Could a low dose of ketamine curb opioid cravings?
NCT ID NCT06943859
First seen Jun 27, 2026 · Last updated Sep 01, 2026 · Updated 2 times
Summary
This study tests whether low-dose ketamine can reduce cravings and withdrawal symptoms in adults starting methadone treatment for opioid use disorder. Fifty participants will receive either a low or very low dose of ketamine four times over two weeks. Researchers will track cravings, depression, pain, and sleep quality for 90 days.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ketamine (low dose)
- What this could lead to
- If it works, this could point toward a way to reduce opioid cravings and help people stay in treatment longer.
- What could go wrong
- This is a small, early-phase trial with only 50 participants. The very low dose group acts as a comparison, so the benefit may be small or not last. Ketamine can cause side effects like dizziness or dissociation.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Aug 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria 1. Age 18 to 65 years old 2. Fulfillment of DSM-5/ICD-10 criteria for moderate-to-severe opioid use disorder 3. Acceptance into methadone treatment for opioid use disorder at the time of screening. 4. Adherence to lifestyle requirements for participation. 5. Self-reported craving greater than or equal to 20 out of 100 for opioids at any point in the past week at time of screening 6. Positive UDS for opioids or self-reported illicit opioid use in the past three months at time of screening Exclusion Criteria 1. Pregnant and/or breastfeeding. 2. \*\*Stage 2 Hypertension, defined by a systolic blood pressure (SBP) \> 140 mmHg or a diastolic blood pressure (DBP) \> 90 mmHg. 3. Abnormal oxygen saturation or abnormal heart rate (i.e. O2 saturation \<95%, or HR \<60 or \>100bpm 4. Clinically significant abnormal findings for which study participation is deemed unsafe. 5. Severe mental illness or psychiatric disorder for which study participation is deemed unsafe (except for depression, PTSD, and substance use disorder). 6. \*\*ALT/AST \> 3 x Upper Limit of Normal (ULN), ALP 2 x ULN, or total bilirubin \> 1.5 x ULN. 7. History of hypersensitivity to ketamine. 8. Suicidal ideation with a plan or intent or suicidal behaviors as reflected in Columbia-Suicide Severity Rating Scale (C-SSRS). 9. Recent homicidal ideation or violent behaviors. 10. Concomitant daily use of medications with significant CYP2B6 and CYP3A4 inhibition or induction effects that can interfere with metabolism of ketamine. 11. Advanced cardiopulmonary disorders, including stroke, cardiac arrest, and myocardial infarction in the past year 12. History of aneurysmal vascular disease or dissection (including thoracic and abdominal aorta, intracranial, and peripheral arterial vessels) or arteriovenous malformation. 13. \*\*Clinically significant EKG abnormalities. 14. 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. This will allow us to enroll participants as soon as possible, giving more time and flexibility to complete the baseline assessments before 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. Because repeated ketamine administration is associated with hepatobiliary dysfunction (most often a cholestatic pattern) we will also obtain a follow up LFT within 30 days of the final ketamine session.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Maryland Addiction Programs and Affiliated Clinics
RECRUITINGBaltimore, Maryland, 21201, United States
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