Clinical trial NCT06111339: Ketamine for OUD and Suicidal Ideation in the ED
Official title: Ketamine for the Treatment for Opioid Use Disorder and Suicidal Ideation in the Emergency Department
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Opioid Use Disorder
Suicidal Ideation
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2023-11-01
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a pilot, double-blind, placebo-controlled randomized clinical trial of individuals with opioid use disorder (OUD) with suicidal ideation in the emergency department (ED) to receive either a single infusion of ketamine 0.8mg/kg (n=25) or saline placebo (n=25). The primary aim is to evaluate the safety of the ketamine treatment. The secondary aim is to determine the preliminary efficacy of opioid- and suicide-related outcomes.

Detailed description: Individuals with opioid use disorder (OUD) seeking medical care in the emergency department (ED) will be first evaluated as per usual clinical care by the ED staff, including any acute medical treatment for overdose or any other acute medical issues needing treatment. For those who endorse suicidal ideation, after medical clearance, the standard medical care will involve the evaluation of patients by the psychiatry consult service in the ED. Patients evaluated by psychiatry who require further behavioral health care and do not have acute medical issues remain in the ED awaiting admission to an inpatient psychiatry unit or other linkages to care. Potential participants will be approached after the psychiatry evaluation is complete and a decision has been made to keep the patients in the ED for continued psychiatric care or admit them medically. After applying the full inclusion and exclusion criteria, those who remain eligible will be randomized to receive in a double-blind fashion either a single infusion of ketamine (0.8mg/kg) or a saline placebo. Safety assessments will be conducted during and after the receipt of ketamine or placebo, and at follow-up assessments after discharge from the emergency department of the hospital following inpatient psychiatric treatment.

Eligibility criteria: Inclusion/Exclusion Criteria:

To be eligible, individuals must be/have:

* English speaking adults aged 18 and above
* Diagnosed with DSM5 opioid use disorder, moderate or severe, or clinically suspected opioid use disorder
* Endorsing suicidal ideation sufficiently severe to meet criteria for referral to an inpatient psychiatric facility or a crisis stabilization unit
* Any prior history of an opioid overdose
* Medically cleared

Individuals with any of the following will be excluded:

* Any psychotic disorder or active homicidally
* Inability to perform consent due to impaired mental status
* Current substance intoxication or current (or within the past 1-month) mania, hypomania, mixed-episode, or psychosis
* Systolic blood pressure persistently elevated above 160mmHg, diastolic blood pressure greater than 100 mmHg, or heart rate \>100bmp, in the ED
* Clinical Opioid Withdrawal Scale (COWS) score of 12 or greater
* History of hypersensitivity to ketamine, or experience of emergence reaction
* History of hypersensitivity to ondansetron or concurrently using apomorphine
* History of any illicit or recreational use of ketamine in the past 12 months
* Receipt of ketamine treatment for depression in the past 3 months
* History of DSM5 hallucinogen use disorder, intracranial mass or bleed, porphyria, thyrotoxicosis, seizure disorder other than from alcohol withdrawal, liver cirrhosis, or sleep apnea
* Cardiac or EKG abnormalities based on history, physical examination or the baseline EKG
* History within 6 months of thoracic surgery, lung cancer, head trauma, stroke, or myocardial infarction
* Liver dysfunction with LFTs \>3x upper normal limit
* Current use of medications with known drug-drug interactions with ketamine (i.e., St. John's Wort, theophylline, opioid analgesics other than buprenorphine and methadone for the treatment OUD, Central Nervous System (CNS) depressants other than benzodiazepines or phenobarbital)
* Pregnant
* Patients who are breastfeeding
* ASA class 3 or greater or documented history of difficult airway in HER
* Active exacerbation of COPD or asthma
* Currently participating or anticipated to participate in a concurrent investigational clinical trial
* High risk for adverse emotional or behavioral reaction based on the opinion of the study investigators, including evidence of a personality disorder

Primary outcomes:
measure: Lower Suicidal Ideation
timeFrame: 7-day remote follow up; 14- day remote follow up; 28 days after being discharged from inpatient unit or emergency department.
measure: Less Illicit Opioid Use
timeFrame: 28 days after being discharged from inpatient unit or emergency department.
measure: Incidence of Serious Adverse Events (SAE)
timeFrame: From the beginning on the infusion, every 15 minutes throughout infusion, and at the end of the infusion.
Secondary outcomes:
measure: Opioid Withdrawal
timeFrame: Assessed daily while the participant remains in the ED, starting with the day that the ketamine/placebo infusion occurs until the discharge date.
measure: Days to Relapse
timeFrame: 7-day remote follow up; 14- day remote follow up; 28 days after being discharged from inpatient unit or emergency department.
measure: Percentage of Addiction Treatment Engagement
timeFrame: 28 days after being discharged from inpatient unit or emergency department.
measure: Urine Toxicology Result for Ketamine
timeFrame: 28 days after being discharged from inpatient unit or emergency department.
measure: Urine Toxicology Result for Opioids
timeFrame: 28 days after being discharged from inpatient unit or emergency department.
measure: Emergence of Psychiatric Adverse Effects
timeFrame: 28 days after being discharged from inpatient unit or emergency department.
measure: Emergence of Psychiatric Adverse Effects
timeFrame: 28 days after being discharged from inpatient unit or emergency department.
measure: Craving for Opioids
timeFrame: 7-day remote follow up; 14- day remote follow up; 28 days after being discharged from inpatient unit or emergency department.
measure: Craving for Ketamine
timeFrame: 7-day remote follow up; 14- day remote follow up; 28 days after being discharged from inpatient unit or emergency department.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
References: