Ketamine for OUD and Comorbid Depression (OUDCD)

Phase 1

Terminated

• Conditions: Opioid Use Disorder; Depressive Disorder
• Interventions: Drug: Ketamine Hydrochloride

• Registration Number: NCT05051449
• Lead Sponsor: University of Maryland, Baltimore

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-10
• Study First Submitted QC: 2021-09-10
• Study First Posted: 2021-09-21
• Study Start: 2022-04-04
• Primary Completion: 2023-11-17
• Study Completion: 2023-11-30
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ketamine	Ketamine Hydrochloride	-

Primary Outcome Measures

Name	Time	Method
Feasibility: Study Recruitment	One year	Feasibility will be assessed via participant recruitment: 50% of eligible patients approached will consent to participation in the pilot.
Feasibility: Study Retention	One year	75% of participants will be retained throughout the duration of ketamine infusion procedures
Patient Acceptability: Acceptability of the Intervention Measure (AIM)	One month	Acceptance will be assessed via scores on the Acceptability of the Intervention Measure (AIM): Distribution summarized with mean and 95% C.I. Scale values range from 1 to 5 with higher mean values representing greater agreement and/or acceptability.
Patient Acceptability: Engagement	One month	Engagement will be assessed via dosing records of observed ketamine administration: distribution of percentage of completed infusions per patient.

Secondary Outcome Measures

Name	Time	Method
Patient Treatment Retention	Three months	One-month (30-day) methadone treatment retention as a binomial (yes/no) variable outcome.
Changes in Psychiatric Diagnosis of Depression	One month	Assessment of changes in depression (MADRS score) will be made at baseline and on the final study day based on a Minimal Clinically Important Difference (MCID) defined change of 1.9 points
Changes in Depressive Symptoms	One month	Assessment of changes in symptoms of depression, measured with the Patient Health Questionnaire (PHQ-9) will be made at baseline and on the final study day.

Trial Locations

Locations (1)

University of Maryland Baltimore; 🇺🇸 Baltimore, Maryland, United States