Clinical TrialOpioid Use Disorder (OUD)KetaminePlaceboActive not yet recruiting

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.

Target Enrollment
60 participants
Study Type
Phase II interventional
Design
Randomized, double Blind

Detailed Description

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.

Study Protocol

Preparation

sessions

Dosing

sessions

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Ketamine IV

experimental

Adjunctive subanaesthetic ketamine infusion regimen (0.5 mg/kg) versus placebo over a two-week treatment course.

Interventions

  • Ketamine0.5 mg/kg
    via IV• two-week regimen

    Subanaesthetic antidepressant dosing as adjunct to opioid-substitution treatment.

Placebo IV

inactive

Intravenous placebo solution matched to ketamine infusions.

Interventions

  • Placebo
    via IV• two-week regimen

    Placebo intravenous solution; saline matched to active infusions.

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • (i) Age 18–65 years.
  • (ii) Daily use of illicit opioids.
  • (iii) Fulfilment of DSM-5/ICD-10 criteria for moderate-to-severe opioid or heroin use disorder.
  • (iv) Acceptance into maintenance care for treatment of opioid or heroin use disorder.
  • (v) Retained in buprenorphine/naloxone treatment since their intake on the preceding day.
  • (vi) PHQ-9 score of at least 10 points.

Exclusion Criteria

  • (i) ECG findings of tachycardia, prior myocardial infarction, myocardial ischemia, or aberrant conduction.
  • (ii) Baseline urine drug test positive for benzodiazepine, methadone, or buprenorphine.
  • (iii) Self-report of recent prescribed or illicit benzodiazepine use.
  • (iv) Urine screen positive for pregnancy.
  • (v) Hypertension defined as SBP >140 mmHg or DBP >90 mmHg.
  • (vi) Clinically significant abnormal laboratory values, physical exam findings or self-reported medical conditions for which a transient increase in blood pressure could be significantly detrimental (e.g., cardiovascular disease).
  • (vii) Any clinically significant abnormal findings from health and physical examination.
  • (viii) Any indication of serious mental illness or psychiatric disorder on evaluation, including current bipolar disorder or current/history of psychotic spectrum disorders.
  • (ix) Past or current presence of psychotic symptoms or lifetime psychotic disorder (e.g., schizophrenia, schizoaffective disorder).
  • (x) Current or previous recreational use of ketamine or PCP.

Study Details

  • Status
    Active not yet recruiting
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment60 participants
  • Timeline
    Start: 2022-04-28
  • Compounds
    KetaminePlacebo
  • Topic
    Opioid Use Disorder (OUD)

Locations

Cyprus

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