Ketamine for the Treatment of Opioid Use Disorder

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
United States
Maryland
University of Maryland Addiction Programs and Affiliated Clinics
RECRUITING
Baltimore
Contact Information
Primary
Peter Manza, PhD
peter.manza@som.umaryland.edu
410-706-2814
Backup
Kynah Walston, MA
Kynah.Walston@som.umaryland.edu
443-974-7951
Time Frame
Start Date: 2025-12
Estimated Completion Date: 2029-08-31
Participants
Target number of participants: 50
Treatments
Experimental: 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.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: University of Maryland, Baltimore

This content was sourced from clinicaltrials.gov

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