Ketamine for Opioid Use Disorder

NCT ID: NCT06943859

Last Updated: 2025-11-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2029-08-31

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

Conditions

Opioid Use Disorder

Keywords

opioid use disorder; ketamine; craving; treatment adherence; methadone

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment with Ketamine

Individuals will receive four doses spaced 1-6 days apart of 0.75mg/kg of intramuscular ketamine (n=25) over a period of two weeks.

Group Type: EXPERIMENTAL

Treatment with Ketamine

Intervention Type: DRUG

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.

Treatment with Very Low Dose Ketamine

Individuals will receive four doses spaced 1-6 days apart of an intramuscular ketamine (0.1mg/kg) (n=25) over a period of two weeks.

Group Type: ACTIVE_COMPARATOR

Treatment with Very Low Dose Ketamine

Intervention Type: DRUG

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.

Interventions

Treatment 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.

Intervention Type: DRUG

Treatment 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.

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Peter Manza

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter Manza, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, Baltimore

Locations

University of Maryland Addiction Programs and Affiliated Clinics

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Peter Manza, PhD

Role: CONTACT

Phone: 410-706-2814

Email: peter.manza@som.umaryland.edu

Kynah Walston, MA

Role: CONTACT

Phone: 443-974-7951

Email: Kynah.Walston@som.umaryland.edu

Facility Contacts

Annabelle Belcher, PhD

Role: primary

Other Identifiers

HP-00114026

Identifier Type: -

Identifier Source: org_study_id