NCT04892251

Ketamine Assisted Psychotherapy for Opioid Use Disorder

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Opioid-use Disorder

Interventions

Type	Name	Description
COMBINATION_PRODUCT	MORE+KAP	Mindfulness-Oriented Recovery Enhancement plus two sessions where 0.5 to 1.5 mg/kg of ketamine are administered intramuscularly
BEHAVIORAL	MORE	Mindfulness-Oriented Recovery Enhancement

Timeline

• Start date: 2021-05-20
• Primary completion: 2023-12-30
• Completion: 2024-05-30
• First posted: 2021-05-19
• Last updated: 2023-07-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study