Opioid Use DisorderNCT06063499
HMP for Addictions Study
A study testing Healthy Minds Program for Addictions in people with Opioid Use Disorder and Opioid Use, run by University of Wisconsin, Madison.
Trial summary
The goal of this clinical trial is to see whether the Healthy Minds Program for Addictions could be used to help veterans with moderate-severe opioid use disorder and post-traumatic stress disorder stay on buprenorphine maintenance treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder, Opioid Use, Buprenorphine Dependence
- What is being tested?
- Healthy Minds Program for Addictions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2025to Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Individuals at least 18 years of age
- English-speaking
- Veterans
- Ability to understand and willingness to sign a written informed consent document
- Have access to a smartphone, tablet, or computer with internet connection to access recordings for home practice
- Ability and willingness to attend all 6 session of the study, and to complete all assessment questionnaires
- Verified Post-Traumatic Stress Disorder (PTSD) according to DSM-5 criteria
- On buprenorphine maintenance treatment for Opioid use disorder (OUD) for a minimum of 3 months
Who cannot join
- Regular daily meditation practice for past 6 months or regular weekly meditation practice for past 12 months
- Attended a meditation retreat or a yoga/body practice retreat with a significant meditation component
- Previous use of Healthy Minds Program app
- Current suicidal intent and/or high self-injury risk, as determined from the interview
- Current psychopathology that interferes with study participation as assessed by interview
About this study
Official title: Healthy Minds Program for Veterans With Opioid Use Disorder on Buprenorphine Maintenance Treatment: A Pilot Study
The goal of this clinical trial is to see whether the Healthy Minds Program for Addictions could be used to help veterans with moderate-severe opioid use disorder and post-traumatic stress disorder stay on buprenorphine maintenance treatment.
Participants will be asked to complete a six-week program consisting of 6 weekly, 2-hour in-person group sessions, as well as assessments before the start of the sessions.
Read the detailed description
This is a 6-week, single-arm, single-center pilot study of the acceptability and efficacy of an adaptation of the Healthy Minds Program for Veterans with opioid use disorder on buprenorphine maintenance treatment.
Following the Screening Visit, eligible subjects will complete 6 in-person sessions over the course of 2 months. The first session will be an introductory session introducing the basics of the program. After the introductory session, there will be four weekly sessions, each dedicated to a different domain of the program - awareness, connection, insight, and purpose. Participants will be encouraged to practice daily anywhere from 5 to 30 minutes from a set of practices that will be available to them on a password protected website. The intervention will end with a closing session where participants will have the opportunity to reflect on their experience of the program and share feedback. Weekly sessions will be held in person and will be facilitated by an MD, PhD Psychiatrist and Neuroscientist with 8 years of mindfulness practice together with a certified Peer Support Specialist.
- Conditions
- Opioid Use Disorder, Opioid Use, Buprenorphine Dependence
- Being tested
- Healthy Minds Program for Addictions
- 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.
Healthy Minds Program for AddictionsBehavioural
The Healthy Minds Program for Addictions is a 6-week, hybrid version of the original Healthy Minds Program (HMP), in which all lessons are adapted from the original lessons available in the app and delivered exclusively in person over weekly group sessions. The HMP has >100 guided audio practices that address 4 constituents of wellbeing: awareness, connection, insight, and purpose. Study participants will have access to specific practices from the HMP that are particularly relevant to the needs of populations with substance use disorders and trauma.
| Study group | Role | What they receive |
|---|---|---|
| 6 weeks of sessions | Experimental | Participants will be asked to attend 6 2-hour weekly in-person sessions Receives: Behavioral: Healthy Minds Program for Addictions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention in treatment
Number of participants who complete all 6 sessions, as measured through actual attendance.
Measured: Through study completion, up to 4 months
Change in predictors of relapse and recovery
The Brief Addiction Monitor (BAM) is a 17-item, multidimensional, progress-monitoring instrument for patients in treatment for a substance use disorder (SUD). The BAM includes items that assess risk factors for substance use (scores 0-24, higher scores meaning more risk), protective factors that support sobriety (scores 0-24, higher scores meaning more protection), and drug and alcohol use (scores 0-12, higher scores meaning more use). The BAM produces composite scores for the three aforementioned domains.
Measured: Baseline, 3 weeks, 6 weeks
Secondary outcomes (4)
Change in psychological distress - perceived stress
Stress will be measured using the 10-item NIH Perceived Stress Scale. Each question is scored from 0 (never) to 5 (very often). The total score ranges from 0 to 40, with higher scores indicating higher levels of stress.
Measured: Baseline, 3 weeks, 6 weeks
Change in psychological distress - anxiety and depression
Anxiety and depression will be measured using the Patient Reported Outcomes Measurement Information Systems (PROMIS) Anxiety and Depression scales. The investigators will use the computer adaptive version of both measures which have a mean of 50 and a standard deviation of 10. A composite will be computed by average across T-scores. T-scores range from 10 to 90 with higher scores indicating higher depression or anxiety.
Measured: Baseline, 3 weeks, 6 weeks
Change in PTSD symptoms
PTSD symptoms will be measured by the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (PCL-5). The PCL-5 uses a 5-point Likert scale ranging from 0-4 for each symptom. Respondents rate how bothered they have been by each item in the past month. The items are summed to provide a total severity score ranging from 0-80. Higher scores indicate a higher level of symptoms.
