Center on Mindfulness and Integrative Health Intervention Development
Salt Lake City, Utah, 84112, United States
Location status: Recruiting
NCT Number: NCT04892251
This pilot clinical trial aims to assess the preliminary efficacy of ketamine as an adjunct for a mindfulness-based intervention for opioid use disorder.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1 / Phase 2
Salt Lake City, Utah, 84112, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Mindfulness-Oriented Recovery Enhancement plus two sessions where 0.5 to 1.5 mg/kg of ketamine are administered intramuscularly
Mindfulness-Oriented Recovery Enhancement
Time frame: From baseline to 3-month follow-up
Days of drug use as measured by the Timeline Followback Procedure
Time frame: From baseline to 3-month follow-up
Days of MOUD use as measured by the Timeline Followback Procedure
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Time frame: From baseline to immediately after the 8 week intervention.
Theta oscillations as measured by EEG during meditation
Contact information is provided by the study sponsor or research team.
University of Utah
Other
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.
Published trials that share one or more normalized conditions with this study.
NCT04197921
Chemically-Induced Disorders, Mental Disorders
Tampa, Florida, United States
View Trial DetailsNCT05033028
Chemically-Induced Disorders, Mental Disorders
Piscataway, New Jersey, United States
View Trial DetailsNCT04354077
Behavior, Behavior, Addictive
Pittsburgh, Pennsylvania, United States
View Trial DetailsNCT05011266
Chemically-Induced Disorders, Mental Disorders
Rockville, Maryland, United States
View Trial Details