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Ketamine for OUD and Comorbid Depression (OUDCD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05051449
Recruitment Status : Recruiting
First Posted : September 21, 2021
Last Update Posted : April 15, 2022
Sponsor:
Information provided by (Responsible Party):
Annabelle Belcher, 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.

Condition or disease Intervention/treatment Phase
Opioid Use Disorder Depressive Disorder Drug: Ketamine Hydrochloride Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : April 4, 2022
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ketamine Drug: Ketamine Hydrochloride
Ketamine will be administered by a nurse in a 2-week treatment phase, during which participants will receive six IV infusions of 0.5 mg/kg (over 40-50 minutes) ketamine three times per week. Infusion days for patients will be on Mondays, Wednesdays, and Fridays, +/- 1 day. Ketamine infusions will take place at the UMB General Clinical Research Center (GCRC). The GCRC nurse will deliver ketamine within a private exam room. The infusions will last 40-50 min, and the participant will be observed by the GCRC clinical staff for 2 hours post-infusion. Vital signs will be monitored throughout the treatment; specifically, blood pressure, pulse ox and heart rate will be checked prior to treatment, q20 minutes during infusion, and q30-60 minutes after infusion for up to three hours.




Primary Outcome Measures :
  1. 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.

  2. Feasibility: Study Retention [ Time Frame: One year ]
    75% of participants will be retained throughout the duration of ketamine infusion procedures

  3. 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.

  4. 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 Outcome Measures :
  1. Patient Treatment Retention [ Time Frame: Three months ]
    One-month (30-day) methadone treatment retention as a binomial (yes/no) variable outcome.

  2. Changes in Psychiatric Diagnosis of Depression [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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): A total of 3 points or less on the PC-PTSD-5
  • From screening for study eligibility (Study Contact Day 1): Have had no prior sustained experience/dependence on ketamine (i.e., must answer "no" to all four questions on the ketamine 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): Baseline urine drug test positive for benzodiazepine, psychostimulants (cocaine, amphetamine, methamphetamine, or methylene-dioxymethamphetamine [MDMA]), methadone, or buprenorphine
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05051449


Contacts
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Contact: Annabelle Belcher, PhD 443-462-3400 Abelcher@som.umaryland.edu
Contact: Sarah Kattakuzhy, MD 443-691-4638 SKattakuzhy@ihv.umaryland.edu

Locations
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United States, Maryland
University of Maryland Baltimore Recruiting
Baltimore, Maryland, United States, 21223
Sponsors and Collaborators
University of Maryland, Baltimore
Investigators
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Principal Investigator: Annabelle Belcher, PhD University of Maryland, Baltimore
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Responsible Party: Annabelle Belcher, Assistant Professor, University of Maryland, Baltimore
ClinicalTrials.gov Identifier: NCT05051449    
Other Study ID Numbers: HP-00096377
First Posted: September 21, 2021    Key Record Dates
Last Update Posted: April 15, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Disease
Opioid-Related Disorders
Depressive Disorder
Pathologic Processes
Mood Disorders
Mental Disorders
Narcotic-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action