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NCT Number: NCT04892251

Ketamine Assisted Psychotherapy for Opioid Use Disorder

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Center on Mindfulness and Integrative Health Intervention Development

Salt Lake City, Utah, 84112, United States

Location status: Recruiting

Location contact

Research Coordinator

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MORE+KAP

Combination Product

Mindfulness-Oriented Recovery Enhancement plus two sessions where 0.5 to 1.5 mg/kg of ketamine are administered intramuscularly

MORE

Behavioral

Mindfulness-Oriented Recovery Enhancement

Primary outcomes

  1. Drug use

    Time frame: From baseline to 3-month follow-up

    Days of drug use as measured by the Timeline Followback Procedure

Secondary outcomes

  1. MOUD use

    Time frame: From baseline to 3-month follow-up

    Days of MOUD use as measured by the Timeline Followback Procedure

  2. Emotional Distress

    Time frame: From baseline to 3-month follow-up

    Emotional distress measured by the Depression Anxiety Stress Scale, range from 0 to 63, higher scores indicating worse distress.

  3. Meaning in life

    Time frame: From baseline to 3-month follow-up

    Meaning in life measured by the Meaning in Life Questionnaire, Presence Subscale, range from 5 to 35, higher scores indicating more meaning in life.

  4. Opioid craving

    Time frame: From baseline to 3-month follow-up

    Craving measured by the Desires for Drug Questionnaire, range from 13 to 91, higher scores indicating higher craving.

  5. Self-transcendence

    Time frame: From baseline to 3-month follow-up

    Self-transcendence measured by the Nondual Awareness Dimensional Assessment, range from 13 to 65, higher scores indicating greater self-transcendence.

  6. Affect

    Time frame: From baseline to 1-month follow-up

    Affect measured by Ecological Momentary Assessment, range from 0-10, higher scores indicating more intense affective states.

  7. Mindfulness

    Time frame: From baseline to 3-month follow-up

    Mindfulness measured by the Five Facet Mindfulness Questionnaire, range from 39 to 195, higher scores indicating greater mindfulness.

  8. Reappraisal

    Time frame: From baseline to 3-month follow-up

    Reappraisal measured by the Cognitive Emotion Regulation Questionnaire, range from 4 to 20, higher scores indicating more frequent use of reappraisal.

  9. Savoring

    Time frame: From baseline to 3-month follow-up

    Savoring measured by the Brief Savoring Inventory, range from 4 to 20, higher scores indicating more use of savoring.

  10. Momentary craving

    Time frame: From baseline to 1-month follow-up

    Affect measured by Ecological Momentary Assessment, range from 0-10, higher scores indicating more intense momentary craving.

Other outcomes

  1. Drug cue-reactivity

    Time frame: From baseline to immediately after the 8 week intervention.

    Change from baseline in neurophysiological response during lab-based task involving presentation of drug cues designed to measure cue-reactivity.

  2. Emotion regulation

    Time frame: From baseline to immediately after the 8 week intervention.

    Change from baseline in neurophysiological response during lab-based task involving presentation of emotional stimuli.

  3. Theta oscillations

    Time frame: From baseline to immediately after the 8 week intervention.

    Theta oscillations as measured by EEG during meditation

Study contacts

Contact information is provided by the study sponsor or research team.

Research Coordinator

CONTACT

[email protected]

801-581-3826

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
May 19, 2021
Registry last updated
Jul 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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