RecruitingPhase 2NCT06943859

Ketamine for Opioid Use Disorder

Ketamine for the Treatment of Opioid Use Disorder

Sponsor

University of Maryland, Baltimore

Enrollment

50 participants

Start Date

Feb 4, 2026

Study Type

INTERVENTIONAL

Conditions

Opioid-use Disorder

Summary

The goal of this clinical trial is to learn if ketamine works to reduce craving for opioids in adults entering methadone treatment for opioid use disorder. The main questions it aims to answer are: * Does ketamine reduce craving for opioids in patients with opioid use disorder? * Does ketamine reduce symptoms of opioid withdrawal such as depression, pain, and poor sleep quality? * Do patients who take the low dose ketamine stay in methadone treatment longer, and/or have better treatment outcomes than those given the very low dose? Researchers will compare two low doses of ketamine to see if ketamine works to reduce craving for opioids in adults entering methadone treatment for opioid use disorder. Participants will: * Be given a low dose or a very low dose of ketamine 4 times over a period of 2 weeks * Visit the clinic weekly and monthly for checkups and tests for 90 days post-intake

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria5

Age 18 to 65 years old
Recent history (most recent 2 weeks prior to clinic intake) of routine use of illicit opioids, 5+ times/week
Fulfillment of DSM-5/ICD-10 criteria for moderate-to-severe opioid use disorder
Acceptance into methadone treatment for opioid use disorder within the past 21 days at the time of screening
Adherence to lifestyle requirements for participation

Exclusion Criteria15

Routine use of prescribed medications for OUD (5+ days/week) for longer than the 14 days leading up to clinic intake
Pregnant and/or breastfeeding
**Stage 2 Hypertension, defined by a systolic blood pressure (SBP) > 140mmHg or a diastolic blood pressure (DBP) > 90 mmHg
Abnormal oxygen saturation or abnormal heart rate (i.e. O2 saturation <95%, or HR <60 or >100bpm)
Clinically significant abnormal findings for which study participation is deemed unsafe
Severe mental illness or psychiatric disorder for which study participation is deemed unsafe (except for depression, PTSD, and substance use disorder)
**ALT/AST > 3 x Upper Limit of Normal (ULN), ALP 2 x ULN, or total bilirubin > 1.5 x ULN. Source: Labs
History of hypersensitivity to ketamine
Suicidal ideation with a plan or intent or suicidal behaviors as reflected in Columbia-Suicide Severity Rating Scale (C-SSRS)
Recent homicidal ideation or violent behaviors
Concomitant daily use of medications with significant CYP2B6 and CYP3A4 inhibition or induction effects that can interfere with metabolism of ketamine
Advanced cardiopulmonary disorders, including stroke, cardiac arrest, and myocardial infarction in the past year
History of aneurysmal vascular disease or dissection (including thoracic and abdominal aorta, intracranial, and peripheral arterial vessels) or arteriovenous malformation
**Clinically significant EKG abnormalities.
Current significant use (>3 days/week) of barbiturates, sedative hypnotics, benzodiazepines, ketamine, or PCP (prescribed or illicit)

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Interventions

DRUGTreatment with Ketamine

Participants will receive four doses of ketamine spaced 1-6 days apart of 0.75 mg/kg intramuscular ketamine (n=25) for two weeks (first ketamine session must occur no later than 28 days post-intake). Individuals will be monitored for two hours post-dose by a clinician.

DRUGTreatment with Very Low Dose Ketamine

Participants will receive four doses of very low dose ketamine (0.1mg.kg) (n=25) spaced 1-6 days apart for two weeks (first ketamine session must occur no later than 28 days post-intake). Individuals will be monitored for two hours post-dose by a clinician.