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Ketamine for Opioid Use Disorder and Suicidal Thoughts

Phase 2

Recruiting

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

English speaking adults aged 18 and above

Be older than 18 years old

Must not have

Cardiac or EKG abnormalities based on history, physical examination or the baseline EKG

Inability to perform consent due to impaired mental status, including substance intoxication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 days after being discharged from inpatient unit or emergency department.

Awards & highlights

Summary

This trial is testing the safety and effectiveness of using ketamine in treating individuals with opioid use disorder and suicidal thoughts. Participants will receive either ketamine or a placebo, and the study aims to see if

Who is the study for?

This trial is for English-speaking adults over 18 with moderate to severe opioid use disorder (OUD) who have had an overdose before and are currently having suicidal thoughts serious enough for psychiatric hospitalization. They must be medically cleared and able to understand the research study consent process.

What is being tested?

The trial tests if a single ketamine infusion (0.8mg/kg) is safe and effective compared to a saline placebo in reducing opioid use and suicidal thoughts among OUD patients in the emergency department. It's double-blind, meaning neither doctors nor participants know who gets ketamine or placebo.

What are the potential side effects?

While not specified here, common side effects of ketamine may include confusion, hallucinations, changes in blood pressure, nausea, dizziness, blurred vision, and feelings of detachment from reality.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 or older and speak English.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have heart or EKG issues.

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I am mentally capable of understanding and giving consent for treatment.

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I am allergic to ondansetron or using apomorphine.

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My liver tests are more than three times the normal limit.

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I have not had thoracic surgery, lung cancer treatment, head trauma, stroke, or a heart attack in the last 6 months.

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I am not taking medications like St. John's Wort or opioids (except buprenorphine and methadone).

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My blood pressure or heart rate is higher than normal when checked in the emergency department.

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I have never had hallucinogen use disorder, brain issues, porphyria, thyroid problems, seizures (not from alcohol), liver cirrhosis, lung disease, or sleep apnea.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7-day remote follow up; 14- day remote follow up; 28 days after being discharged from inpatient unit or emergency department.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7-day remote follow up; 14- day remote follow up; 28 days after being discharged from inpatient unit or emergency department.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7-day remote follow up; 14- day remote follow up; 28 days after being discharged from inpatient unit or emergency department. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Serious Adverse Events (SAE)

Less Illicit Opioid Use

Lower Suicidal Ideation

Secondary study objectives

Craving for Ketamine

Craving for Opioids

Days to Relapse

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: KetamineExperimental Treatment1 Intervention

This arm will receive ketamine (n=25)

Group II: Saline PlaceboPlacebo Group1 Intervention

This arm will receive the saline placebo (n=25)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ketamine

2011

Completed Phase 4

~1120

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor

1,653 Previous Clinical Trials

11,490,985 Total Patients Enrolled

~28 spots leftby Mar 2025

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