Measured: Baseline, 3 weeks, 6 weeks
Change in well-being
Well-being will be measured using the 17-item Healthy Minds Index (HMI). The HMI assesses qualities trained in the HMP app (awareness, connection, insight, purpose). It is scored on a 0- to 4-point Likert scale where 0 = a low amount (e.g., never, not at all, none of the time) and 4 = a higher amount (e.g., always, to the highest degree, all of the time) of a particular quality.
Measured: Baseline, 3 weeks, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study startMay 2025 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Why it stopped: prioritizing other opportunities
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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Healthy Minds
- Responsible party
- Sponsor
- Investigators
- Timothy Juergens, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06063499
- Sponsor's protocol ID
- 2024-0247
- Other IDs
- SMPH/PSYCHIATRY/PSYCHIATRY, Protocol Version 6/30/23
- Status last verified
- Feb 2025
- First submitted
- 20 Sep 2023
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Minds Program for Veterans With Opioid Use Disorder on Buprenorphine Maintenance Treatment: A Pilot Study
- ClinicalTrials.gov ID
- NCT06063499
- Acronym / sponsor ID
- 2024-0247
- Conditions
- Opioid Use Disorder, Opioid Use, Buprenorphine Dependence
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: prioritizing other opportunities
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Center for Healthy Minds
- Study start
- May 2025 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 2 Oct 2023 (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 see whether the Healthy Minds Program for Addictions could be used to help veterans with moderate-severe opioid use disorder and post-traumatic stress disorder stay on buprenorphine maintenance treatment.
Participants will be asked to complete a six-week program consisting of 6 weekly, 2-hour in-person group sessions, as well as assessments before the start of the sessions.
Detailed description
This is a 6-week, single-arm, single-center pilot study of the acceptability and efficacy of an adaptation of the Healthy Minds Program for Veterans with opioid use disorder on buprenorphine maintenance treatment.
Following the Screening Visit, eligible subjects will complete 6 in-person sessions over the course of 2 months. The first session will be an introductory session introducing the basics of the program. After the introductory session, there will be four weekly sessions, each dedicated to a different domain of the program - awareness, connection, insight, and purpose. Participants will be encouraged to practice daily anywhere from 5 to 30 minutes from a set of practices that will be available to them on a password protected website. The intervention will end with a closing session where participants will have the opportunity to reflect on their experience of the program and share feedback. Weekly sessions will be held in person and will be facilitated by an MD, PhD Psychiatrist and Neuroscientist with 8 years of mindfulness practice together with a certified Peer Support Specialist.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 6 weeks of sessions | Experimental | Behavioral: Healthy Minds Program for AddictionsParticipants will be asked to attend 6 2-hour weekly in-person sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Individuals at least 18 years of age
- English-speaking
- Veterans
- Ability to understand and willingness to sign a written informed consent document
- Have access to a smartphone, tablet, or computer with internet connection to access recordings for home practice
Key exclusion criteria (5 listed)
- Regular daily meditation practice for past 6 months or regular weekly meditation practice for past 12 months
- Attended a meditation retreat or a yoga/body practice retreat with a significant meditation component
- Previous use of Healthy Minds Program app
- Current suicidal intent and/or high self-injury risk, as determined from the interview
- Current psychopathology that interferes with study participation as assessed by interview
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 |
|---|---|---|
| Healthy Minds Program for AddictionsThe Healthy Minds Program for Addictions is a 6-week, hybrid version of the original Healthy Minds Program (HMP), in which all lessons are adapted from the original lessons available in the app and delivered exclusively in person over weekly group sessions. The HMP has >100 guided audio practices that address 4 constituents of wellbeing: awareness, connection, insight, and purpose. Study participants will have access to specific practices from the HMP that are particularly relevant to the needs of populations with substance use disorders and trauma. | Behavioural | 6 weeks of sessions |
Primary outcome
Retention in treatment
Time frame: Through study completion, up to 4 months
Number of participants who complete all 6 sessions, as measured through actual attendance.
Change in predictors of relapse and recovery
Time frame: Baseline, 3 weeks, 6 weeks
The Brief Addiction Monitor (BAM) is a 17-item, multidimensional, progress-monitoring instrument for patients in treatment for a substance use disorder (SUD). The BAM includes items that assess risk factors for substance use (scores 0-24, higher scores meaning more risk), protective factors that support sobriety (scores 0-24, higher scores meaning more protection), and drug and alcohol use (scores 0-12, higher scores meaning more use). The BAM produces composite scores for the three aforementioned domains.
4 secondary outcomes
Change in psychological distress - perceived stress
Time frame: Baseline, 3 weeks, 6 weeks
Change in psychological distress - anxiety and depression
Time frame: Baseline, 3 weeks, 6 weeks
Change in PTSD symptoms
Time frame: Baseline, 3 weeks, 6 weeks
Change in well-being
Time frame: Baseline, 3 weeks, 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- 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. This study is not recruiting at the moment.
Timothy Juergens, MD principal investigator
University of Wisconsin, Madison
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Minds Program for Addictions in people with Opioid Use Disorder and Opioid Use, run by University of Wisconsin, Madison.
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 8 inclusion and 5 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: withdrawn, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Retention in treatment (time frame: Through study completion, up to 4 months). 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 19 Feb 2025.