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TerminatedPhase 1

Ketamine for OUD and Comorbid Depression (OUDCD)

NCT05051449 · University of Maryland, Baltimore

Closed to entry
Status
Not accepting participants
Phase 1
Phase
5
Target enrolment
1
Study sites
1 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Feasibility: Study Recruitment

    Measured over One year

  • Feasibility: Study Retention

    Measured over One year

  • Patient Acceptability: Acceptability of the Intervention Measure (AIM)

    Measured over One month

  • Patient Acceptability: Engagement

    Measured over One month

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 65 Years
Ages
All
Sex
Accepted
Healthy volunteers
Inclusion Criteria * From NHS prescreen (no contact, Study Day 0): Between the ages of 18 to 65 years old * From NHS prescreen (no contact, Study Day 0): Daily use of illicit opioids * From NHS prescreen (no contact, Study Day 0): Fulfillment of DSM-5/ICD-10 criteria for moderate-to-severe opioid or heroin use disorder * From NHS prescreen (no contact, Study Day 0): Acceptance into methadone maintenance care for treatment of opioid or heroin use disorder * From screening for study eligibility (Study Contact Day 1): A total of 10 or more points on the PHQ-9 * From screening for study eligibility (Study Contact Day 1): Have had no prior sustained experience/dependence on ketamine or PCP (i.e., must answer "no" to all four questions on the ketamine/PCP screen) Exclusion Criteria * From NHS prescreen (no contact, Study Day 0): Patients transferring from another program of opioid agonist treatment * From NHS prescreen (no contact, Study Day 0): Electrocardiogram (ECG) findings of tachycardia, prior myocardial infarction, myocardial ischemia, or aberrant conduction * From NHS prescreen (no contact, Study Day 0): Self-report of recent prescribed or illicit benzodiazepine use ("Xannies", or "bars") * From NHS prescreen (no contact, Study Day 0): Urine screen positive for pregnancy * From NHS prescreen (no contact, Study Day 0): Stage 2 hypertension, defined by a systolic blood pressure (SBP) \> 140 mmHg or a diastolic blood pressure (DBP) \> 90 mmHg * From NHS prescreen (no contact, Study Day 0): Clinically significant abnormal laboratory values, physical exam findings or self-reported medical conditions for which a transient increase in blood pressure could be significantly detrimental (e.g., cardiovascular disease), as determined by the evaluating intake physician * From NHS prescreen (no contact, Study Day 0): Any clinically significant abnormal findings from intake health and physical examination * From NHS prescreen (no contact, Study Day 0): Any indication of serious mental illness or psychiatric disorder from the attending's evaluation notes * From Liver Function Screen (Study Contact Day 2): Baseline alkaline phosphatase \> 2.5 times the upper limit of normal * From Liver Function Screen (Study Contact Day 2): Baseline aspartate aminotransferase \> 3 times the upper limit of normal * From Psychiatric Evaluation (Study Contact Day 2) Current or previous recreational use of ketamine or PCP * From Psychiatric Evaluation (Study Contact Day 2): Subjects who meet DSM-5 criteria for current bipolar disorder * From Psychiatric Evaluation (Study Contact Day 2): Past or current presence of psychotic symptoms, or diagnosis of a lifetime psychotic disorder including schizophrenia or schizoaffective disorder * Subjects who meet DSM-5 criteria for current or history of psychotic spectrum disorders

Where

1 study site

FacilityCityRegionCountry
University of Maryland BaltimoreBaltimoreMarylandUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT05051449 on ClinicalTrials.gov →

Last updated in the registry 2024-03-07. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits