Opioid Use DisorderNCT06857968
Mobile Mindfulness Training (mMT) for People in Medication Treatment of Opioid Use Disorder (MOUD)
A study testing Mobile Mindfulness Training in people with Opioid Use Disorder, run by Amy Meadows at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if mobile mindfulness training can help people in treatment for opioid use disorder. The main questions it aims to answer are: Will people with opioid use disorder and childhood trauma use mobile mindfulness training? Will mobile mindfulness training help people with opioid… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Mobile Mindfulness Training
- Type of treatment
- 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
- 29 Jul 2025to Jan 2029
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically diagnosed with Opioid Use Disorder (per DSM5 criteria)
- Currently enrolled in treatment for Opioid Use Disorder at a clinic affiliated with UKHealthCare or University of Kentucky
- On a stable dose of buprenorphine, buprenorphine/naloxone, or naloxone (i.e., at least 30 days post-induction and on a stable dose for 30 days)
- Able to read and understand English
- Have a history of childhood trauma as measured by the Adverse Childhood Experiences scale and/or Childhood Trauma Questionnaire.
Who cannot join
- Currently taking a beta-blocker, calcium-channel blocker, antiarrhythmic, corticosteroid, or immune modulator medication
- Uncontrolled acute or chronic health conditions (e.g., active infections, autoimmune conditions, cancer undergoing active treatment)
- Current or expected pregnancy
- Current mindfulness practice (i.e., participant reports practicing mindfulness for 10 minutes or more per week)
- Primary psychotic illness
- Diagnosis of a disorder known to interfere with neurocognitive function (e.g., estimated full scale IQ below 70 or diagnosis of dementia)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Improving Opioid Use Disorder Treatment Engagement Using Mobile Mindfulness in Childhood Trauma Survivors
The goal of this clinical trial is to learn if mobile mindfulness training can help people in treatment for opioid use disorder. The main questions it aims to answer are:
- Will people with opioid use disorder and childhood trauma use mobile mindfulness training?
- Will mobile mindfulness training help people with opioid use disorder and childhood trauma have decreased markers of psychological stress?
Participants will:
Be given access to mobile mindfulness training and encouragement to use it daily for 30 days.
Keep a diary of how often mobile mindfulness training is used. Visit the clinic four times to measure stress levels, including written rating scales, blood work, and heart rate tests.
- Conditions
- Opioid Use Disorder
- Being tested
- Mobile Mindfulness Training
- Keywords
- opioid use disorder, mindfulness, childhood trauma, treatment
- 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.
Mobile Mindfulness TrainingBehavioural
Also called Headspace
Participants will be instructed to complete a mobile application-based mindfulness training daily for 30 days.
| Study group | Role | What they receive |
|---|---|---|
| Treatment As Usual First | Active comparator | This is a crossover trial. Participants in this study arm will have 30 days of treatment as usual then a 14 day washout and then 30 days of mobile mindfulness training Receives: Behavioral: Mobile Mindfulness Training |
| Mobile Mindfulness First | Experimental | This is a crossover trial. Participants in this arm will have 30 days of mobile mindfulness training first then a 14 day washout and then 30 days of treatment as ususal. Receives: Behavioral: Mobile Mindfulness Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Access
Proportion of enrolled participants who access the online mobile mindfulness training (mMT) application at least once.
Measured: 75 days after enrollment
Proportion of Acceptability
Proportion of enrolled active condition participants who report using the online mobile mindfulness training application at least 25 times in 30 days.
Measured: 75 days after enrollment
Secondary outcomes (2)
Change in Trauma Symptoms
Self-reported changes in trauma symptoms as measured by the Post-Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual-5 between baseline and 180 days after enrollment. Items are summed to provide a total severity score (range 0-80) with higher scores indicating more symptoms of trauma.
Measured: 180 days after enrollment
Change in Mindfulness
Self-reported changes in mindfulness between as measured by the Five Factor Mindfulness Questionnaire. The Five Factor Mindfulness Questionnaire (FFMQ). It examines 5 key domains of mindfulness: observing, describing, acting with awareness, nonjudging of inner experience, and nonreactivity to inner experience. Scores range from 39 to 195, with higher scores indicating greater tendency to be mindful.
