Opioid-use DisorderPhase 1/2NCT04892251
Ketamine Assisted Psychotherapy for Opioid Use Disorder
A Phase 1/2 study testing MORE+KAP and MORE in people with Opioid-use Disorder, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid-use Disorder
- What is being tested?
- MORE+KAP and MORE
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2021to 30 May 2024
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Opioid Use Disorder
- Receiving OUD treatment with a buprenorphine formulation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Center on Mindfulness and Integrative Health Intervention Development
Salt Lake City, Utah, 84112
Research Coordinator, KetaMORE@utah.edu
About this study
This pilot clinical trial aims to assess the preliminary efficacy of ketamine as an adjunct for a mindfulness-based intervention for opioid use disorder.
Read the 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.
- Conditions
- Opioid-use Disorder
- Being tested
- MORE+KAP, MORE
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MORE+KAPCombination product
Mindfulness-Oriented Recovery Enhancement plus two sessions where 0.5 to 1.5 mg/kg of ketamine are administered intramuscularly
MOREBehavioural
Mindfulness-Oriented Recovery Enhancement
| Study group | Role | What they receive |
|---|---|---|
| MORE+KAP | Experimental | 8 weeks of Mindfulness-Oriented Recovery Enhancement plus two ketamine assisted psychotherapy sessions Receives: Combination Product: MORE+KAP |
| MORE | Active comparator | 8 weeks of Mindfulness-Oriented Recovery Enhancement Receives: Behavioral: MORE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug use
Days of drug use as measured by the Timeline Followback Procedure
Measured: From baseline to 3-month follow-up
Secondary outcomes (10)
MOUD use
Days of MOUD use as measured by the Timeline Followback Procedure
Measured: From baseline to 3-month follow-up
Emotional Distress
Emotional distress measured by the Depression Anxiety Stress Scale, range from 0 to 63, higher scores indicating worse distress.
Measured: From baseline to 3-month follow-up
Meaning in life
Meaning in life measured by the Meaning in Life Questionnaire, Presence Subscale, range from 5 to 35, higher scores indicating more meaning in life.
Measured: From baseline to 3-month follow-up
Opioid craving
Craving measured by the Desires for Drug Questionnaire, range from 13 to 91, higher scores indicating higher craving.
Measured: From baseline to 3-month follow-up
Self-transcendence
Self-transcendence measured by the Nondual Awareness Dimensional Assessment, range from 13 to 65, higher scores indicating greater self-transcendence.
Measured: From baseline to 3-month follow-up
Affect
Affect measured by Ecological Momentary Assessment, range from 0-10, higher scores indicating more intense affective states.
Measured: From baseline to 1-month follow-up
Mindfulness
Mindfulness measured by the Five Facet Mindfulness Questionnaire, range from 39 to 195, higher scores indicating greater mindfulness.
Measured: From baseline to 3-month follow-up
Reappraisal
Reappraisal measured by the Cognitive Emotion Regulation Questionnaire, range from 4 to 20, higher scores indicating more frequent use of reappraisal.
Measured: From baseline to 3-month follow-up
Savoring
Savoring measured by the Brief Savoring Inventory, range from 4 to 20, higher scores indicating more use of savoring.
Measured: From baseline to 3-month follow-up
Momentary craving
Affect measured by Ecological Momentary Assessment, range from 0-10, higher scores indicating more intense momentary craving.
Measured: From baseline to 1-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start20 May 2021
- Primary completion30 Dec 2023 (estimated)
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Garland, University of Utah
- Investigators
- Eric L Garland, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04892251
- Sponsor's protocol ID
- IRB_00130630
- Status last verified
- Jul 2023
- First submitted
- 10 May 2021
- Last updated
- 5 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketamine Assisted Psychotherapy for Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT04892251
- Acronym / sponsor ID
- IRB_00130630
- Conditions
- Opioid-use Disorder
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 20 May 2021 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 19 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MORE+KAP | Experimental | Combination Product: MORE+KAP8 weeks of Mindfulness-Oriented Recovery Enhancement plus two ketamine assisted psychotherapy sessions |
| MORE | Active comparator | Behavioral: MORE8 weeks of Mindfulness-Oriented Recovery Enhancement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of Opioid Use Disorder
- Receiving OUD treatment with a buprenorphine formulation
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MORE+KAPMindfulness-Oriented Recovery Enhancement plus two sessions where 0.5 to 1.5 mg/kg of ketamine are administered intramuscularly | Combination product | MORE+KAP |
| MOREMindfulness-Oriented Recovery Enhancement | Behavioural | MORE |
Primary outcome
Drug use
Time frame: From baseline to 3-month follow-up
Days of drug use as measured by the Timeline Followback Procedure
10 secondary outcomes
MOUD use
Time frame: From baseline to 3-month follow-up
Emotional Distress
Time frame: From baseline to 3-month follow-up
Meaning in life
Time frame: From baseline to 3-month follow-up
Opioid craving
Time frame: From baseline to 3-month follow-up
Self-transcendence
Time frame: From baseline to 3-month follow-up
Affect
Time frame: From baseline to 1-month follow-up
Mindfulness
Time frame: From baseline to 3-month follow-up
Reappraisal
Time frame: From baseline to 3-month follow-up
Savoring
Time frame: From baseline to 3-month follow-up
Momentary craving
Time frame: From baseline to 1-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eric L Garland principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MORE+KAP and MORE in people with Opioid-use Disorder, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Research Coordinator (801-581-3826, eric.garland@socwk.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drug use (time frame: From baseline to 3-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2023.