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) 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.

Topic Opioid Use Disorder Addiction
Compound Ketamine Placebo
Visit trial
Status Active, not recruiting
Results Published No
Start date 28 April 2022
Phase Phase II
Design Blinded
Type Interventional
Generation First
Participants 60
Sex All
Age 18- 65
Therapy Yes

Trial Details

This ongoing double-blind, placebo-controlled trial (PROUD) by the University of Cyprus explores the efficacy of Ketamine in preventing relapse in Opioid-Use Disorder patients. With 60 participants, aged 18-65, the trial aims to improve opioid substitution treatment retention, reverse negative affective behaviors, and maintain abstinence. Using subanesthetic doses of ketamine, the study includes placebo, assesses biomarkers predicting relapse vulnerability, and utilizes measures like heart rate variability and EEG.

NCT Number 2022-001997-70

Data attribution

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