Methadone and buprenorphine comprise a first-line, evidence-based opioid substitution treatment (OST) for OUD patients. Unfortunately, retention and adherence to OST treatment is currently a major challenge in the treatment of OUDs. Another major challenge for opioid addicts who are recovering from addiction is the maintenance of a drug-free state due to the negative affect associated with protracted opioid abstinence, including depression, anhedonia, and anxiety. MedDRA version: 20.1 Level: LL
Conditions
Interventions
Trade Name: Ketamin Inresa 10 ml
Solution for injection 500 mg
50 mg/ml
Product Name: Ketamin Inresa 10 ml Solution for injection 500 mg 50 mg/ml
Pharmaceutical Form: Solution for injection
INN or Pro
Sponsors
University of Cyprus
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (i) age between 18 to 65 years old; (ii) daily use of illicit opioids (iii) fulfillment of DSM-5/ICD-10 criteria for moderate-to-severe opioid or heroin use disorder; (iii) acceptance into maintenance care for treatment of opioid or heroin use disorder; (iv) retained in buprenorphine/naloxone treatment since their intake on the preceding day; (v) achieved a PHQ-9 score of at least 10 points. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: (i) electrocardiogram (ECG) findings of tachycardia, prior myocardial infarction, myocardial ischemia, or aberrant conduction; (iii) baseline urine drug test positive for benzodiazepine, methadone, or buprenorphine; (iv) self-report of recent prescribed or illicit benzodiazepine use (“Xanies”, or “bars”); (v) urine screen positive for pregnancy; (vi) hypertension, defined by a systolic blood pressure (SBP) > 140 mmHg or a diastolic blood pressure (DBP) > 90 mmHg; (vii) 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); (viii) any clinically significant abnormal findings from health and physical examination; (ix) any indication of serious mental illness or psychiatric disorder from the attending’s evaluation notes. Additionally: (i) subjects who meet DSM-5 criteria for current bipolar disorder; (ii) subjects who meet DSM-5 criteria for current or history of psychotic spectrum disorders; (iii) past or current presence of psychotic symptoms, or diagnosis of a lifetime psychotic disorder including schizophrenia or schizoaffective disorder; (iv) current or previous recreational use of ketamine or PCP.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The long-term aim of the project is to identify novel, faster-acting medications for (i) promoting retention to the opioid substitution treatment, (ii) reversing/preventing comorbid affective disorders and (iii) maintain opioid abstinence in abstaining opioid dependent patients. In addition, PROUD aims to identify novel biomarkers predicting vulnerability to relapse to opioid-taking during abstinence. Our studies will contribute to improved treatment strategies for prevention of relapse to opioid use following long-term abstinence in patients.;Secondary Objective: Not applicable;Primary end point(s): * We will assess the efficacy of a two-week regimen of subanesthetic antidepressant doses of ketamine (0.5 mg/kg) as an adjunct treatment to: (i) Improve OST treatment retention; (ii) reverse comorbid negative affective behaviors (including depression, anhedonia, suicidal thoughts and anxiety); (iii) prolong/maintain abstinence, in abstaining opioid addicts undergoing opioid-substitution treatment (OST). * Emotion regulation ability (as indexed via heart rate variability; HRV), stress response biomarkers (norepinephrine, epinephrine (catecholamines), adrenocorticotrophic hormone (ACTH) and cortisol) and changes in neural activity (measured via EEG spectral analysis) will be assessed in OUD patients prior and after exposure to a mild psychological stressor, prior to quitting opioids. The aim here is to examine whether these psycho-bio-neurophysiological markers alone or their reciprocal interactions can predict: (i) vulnerability to relapse to opioid-taking during abstinence in placebo-treated patients; (ii) ketamine’s treatment outcomes in the patient treatment group that will receive ketamine infusions. ;Timepoint(s) of evaluation of this end point: Throughout the study and after the end of ketamine administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): * Using EEG measurements, we will assess whether changes in cortical neural activity after administration of ketamine are associated or can predict ketamine’s efficacy to improve OST treatment retention, reverse comorbid negative affective behaviors and prolong/maintain abstinence.;Timepoint(s) of evaluation of this end point: Prior to ketamine administration and 1 day after administration | — |
Countries
Cyprus
Contacts
Public ContactPanos Zanos
University of Cyprus
Outcome results
None listed