Measured: 180 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start29 Jul 2025
- Primary completionJul 2028 (estimated)
- Study completionJan 2029 (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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amy Meadows
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, Amy Meadows, University of Kentucky
- Investigators
- Amy Meadows, M.D., Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06857968
- Sponsor's protocol ID
- 97193
- Other IDs
- K23DA054309
- Status last verified
- Jun 2026
- First submitted
- 3 Mar 2025
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the study period, all identifiers will be removed from data and specimen, but the de-identified dataset free of PHI specifiers will be uploaded to a data sharing service.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Opioid Use Disorder Treatment Engagement Using Mobile Mindfulness in Childhood Trauma Survivors
- ClinicalTrials.gov ID
- NCT06857968
- Acronym / sponsor ID
- 97193
- Conditions
- Opioid Use Disorder
- Keywords
- opioid use disorder, mindfulness, childhood trauma, treatment
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Amy MeadowsUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 29 Jul 2025 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 5 Mar 2025 (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.
The goal of this clinical trial is to learn if mobile mindfulness training can help people in treatment for opioid use disorder. The main questions it aims to answer are:
- Will people with opioid use disorder and childhood trauma use mobile mindfulness training?
- Will mobile mindfulness training help people with opioid use disorder and childhood trauma have decreased markers of psychological stress?
Participants will:
Be given access to mobile mindfulness training and encouragement to use it daily for 30 days.
Keep a diary of how often mobile mindfulness training is used. Visit the clinic four times to measure stress levels, including written rating scales, blood work, and heart rate tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment As Usual First | Active comparator | Behavioral: Mobile Mindfulness TrainingThis is a crossover trial. Participants in this study arm will have 30 days of treatment as usual then a 14 day washout and then 30 days of mobile mindfulness training |
| Mobile Mindfulness First | Experimental | Behavioral: Mobile Mindfulness TrainingThis is a crossover trial. Participants in this arm will have 30 days of mobile mindfulness training first then a 14 day washout and then 30 days of treatment as ususal. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinically diagnosed with Opioid Use Disorder (per DSM5 criteria)
- Currently enrolled in treatment for Opioid Use Disorder at a clinic affiliated with UKHealthCare or University of Kentucky
- On a stable dose of buprenorphine, buprenorphine/naloxone, or naloxone (i.e., at least 30 days post-induction and on a stable dose for 30 days)
- Able to read and understand English
- Have a history of childhood trauma as measured by the Adverse Childhood Experiences scale and/or Childhood Trauma Questionnaire.
Key exclusion criteria (6 listed)
- Currently taking a beta-blocker, calcium-channel blocker, antiarrhythmic, corticosteroid, or immune modulator medication
- Uncontrolled acute or chronic health conditions (e.g., active infections, autoimmune conditions, cancer undergoing active treatment)
- Current or expected pregnancy
- Current mindfulness practice (i.e., participant reports practicing mindfulness for 10 minutes or more per week)
- Primary psychotic illness
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 |
|---|---|---|
| Mobile Mindfulness TrainingAlso: HeadspaceParticipants will be instructed to complete a mobile application-based mindfulness training daily for 30 days. | Behavioural | Mobile Mindfulness First, Treatment As Usual First |
Primary outcome
Feasibility of Access
Time frame: 75 days after enrollment
Proportion of enrolled participants who access the online mobile mindfulness training (mMT) application at least once.
Proportion of Acceptability
Time frame: 75 days after enrollment
Proportion of enrolled active condition participants who report using the online mobile mindfulness training application at least 25 times in 30 days.
2 secondary outcomes
Change in Trauma Symptoms
Time frame: 180 days after enrollment
Change in Mindfulness
Time frame: 180 days after enrollment
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 8 Jun 2026.
- Individual participant dataSharing planned: Yes. After the study period, all identifiers will be removed from data and specimen, but the de-identified dataset free of PHI specifiers will be uploaded to a data sharing service.
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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.
Amy Meadows, M.D. principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Mindfulness Training in people with Opioid Use Disorder, run by Amy Meadows 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 5 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: enrolling by invitation, as of the sponsor's last update on 8 Jun 2026. 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Access (time frame: 75 days after enrollment). The study lists 2 primary outcomes in all. 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 8 Jun 2026.