Clinical TrialOpioid Use Disorder (OUD)KetamineRecruiting

Ketamine Assisted Psychotherapy for Opioid Use Disorder

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).

Target Enrollment
60 participants
Study Type
Phase I/II interventional
Design
Randomized, double Blind

Detailed Description

Stage 1 randomised, parallel-group trial comparing MORE combined with two ketamine-assisted psychotherapy sessions (MORE+KAP) versus MORE alone in patients receiving medications for OUD (e.g., buprenorphine).

MORE+KAP participants receive two intramuscular ketamine sessions (0.5–1.5 mg/kg) alongside the 8-week MORE programme; primary outcomes assess preliminary efficacy of KAP as an adjunct to MORE and secondary aims examine psychobiological mediators.

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Therapeutic Protocol

mindfulness

Study Arms & Interventions

MORE+KAP

experimental

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

Interventions

  • Ketamine1.5 mg/kg
    via IM• two sessions• 2 doses total

    0.5–1.5 mg/kg IM across two sessions

MORE

active comparator

8 weeks of Mindfulness-Oriented Recovery Enhancement (behavioral comparator)

Interventions

  • Compound
    via Other• 8 weeks

    Mindfulness-Oriented Recovery Enhancement behavioural intervention; participants remain on MOUD (e.g., buprenorphine)

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 1. Diagnosis of Opioid Use Disorder
  • 2. Receiving OUD treatment with a buprenorphine formulation

Exclusion Criteria

  • 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

Study Details

  • Status
    Recruiting
  • Phase
    Phase IPhase II
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment60 participants
  • Timeline
    Start: 2021-05-20
    End: 2024-05-30
  • Compound
    Ketamine
  • Topic
    Opioid Use Disorder (OUD)

Locations

Center on Mindfulness and Integrative Health Intervention Development — Salt Lake City, Utah, United States

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