NCT06943859 Ketamine for Opioid Use Disorder
| NCT ID | NCT06943859 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Maryland, Baltimore |
| Condition | Opioid Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-02-04 |
| Primary Completion | 2028-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 50 participants in total. It began in 2026-02-04 with a primary completion date of 2028-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Age 18 to 65 years old 2. Recent history (most recent 2 weeks prior to clinic intake) of routine use of illicit opioids, 5+ times/week 3. Fulfillment of DSM-5/ICD-10 criteria for moderate-to-severe opioid use disorder 4. Acceptance into methadone treatment for opioid use disorder within the past 21 days at the time of screening 5. Adherence to lifestyle requirements for participation Exclusion Criteria: 1. Routine use of prescribed medications for OUD (5+ days/week) for longer than the 14 days leading up to clinic intake 2. Pregnant and/or breastfeeding 3. \*\*Stage 2 Hypertension, defined by a systolic blood pressure (SBP) \> 140mmHg or a diastolic blood pressure (DBP) \> 90 mmHg 4. Abnormal oxygen saturation or abnormal heart rate (i.e. O2 saturation \<95%, or HR \<60 or \>100bpm) 5. Clinically significant abnormal findings for which study participation is deemed unsafe 6. Severe mental illness or psychiatric disorder for which study participation is deemed unsafe (except for depression, PTSD, and substance use disorder) 7. \*\*ALT/AST \> 3 x Upper Limit of Normal (ULN), ALP 2 x ULN, or total bilirubin \> 1.5 x ULN. Source: Labs 8. History of hypersensitivity to ketamine 9. Suicidal ideation with a plan or intent or suicidal behaviors as reflected in Columbia-Suicide Severity Rating Scale (C-SSRS) 10. Recent homicidal ideation or violent behaviors 11. Concomitant daily use of medications with significant CYP2B6 and CYP3A4 inhibition or induction effects that can interfere with metabolism of ketamine 12. Advanced cardiopulmonary disorders, including stroke, cardiac arrest, and myocardial infarction in the past year 13. History of aneurysmal vascular disease or dissection (including thoracic and abdominal aorta, intracranial, and peripheral arterial vessels) or arteriovenous malformation 14. \*\*Clinically significant EKG abnormalities. 15. 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.
Contact & Investigator
Peter Manza, PhD
PRINCIPAL INVESTIGATOR
University of Maryland, Baltimore
Frequently Asked Questions
Who can join the NCT06943859 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Opioid Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06943859 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06943859 currently recruiting?
Yes, NCT06943859 is actively recruiting participants. Contact the research team at peter.manza@som.umaryland.edu for enrollment information.
Where is the NCT06943859 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT06943859 clinical trial?
NCT06943859 is sponsored by University of Maryland, Baltimore. The principal investigator is Peter Manza, PhD at University of Maryland, Baltimore. The trial plans to enroll 50 participants.