Efficacy of Ketamine for the Prevention of Relapse in Patients with Opioid-Use Disorders (OUD)
This double-blind, placebo-controlled therapeutic exploratory trial (n=60; PROUD) tests a two-week adjunctive subanaesthetic ketamine regimen (0.5 mg/kg IV) to improve retention in opioid-substitution treatment and prevent relapse in patients with opioid-use disorder.
Details
PROUD is a Phase II, randomised, double-blind, placebo-controlled trial conducted at a single site in Cyprus evaluating whether a two-week regimen of subanaesthetic ketamine (0.5 mg/kg IV) adjunctive to opioid-substitution treatment improves retention and reduces relapse in people with opioid-use disorder.
Secondary objectives include assessment of ketamine’s effects on comorbid negative affect (depression, anhedonia, anxiety) and identification of biomarkers and EEG/neurophysiological predictors of vulnerability to relapse.
Outcomes include treatment retention, measures of affective symptoms, relapse rates up to nine months after last infusion, heart rate variability and stress biomarkers, and EEG spectral analyses.