Health Condition 1: F102- Alcohol dependence
Conditions
Interventions
Intervention1: Oral Ketamine: For the first session, the patient will remain on an empty stomach for 4 hours before the ketamine dose. A dose of 150 mg ketamine (50 mg/mL, clear solution) will be mixe
Sponsors
Dr Deepak S Ghadigaonkar
Eligibility
Inclusion criteria
Inclusion criteria: 1. Either gender. 2. Age between 18 to 65 years. 3. Diagnosis of Alcohol Use Disorder (AUD)- Severe, diagnosed by a psychiatrist per Diagnostic and Statistical Manual 5 TR (DSM-V TR). 4. Severity of Alcohol Dependence Questionnaire (SADQ) score of 31 or more signifying severe dependence. 5. Inadequate response to standard treatment for AUD defined as follows (both criteria should be met): • Relapse to heavy drinking within three months of discharge in at least one previous admission. This is based on the DSM-5 TR definition of early remission in AUD. • Failed trials of at least one of the standard or off-label medications (Acamprosate, Baclofen, Topiramate, Naltrexone, Disulfiram) as evidenced by relapse to heavy drinking while on treatment or following non-compliance. 6. Willingness to come for fortnightly sessions and for blood tests. 7. For females of reproductive age, willingness to take effective contraception from the day of signing the consent form until six weeks after treatment discontinuation.
Exclusion criteria
Exclusion criteria: 1. Currently taking any other relapse prevention medication 2. Uncontrolled hypertension (systolic 140 mm Hg or greater and diastolic 90 mm Hg or greater). 3. Body mass index (BMI) more than 30. 4. History or presence of a psychotic illness 5. Current or past history of recreational use of any prescription drug. 6. Current or past history of any other SUD except nicotine and cannabis. 7. Intellectual disability, sensory impairment or uncommunicative patients where obtaining consent and assessment of craving, adverse effects are precluded. 8. Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) less than 60 mL/min/1.73 m2 as calculated using Modification of Diet in Renal Disease formula (MDRD). 9. Severe Alcoholic hepatitis or end-stage liver disease as defined by a MELD score (Model of end-stage liver disease) more than or equal to 21. 10. Unstable angina. 11. History of intracranial mass lesion or glaucoma 12. History of an allergic reaction to ketamine. 13. Pregnant or breastfeeding currently.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the relapse rates in patients receiving oral ketamine against those receiving oral midazolam. The relapse rates will be calculated based on the primary endpoint of a heavy drinking episode within three months of discharge from hospital. The secondary endpoints of time to relapse, number of relapses and treatment discontinuation will be consodered.Timepoint: T0 is the time of first treatment session. T1 is at 2 weeks from T0. T2 is at 4 weeks from T0. T3 is at 6 weeks from T0. T4 is at 8 weeks from T0. T5 is at 10 weeks from T0. T6 is at 12 weeks from T0. | — |
Secondary
| Measure | Time frame |
|---|---|
| The pharmacokinetic parameters of oral ketamine in adults with a population pharmacokinetic framework as it can handle unbalanced (unequal number of samples given by different subjects), unstructured (variable time of collection of samples with respect to drug administration) and sparse data.Timepoint: T0 is the time of first ketamine session.;The tolerability and safety of oral ketamine in alcoholo use disorder. This will be assessed using a multimonitor with breathing rate, heart rate, non-invasive blood pressure, and SpO2 probe during the sessions. Other scales used will be: 1) Clinician-Administered Dissociative States Scale (CADSS) before the session and at 30 minutes after ingestion, 2) 4 items positive sub-scale of Brief Psychiatric Rating Scale (BPRS) before and at 60 minutes after ingestion, 3) Observer’s assessment of alertness/sedation scale (OAASS) before, at 30 minutes and at 60 minutes of ingestion, 4) Bladder Pain Interstitial Cystitis Symptom Score (BPICSS) before each session starting with the second session, 5) 5 Item, Likert scale version of Drug Effect Questionnaire (DEQ) at 30 minutes after ingestion in each session, 6) Assessment for vomiting, nausea, retching, 7) Other treatment-emergent adverse eventTimepoint: T0 is the time of first treatment session. T1 is at 2 weeks from T0. T2 is at 4 weeks from T0. T3 is at 6 weeks from T0. T4 is at 8 weeks from T0. T5 is at 10 weeks from T0. T6 is at 12 weeks from T0.;The mediators of change in the drinking behaviour, as assessed for general health and depressive/anxiety symptoms using Hamilton’s depression rating scale (HDRS), State and Trait Anxiety Inventory (STAI), Short Form 12 (SF 12).Timepoint: T0 is the time of first treatment session. T1 is at 2 weeks from T0. T2 is at 4 weeks from T0. T3 is at 6 weeks from T0. T4 is at 8 weeks from T0. T5 is at 10 weeks from T0. T6 is at 12 weeks from T0. | — |
Countries
India
Contacts
Public ContactDr Deepak S Ghadigaonkar
National Institute of Mental Health and Neuro Sciences (NIMHANS), Bengaluru
Outcome results
None listed