TerminatedPhase 2ketamine

Ketamine for OUD and Suicidal Ideation in the ED

Sponsored by Brigham and Women's Hospital

NCT ID
NCT06111339
Target Enrollment
4 participants
Start Date
2024-06-14
Est. Completion
2025-03-31

About This Study

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.

Conditions Studied

Opioid Use DisorderSuicidal Ideation

Interventions

  • Ketamine
  • Saline Solution

Eligibility

Age:18 Years - N/A
Healthy Volunteers:No
View full 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

Study Locations (1)

Brigham and Women's Hospital
Boston, Massachusetts, United States

This trial is not recruiting

This study is currently not accepting new participants.

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Data Source
ClinicalTrials.gov

Last updated from source

Ketamine for OUD and Suicidal Ideation in the ED | Huxley