This Phase I/Phase II interventional trial (n=60) aims to evaluate Ketamine Assisted Psychotherapy (KAP) as an adjunct to the Mindfulness-Oriented Recovery Enhancement (MORE) intervention for Opioid Use Disorder (OUD).
Led by the University of Utah, the study investigates the preliminary efficacy of combining ketamine with MORE compared to standard MORE alone in individuals receiving medications for OUD, such as buprenorphine.
The primary objective is to assess whether MORE+KAP improves OUD treatment outcomes relative to MORE alone. Secondary aims include identifying the psychobiological mediators of MORE+KAP. Participants aged 18 and above diagnosed with OUD and receiving buprenorphine treatment are eligible.
Exclusion criteria include previous experience with mindfulness-based interventions, pregnancy, serious medical, mental, or cognitive issues hindering participation, and prior non-prescribed ketamine use.
The study involves parallel assignment with random allocation and double masking. The experimental arm receives 8 weeks of MORE plus two ketamine sessions, while the control arm receives only MORE.
Outcome measures include drug use, days of MOUD use, emotional distress, meaning in life, opioid craving, self-transcendence, affect, mindfulness, reappraisal, savoring, momentary craving, drug cue-reactivity, emotion regulation, and theta oscillations.
The study started on May 20, 2021, with an estimated primary completion date of December 30, 2023, and completion date of May 30, 2024. Recruitment is ongoing in Salt Lake City, Utah, United States.
Trial Details
This pilot clinical trial aims to assess the preliminary efficacy of ketamine as an adjunct for a mindfulness-based intervention for opioid use disorder.NCT Number NCT04892251
Sponsors & Collaborators
University of UtahResearch with psychedelics is underway at the University of Utah. At the university, researchers are working with the Usona Institute exploring psilocybin-assisted group therapy in patients with cancer.