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Ketamine for OUD and Comorbid Depression (OUDCD)

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ClinicalTrials.gov Identifier: NCT05051449
Recruitment Status : Not yet recruiting
First Posted : September 21, 2021
Last Update Posted : November 1, 2021
Sponsor:
Information provided by (Responsible Party):
Annabelle Belcher, University of Maryland, Baltimore

Tracking Information
First Submitted Date  ICMJE September 10, 2021
First Posted Date  ICMJE September 21, 2021
Last Update Posted Date November 1, 2021
Estimated Study Start Date  ICMJE February 2022
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2021)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 10, 2021)
  • 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: AIM [ Time Frame: One month ]
    Acceptance will be assessed via scores on the Acceptability of the Intervention Measure: distribution summarized with mean and 95% C.I.
  • 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2021)
  • Patient Treatment Retention [ Time Frame: Three months ]
    One-month (30-day) methadone treatment retention as a binomial (yes/no) variable outcome.
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine for OUD and Comorbid Depression (OUDCD)
Official Title  ICMJE Increasing Retention in Methadone Maintenance Treatment: Feasibility and Preliminary Efficacy of Ketamine for the Treatment of Patients With OUD and Comorbid Depression (OUDCD)
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Opioid Use Disorder
  • Depressive Disorder
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Ketamine
Intervention: Drug: Ketamine Hydrochloride
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 10, 2021)
6
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2024
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 ketamine, benzodiazepine, psychostimulants (cocaine, amphetamine, methamphetamine, or methylene-dioxymethamphetamine [MDMA]), phencyclidine (PCP), 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Annabelle Belcher, PhD 443-462-3400 Abelcher@som.umaryland.edu
Contact: Sarah Kattakuzhy, MD 443-691-4638 SKattakuzhy@ihv.umaryland.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05051449
Other Study ID Numbers  ICMJE HP-00096377
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Annabelle Belcher, University of Maryland, Baltimore
Study Sponsor  ICMJE University of Maryland, Baltimore
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Annabelle Belcher, PhD University of Maryland, Baltimore
PRS Account University of Maryland, Baltimore
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP