Ketamine for OUD and Comorbid Depression (OUDCD)
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|ClinicalTrials.gov Identifier: NCT05051449|
Recruitment Status : Recruiting
First Posted : September 21, 2021
Last Update Posted : April 15, 2022
|Condition or disease||Intervention/treatment||Phase|
|Opioid Use Disorder Depressive Disorder||Drug: Ketamine Hydrochloride||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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
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
|Contact: Annabelle Belcher, PhD||443-462-3400||Abelcher@som.umaryland.edu|
|Contact: Sarah Kattakuzhy, MD||443-691-4638||SKattakuzhy@ihv.umaryland.edu|
|United States, Maryland|
|University of Maryland Baltimore||Recruiting|
|Baltimore, Maryland, United States, 21223|
|Principal Investigator:||Annabelle Belcher, PhD||University of Maryland, Baltimore|