What side effects are associated with this type of intervention?

Common treatments for Opioid Use Disorder include medications like methadone, buprenorphine, and naltrexone. Methadone and buprenorphine can cause side effects such as constipation, sweating, sexual dysfunction, and potential for misuse. Naltrexone may lead to nausea, headache, dizziness, and liver enzyme abnormalities. Ketamine, which is being studied for OUD, can cause side effects including vivid dreams, hallucinations, hypertension, and dissociation. These side effects are important to consider when evaluating treatment options with a healthcare provider.

What prior FDA approvals exist?

FDA-approved treatments for Opioid Use Disorder primarily include medications such as methadone, buprenorphine, and naltrexone. Methadone is a full opioid agonist, buprenorphine is a partial opioid agonist, and naltrexone is an opioid antagonist. These medications work by targeting opioid receptors to reduce cravings and withdrawal symptoms. Unlike these treatments, ketamine, which is being studied for OUD, modulates glutamate neurotransmission and promotes neuroplasticity, offering a different mechanism of action that may provide new therapeutic benefits.

What other types of research exist?

Promising alternatives to ketamine for opioid use disorder include methadone and ketobemidone, which are non-competitive NMDA antagonists. These agents not only act as opioid agonists but also inhibit NMDA receptor activity, potentially offering dual benefits in managing opioid dependence and withdrawal symptoms.

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Ketamine Assisted Psychotherapy for Opioid Use Disorder

Phase 1 & 2

Recruiting

Led By Eric L Garland

Research Sponsored by University of Utah

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Receiving OUD treatment with a buprenorphine formulation

Be older than 18 years old

Must not have

Heart Valve Disease

Arteriovenous Malformation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to 3-month follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether adding ketamine to a mindfulness program can help people recovering from opioid addiction. The study focuses on patients who are already taking medication for their addiction. Ketamine might help by reducing cravings and improving mood, while mindfulness exercises teach better management of thoughts and emotions. Currently, ketamine is used in treating multiple pain, mental health, and substance abuse disorders due to its rapid-acting effects.

Who is the study for?

This trial is for individuals currently treated with buprenorphine for opioid use disorder. Participants must not be pregnant or breastfeeding, have severe heart conditions, seizures, need oxygen support, significant liver disease, history of stroke or intracranial bleeding, certain psychiatric disorders like dissociative identity disorder or psychosis, and no prior allergic reactions to ketamine.

What is being tested?

The study is testing the effectiveness of Ketamine Assisted Psychotherapy (KAP) combined with a mindfulness-based intervention called MORE against just the mindfulness program alone in treating opioid addiction.

What are the potential side effects?

Potential side effects may include disorientation or confusion during ketamine administration, elevated blood pressure and heart rate changes. There might also be temporary mood alterations and rare allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am currently being treated for opioid use disorder with a buprenorphine-based medication.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have heart valve disease.

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I have an arteriovenous malformation.

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I currently need extra oxygen.

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I have a history of seizures.

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I have a disease affecting my blood vessels.

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My heart condition limits my physical activity.

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I have only used ketamine if it was prescribed by my doctor.

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I have heart disease.

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I have had a stroke or bleeding in my brain before.

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I have moderate to severe dementia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to 3-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to 3-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 3-month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Drug use

Secondary study objectives

Affect

Emotional Distress

MOUD use

+7 more

Other study objectives

Drug cue-reactivity

Emotion regulation

Theta oscillations

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: MORE+KAPExperimental Treatment1 Intervention

8 weeks of Mindfulness-Oriented Recovery Enhancement plus two ketamine assisted psychotherapy sessions

Group II: MOREActive Control1 Intervention

8 weeks of Mindfulness-Oriented Recovery Enhancement

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Opioid Use Disorder (OUD) include medications like methadone, buprenorphine, and naltrexone. Methadone is a full opioid agonist that reduces withdrawal symptoms and cravings by activating opioid receptors in the brain. Buprenorphine is a partial opioid agonist that also alleviates withdrawal symptoms and cravings but with a ceiling effect that reduces the risk of misuse. Naltrexone is an opioid antagonist that blocks the effects of opioids, preventing the euphoric and sedative effects. These treatments are crucial as they help stabilize brain chemistry, reduce illicit opioid use, and support recovery. Similar to ketamine, which modulates glutamate neurotransmission and promotes neuroplasticity, these medications work by altering neurochemical pathways to restore balance and improve brain function in OUD patients.

Further evidence for a role of NMDA receptors in the locus coeruleus in the expression of withdrawal syndrome from opioids.