Ketamine + Mindfulness Therapy for Opioid Use Disorder

This trial explores a new approach to help individuals with opioid use disorder by combining mindfulness therapy with ketamine-assisted psychotherapy. The main goal is to determine if adding mindfulness techniques can reduce opioid cravings and use more effectively than standard support groups. Participants will receive either the mindfulness-enhanced therapy or the standard therapy with a support group. This trial may suit those diagnosed with opioid use disorder who are currently using buprenorphine as part of their treatment. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

The trial does not specify if you need to stop taking your current medications, but you must be on a buprenorphine-containing product. If you are taking certain medications like monoamine oxidase inhibitors or CYP2B6 inhibitors/inducers, you may not be eligible to participate.

Research has shown that ketamine has been studied for various mental health and substance use issues, including opioid use disorder (OUD). Evidence suggests that ketamine may help those who haven't responded to other treatments. Known for its rapid antidepressant effects, ketamine can be beneficial for OUD.

Studies have found that patients generally tolerate ketamine well. Some may experience mild side effects like dizziness or nausea, while serious side effects are rare but possible. Discussing these potential effects with the trial team is important.

Mindfulness-Oriented Recovery Enhancement (MORE) uses mindfulness and cognitive strategies. Although specific studies on MORE's safety are limited, mindfulness practices are generally considered safe for most people.

Researchers are excited about Ketamine-Assisted Psychotherapy combined with Mindfulness-Oriented Recovery Enhancement (KetaMORE) for opioid use disorder because it offers a unique approach by integrating mindfulness techniques with ketamine treatment. Unlike standard options like methadone or buprenorphine that primarily focus on reducing withdrawal symptoms and cravings through opioid receptor modulation, KetaMORE targets craving and emotional regulation through mindfulness and cognitive reappraisal. This approach promises to not only manage physical dependence but also address the psychological aspects of addiction, potentially leading to more comprehensive and sustained recovery. Additionally, the use of ketamine, known for its rapid effects on mood and craving, adds an innovative layer to the treatment, offering hope for quicker and possibly more profound results.

Research has shown that Mindfulness-Oriented Recovery Enhancement (MORE) can help reduce cravings for opioids in people with opioid use disorder (OUD). One study found that MORE effectively lowered opioid misuse among adults with chronic pain. This therapy boosts positive feelings and changes how the brain reacts to cravings. Ketamine, a drug commonly used in anesthesia, has shown potential for treating OUD because it can quickly improve mood. In this trial, participants will be assigned to different treatment arms: one will receive ketamine-assisted psychotherapy combined with MORE, while another will receive ketamine-assisted psychotherapy combined with a support group. Together, these treatments might offer a unique way to combine the benefits of mindfulness and ketamine to help reduce opioid use and cravings.¹⁴⁶⁷⁸