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New treatment option for Opioid Use Disorder
Official title Ketamine for Opioid Use Disorder
ClinicalTrials.gov ID: NCT06943859
What this study is testing
What is Treatment with Ketamine?
Treatment with Ketamine is an investigational medicine, given as an once-weekly injection into a muscle, being studied as a potential treatment for opioid use disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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
You likely can't join if
- 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 \ 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)
See the full eligibility 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
- 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 \ 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...
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.