This double-blind, placebo-controlled therapeutic exploratory trial (n=60) conducted by the University of Cyprus, investigates the efficacy of ketamine in preventing relapse in patients with Opioid-Use Disorders (OUD). The trial, named PROUD, is currently ongoing.
The primary objective of the trial is to assess the effectiveness of a two-week regimen of subanesthetic antidepressant doses of ketamine (0.5 mg/kg) as an adjunct treatment. The goals include improving opioid substitution treatment (OST) retention, reversing negative affective behaviors, and prolonging/maintaining abstinence in opioid addicts undergoing OST. Additionally, the study aims to identify biomarkers predicting vulnerability to relapse during abstinence.
The trial involves adult participants (18-65 years old) with moderate-to-severe opioid or heroin use disorder, accepting maintenance care for OUD. Exclusion criteria include certain medical conditions, mental illnesses, and recreational use of ketamine or PCP. The trial employs a placebo (solution for injection) alongside ketamine and involves various assessments, including heart rate variability, stress response biomarkers, and neural activity measured via EEG.
The study is double-blind with two treatment arms (ketamine and placebo), and its endpoint is set at 9 months after the last ketamine infusion. The duration of the trial in the Member State of Cyprus is estimated to be 2 years. The Competent Authority decision was authorized on November 16, 2022, and the Ethics Committee provided a favourable opinion on April 28, 2022. The trial’s sponsor is the University of Cyprus, with support from the Research and Innovation Foundation.
Sponsor’s protocol code EXCELLENCE/0421/0543v1.
Trial Details
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