland, Baltimore.

NCT05051449 is a Phase 1 study that was terminated before completion, run by University of Maryland, Baltimore. The registered enrollment target is 5 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05051449, a Phase 1 study, was terminated before completion, sponsored by University of Maryland, Baltimore.

TERMINATED
Registry status
Phase 1
Development phase
5 participants
Enrollment target

Study Summary

Methadone is a first-line, evidence-based treatment for opioid use disorder (OUD). Unfortunately, retention and adherence in methadone treatment is a major challenge. OUD patients frequently present with co-morbid depression (OUDCD), a risk factor for poor OUD treatment outcomes, overdose, and suicide. The last two decades have seen an exciting and transformational development in the treatment of depression - ketamine. As a safe, rapid-acting anti-depressant deliverable within the context of methadone maintenance treatment, ketamine could feasibly change the landscape of treatment for OUD patients with comorbid depression. This proposal seeks to evaluate implementation outcomes (feasibility and patient acceptance) as well as preliminary efficacy of ketamine on methadone treatment outcomes for OUD patients (n=6) with comorbid depression and depressive symptoms presenting for methadone treatment.

Primary Outcome

Feasibility will be assessed via participant recruitment: 50% of eligible patients approached will consent to participation in the pilot.

Interventions

  • DRUG Ketamine Hydrochloride

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2022-04-04
Est. Completion 2023-11-30
Phase Phase 1
University of Maryland, Baltimore

560 total trials

Why NCT05051449 stopped before completion

NCT05051449 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 1 intervention - of which Ketamine Hydrochloride is the first listed.

NCT05051449 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05051449 about?

NCT05051449 is a clinical study titled "Ketamine for OUD and Comorbid Depression (OUDCD)". Methadone is a first-line, evidence-based treatment for opioid use disorder (OUD). Unfortunately, retention and adherence in methadone treatment is a major challenge. OUD patients frequently present with co-morbid depression (OUDCD), a risk factor for poor OUD treatment outcomes, overdose, and suici...

What is the current status of trial NCT05051449?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2022-04-04. Estimated completion is 2023-11-30.

What interventions are being tested in trial NCT05051449?

The interventions under investigation include: Ketamine Hydrochloride (DRUG).

Who is sponsoring clinical trial NCT05051449?

This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05051449's enrollment target sits among peer trials

5 1989th of 2000 higher than 6 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05051449, the US trial registry maintained by the National Library of Medicine. NCT05051449 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.