Ketamine for Opioid Use Disorder

This randomised, quadruple-blind, placebo-controlled Phase II trial (n=50) will assess the effects of ketamine (52.5mg/70kg, intramuscularly, four times over two weeks) on opioid craving and withdrawal symptoms in adults newly entering methadone treatment for opioid use disorder.

Led by Dr Peter Manza and conducted at the University of Maryland Addiction Programs in Baltimore, this study aims to determine whether ketamine can reduce opioid cravings, alleviate symptoms such as depression and poor sleep, and improve overall treatment outcomes, including retention in methadone therapy.

Participants will receive either ketamine or an active placebo (diphenhydramine 50 mg) on four occasions spaced 1–6 days apart. Follow-up visits and assessments will continue for 90 days post-intake, evaluating craving intensity, depression severity, cue-induced craving, pain, sleep quality, methadone adherence, and broader measures of substance use recovery. This research explores whether ketamine can be a supportive treatment during the critical early stages of opioid use recovery.

Trial Details

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 ketamine stay in methadone treatment longer, and/or have better treatment outcomes than those given the placebo? Researchers will compare ketamine to an active placebo (a look-alike substance that contains a drug that does not do anything to help the condition it is supposed to treat but will mimic some of the side effects 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 ketamine or a placebo 4 times over a period of 2 weeks - Visit the clinic weekly and monthly for checkups and tests for 90 days post-intake

Trial Number NCT06943859

Data attribution

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