NCT06943859 · University of Maryland, Baltimore
Ketamine for Opioid Use Disorder
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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)
- NOTE: Due to time constraints in the study design, these exclusion criteria do not need to be met before the initial consent to participate. This criterion only needs to be established prior to the first ketamine session. Individuals that are initially enrolled and subsequently do not qualify due to severe hepatic impairment will be considered screen failures and withdrawn from the protocol.
Where
- Baltimore, Maryland
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 13, 2026 · Source of record for eligibility and locations