Clinical TrialOpioid Use Disorder (OUD)KetamineTerminated

Ketamine for OUD and Comorbid Depression (OUDCD)

This single-group assignment trial (n=6) aims to evaluate the feasibility and preliminary efficacy of ketamine as a treatment for patients with Opioid Use Disorder (OUD) and comorbid depression (OUDCD).

Target Enrollment

5 participants

Study Type

Phase I interventional

Design

Non-randomized

Registry

CTG / NCT05051449

Detailed Description

Open single-group treatment study in people with opioid use disorder and comorbid depression testing feasibility and preliminary efficacy of adjunctive ketamine during methadone maintenance; enrolled participants receive six IV infusions over two weeks.

Ketamine 0.5 mg/kg IV given three times weekly (Mon/Wed/Fri) for two weeks; infusions are 40–50 minutes with up to 2 hours post-infusion observation. Outcomes include feasibility, patient acceptance, and preliminary effects on depression and methadone treatment retention.

Study Protocol

Preparation

sessions

Dosing

6 sessions

50 min each

Integration

sessions

Study Arms & Interventions

Ketamine

experimental

Six IV infusions of ketamine (0.5 mg/kg) over 2 weeks (Mon/Wed/Fri).

Interventions

Ketamine0.5 mg/kg
via IV• six infusions over 2 weeks• 6 doses total
Infusions 40–50 min; observed up to 2 hours post-infusion; vitals monitored (BP, pulse ox, HR).

Participants

Ages

18 – 65

Sexes

Male & Female

BMI

Psychosis History

Inclusion 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

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

Study Details

Status
Terminated
Phase
Phase I
Type
interventional
Design
Non-randomized
Target Enrollment5 participants
Timeline
Start: 2022-04-04
End: 2024-11-01
Compound
Ketamine
Topic
Opioid Use Disorder (OUD)

Locations

University of Maryland Baltimore — Baltimore, Maryland, United States