Overview
This pilot clinical trial aims to assess the preliminary efficacy of ketamine as an adjunct for a mindfulness-based intervention for opioid use disorder.
Description
The purpose of this study is to conduct a Stage 1 randomized controlled trial to test a potential optimization of the evidence-based Mindfulness-Oriented Recovery Enhancement (MORE) intervention for opioid use disorder (OUD). Here we will add Ketamine to MORE (MORE+KAP) and test the MORE+KAP intervention versus the standard MORE intervention in a sample of patients receiving medications for OUD (MOUD; e.g, buprenorphine). The primary aim to is evaluate the extent to which MORE+KAP improves OUD treatment relative to MORE. The secondary aim is to identify the psychobiological mediators of MORE+KAP.
Eligibility
Inclusion Criteria:
- Diagnosis of Opioid Use Disorder
- Receiving OUD treatment with a buprenorphine formulation
Exclusion Criteria:
- Previous experience with a mindfulness-based intervention program
- Pregnancy
- Any serious medical, mental, or cognitive issue that prevents successful participation in a mindfulness-based group treatment program
- Prior use of ketamine other than as prescribed by a physician
- Any of the following medical conditions
Blood Vessel Disease Heart Valve Disease Heart Failure Class 2 or Above Heart Disease
Pregnancy/Breastfeeding Arteriovenous Malformation History of Intracranial Bleeding or
Stroke History of Seizures Hypoxia defined by current need for supplemental oxygen Liver
Disease History of allergic reaction to Ketamine Dementia (moderate-severe) History of
Psychotic Disorder, Bipolar Disorder, or Personality Disorder Dissociative Identity
Disorder