Ketamine Assisted Psychotherapy for Opioid Use Disorder

Utah System of Higher Education (USHE)

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Opioid-use Disorder

Treatments: Combination Product: MORE+KAP; Behavioral: MORE

Study type: Interventional

Funder types: Other

Identifiers

NCT04892251

IRB_00130630

Details and patient eligibility

About

This pilot clinical trial aims to assess the preliminary efficacy of ketamine as an adjunct for a mindfulness-based intervention for opioid use disorder.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of Opioid Use Disorder
2. Receiving OUD treatment with a buprenorphine formulation

Exclusion criteria

1. Previous experience with a mindfulness-based intervention program
2. Pregnancy
3. Any serious medical, mental, or cognitive issue that prevents successful participation in a mindfulness-based group treatment program
4. Prior use of ketamine other than as prescribed by a physician
5. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

MORE+KAP

Experimental group

Description:

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

Treatment:

Combination Product: MORE+KAP

MORE

Active Comparator group

Description:

8 weeks of Mindfulness-Oriented Recovery Enhancement

Treatment:

Behavioral: MORE