Clinical trial NCT05051449: Ketamine for OUD and Comorbid Depression (OUDCD)
Official title: Increasing Retention in Methadone Maintenance Treatment: Feasibility and Preliminary Efficacy of Ketamine for the Treatment of Patients With OUD and Comorbid Depression (OUDCD)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Opioid Use Disorder
Depressive Disorder
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2021-09-21
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Feasibility: Study Recruitment
timeFrame: One year
measure: Feasibility: Study Retention
timeFrame: One year
measure: Patient Acceptability: Acceptability of the Intervention Measure (AIM)
timeFrame: One month
measure: Patient Acceptability: Engagement
timeFrame: One month
Secondary outcomes:
measure: Patient Treatment Retention
timeFrame: Three months
measure: Changes in Psychiatric Diagnosis of Depression
timeFrame: One month
measure: Changes in Depressive Symptoms
timeFrame: One month
Other outcomes:
measure: Self-report of illicit substance use
timeFrame: One month
measure: Subjective Opioid Withdrawal Scale (SOWS)
timeFrame: One monrh
measure: Objective Opioid Withdrawal Scale (OOWS)
timeFrame: One month
measure: Craving Assessment
timeFrame: One month
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: One month
measure: The Short Inventory of Problems-Revised (SIP-R)
timeFrame: One month
measure: Generalized Anxiety Disorder 7-item scale (GAD-7)
timeFrame: One month
measure: Acceptability of the Intervention (AIM)
timeFrame: One month
measure: Clinician Administered Dissociative Symptom Scale (CADSS-6)
timeFrame: Two weeks
measure: Drug Effects Questionnaire-5 (DEQ-5)
timeFrame: Two weeks
measure: Modified Aldrete
timeFrame: Two weeks
Locations:
city: Baltimore
country: United States
facility: University of Maryland Baltimore
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Annabelle Belcher, PhD
role: PRINCIPAL_INVESTIGATOR
References: