Increasing Retention in Methadone Maintenance Treatment: Feasibility and Preliminary Efficacy of Ketamine for the Treatment of Patients With OUD and Comorbid Depression (OUDCD)
Overview
- Phase
- Phase 1
- Intervention
- Ketamine Hydrochloride
- Conditions
- Opioid Use Disorder
- Sponsor
- University of Maryland, Baltimore
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Feasibility: Study Recruitment
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
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.
Investigators
Annabelle Belcher
Assistant Professor
University of Maryland, Baltimore
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Ketamine
Intervention: Ketamine Hydrochloride
Outcomes
Primary Outcomes
Feasibility: Study Recruitment
Time Frame: One year
Feasibility will be assessed via participant recruitment: 50% of eligible patients approached will consent to participation in the pilot.
Feasibility: Study Retention
Time Frame: One year
75% of participants will be retained throughout the duration of ketamine infusion procedures
Patient Acceptability: Acceptability of the Intervention Measure (AIM)
Time Frame: 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
Time Frame: One month
Engagement will be assessed via dosing records of observed ketamine administration: distribution of percentage of completed infusions per patient.
Secondary Outcomes
- Patient Treatment Retention(Three months)
- Changes in Psychiatric Diagnosis of Depression(One month)
- Changes in Depressive Symptoms(One month)