Clinical trial NCT04892251: Ketamine Assisted Psychotherapy for Opioid Use Disorder
Official title: Ketamine Assisted Psychotherapy for Opioid Use Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Opioid-use Disorder
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2021-05-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of Opioid Use Disorder
2. Receiving OUD treatment with a buprenorphine formulation

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

Primary outcomes:
measure: Drug use
timeFrame: From baseline to 3-month follow-up
Secondary outcomes:
measure: MOUD use
timeFrame: From baseline to 3-month follow-up
measure: Emotional Distress
timeFrame: From baseline to 3-month follow-up
measure: Meaning in life
timeFrame: From baseline to 3-month follow-up
measure: Opioid craving
timeFrame: From baseline to 3-month follow-up
measure: Self-transcendence
timeFrame: From baseline to 3-month follow-up
measure: Affect
timeFrame: From baseline to 1-month follow-up
measure: Mindfulness
timeFrame: From baseline to 3-month follow-up
measure: Reappraisal
timeFrame: From baseline to 3-month follow-up
measure: Savoring
timeFrame: From baseline to 3-month follow-up
measure: Momentary craving
timeFrame: From baseline to 1-month follow-up
Other outcomes:
measure: Drug cue-reactivity
timeFrame: From baseline to immediately after the 8 week intervention.
measure: Emotion regulation
timeFrame: From baseline to immediately after the 8 week intervention.
measure: Theta oscillations
timeFrame: From baseline to immediately after the 8 week intervention.
Locations:
city: Salt Lake City
country: United States
facility: Center on Mindfulness and Integrative Health Intervention Development
state: Utah
Study officials:
affiliation: University of Utah
name: Eric L Garland
role: PRINCIPAL_INVESTIGATOR
References: