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).

Sponsored by the University of Maryland, Baltimore, the study addresses the challenge of retention and adherence in methadone treatment, particularly for patients with OUDCD. The trial seeks to assess the feasibility and patient acceptance of ketamine alongside methadone treatment, with a focus on improving treatment outcomes for OUD patients with comorbid depression.

Participants will receive six intravenous infusions of ketamine over a two-week period, administered three times per week. The study will evaluate recruitment feasibility, retention rates, patient acceptance, and engagement. Additionally, it will assess changes in psychiatric diagnosis of depression, depressive symptoms, substance use, and other relevant outcomes.

Eligible participants are aged between 18 and 65 years, have moderate-to-severe opioid or heroin use disorder, and exhibit depressive symptoms. Exclusion criteria include certain medical conditions and prior ketamine or PCP dependence. The study commenced in April 2022 and is expected to conclude by November 2024.

Topic Opioid Use Disorder Depression Addiction
Compound Ketamine
Country United States of America
Visit trial
Status Recruiting
Results Published No
Start date 04 April 2022
End date 01 November 2024
Phase Phase I
Design Open
Type Interventional
Generation First
Participants 6
Sex All
Age 18- 65
Therapy No

Trial Details

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.

NCT Number NCT05051449

Data attribution

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