Opioid Use Disorder (OUD)MiMANCT07711795
Mindfulness Texting for Medication Adherence and Chronic Pain Management
A study testing Mindfulness text messages in people with Opioid Use Disorder (OUD) and Chronic Pain, run by University of New Mexico at 1 site in United States.
Trial summary
The goal of this clinical trial is to examine the effects of reminder and mindfulness text messages based on integrated Acceptance and Commitment Therapy and Mindfulness Based Relapse Prevention (ACT+MBRP) on medication adherence and managing craving, pain, mindfulness, and withdrawal symptoms in people taking… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder (OUD), Chronic Pain
- What is being tested?
- Mindfulness text messages
- 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
- 23 Apr 2025to Oct 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Reside in the United States
- Own or have access to a mobile phone capable of sending and receiving text messages
- Have reliable internet access to complete study surveys
- Be willing and able to comply with all study procedures and remain available for the duration of the study
- Be interested in receiving medication reminders and mindfulness text messages
Show all 9Show fewer
- Be within 2 months of initiating or restarting methadone or buprenorphine treatment for opioid use
- Report chronic pain (pain lasting at least 3 months)
- Live in the United States
Who cannot join
- None
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
University of New Mexico
Albuquerque, New Mexico, 87131
Frank Schwebel, PhD, 505-456-3014, textlabresearch@gmail.com
About this study
Official title: Integrating Mindfulness and mHealth Approaches for Treating Opioid Use Disorder and Chronic Pain
The goal of this clinical trial is to examine the effects of reminder and mindfulness text messages based on integrated Acceptance and Commitment Therapy and Mindfulness Based Relapse Prevention (ACT+MBRP) on medication adherence and managing craving, pain, mindfulness, and withdrawal symptoms in people taking medications for opioid use disorder and with chronic pain through assessment questions collected six times daily during the course of treatment. The main questions it aims to answer are:
- Do daily medication reminder text messages increase medication adherence for people taking medications for opioid use disorder?
- To what extent do people engage with the daily mindfulness messages?
- Do participants receiving a structured curriculum of mindfulness messages delivered twice daily differ from those receiving randomly selected mindfulness messages delivered four times daily in engagement with the intervention?
- How do the two mindfulness text messaging interventions differ in their effects on intervention engagement, craving, pain, mindfulness, and withdrawal symptoms?
Read more
Participants will:
- Receive daily medication reminder text messages for 12 weeks (i.e., 3 months)
- Receive either 2 or 4 mindfulness messages per day for 6 weeks
- Answer brief assessment questions six times per day during the 6-week mindfulness text messaging period
- Complete questionnaires at enrollment (baseline), once each week during the 6-week mindfulness text messaging period (6 total), immediately after the 6-week mindfulness text messaging period (post-treatment), and 6 weeks after the mindfulness text messaging period ends (follow-up)
Read the detailed description
This study will examine the acceptability, feasibility, and effectiveness of mindfulness text messages for increasing adherence to medication for opioid use disorder and helping participants manage pain, pain interference, craving, withdrawal symptoms, and mindfulness. The study sends either two or four daily mindfulness text messages for six weeks as well as daily medication reminder text messages for 12 weeks. Participants in the two message per day condition receive an identical curriculum of messages developed based on the integrated ACT+MBRP manual (e.g., the same messages in the same order). Message delivery time is randomized to one of six windows throughout the day. Participants in the four message per day condition receive four random messages from our pool of over 200 mindfulness messages (e.g., different messages and order for each participant). Message delivery time is also randomized to one of the same six windows throughout the day as the other condition. Participants are blinded to the differences in conditions. Medication adherence will be assessed using daily self-report throughout the study.
The study will compare the effects of the two mindfulness text messaging interventions on craving, pain, pain interference, mindfulness, and medication adherence. Secondary outcomes include engagement with the mindfulness text messages, state mindfulness, values-based living, substance misuse, and self-efficacy. Sixty participants who are initiating or restarting medication for opioid use disorder (e.g., methadone or buprenorphine) and who have chronic pain will be enrolled. Participants will complete baseline questionnaires before beginning the intervention, brief ecological momentary assessment (EMA) questions six times per day during the 6-week mindfulness text messaging period, weekly questionnaires during the intervention (6 total), a post-treatment assessment at the end of the 6-week mindfulness text messaging period, and a follow-up assessment 6 weeks after the intervention ends. Daily medication reminder text messages will continue throughout the 12-week study period.
- Conditions
- Opioid Use Disorder (OUD), Chronic Pain
- Being tested
- Mindfulness text messages
- Keywords
- text message, medications for opioid use disorder, mHealth, mindfulness, medication adherence
- Medical subject headings
- Opioid-Related Disorders, Chronic Pain, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness text messagesBehavioural
Over 200 text messages based on concepts from Acceptance and Commitment Therapy (ACT) and Mindfulness-Based Relapse Prevention (MBRP) were developed and are sent to participants each day for 6 weeks. The messages are intended to increase awareness of triggers and "automatic" reactions to triggering experiences, and to consider alternative responses to these experiences.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness curriculum | Experimental | Participants in this condition receive two mindfulness messages per day at random times as part of a curriculum based on the ACT+MBRP treatment manual. Receives: Behavioral: Mindfulness text messages |
| Random mindfulness messages | Experimental | Participants in this condition receive four random mindfulness messages per day at random times from the complete bank of mindfulness messages developed based on the Monitoring and Acceptance Theory of mindfulness. Receives: Behavioral: Mindfulness text messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engagement with mindfulness text messages
Engagement with the mindfulness text messages is assessed using one binary item asking whether participants thought about or used any suggestion from the MiMA Study text messages since that morning and one 11-point rating (0 = not at all to 10 = very much) assessing the extent to which participants thought about or used the suggestions. Participants also rate the extent to which the mindfulness text messages helped them manage pain, opioid craving, medication adherence, and withdrawal symptoms (0 = not at all to 10 = very much).
Measured: Measured daily for six weeks
Intervention acceptability
Acceptability will be assessed using an adapted message fatigue questionnaire and intervention engagement scale. Items are rated on 5-point Likert scales, with mean scores greater than 3 indicating acceptable levels of intervention satisfaction.
Measured: From baseline to 12-week (i.e., 3-month) follow-up
Intervention feasibility
Feasibility will be evaluated using recruitment, retention, and survey completion rates. Prespecified benchmarks include recruitment of at least 50% of eligible participants and retention rates of at least 75%, 65%, and 55% at Weeks 3, 6, and 12, respectively. Responding to EMA on 25%, 50%, and 75% of days will indicate a low, medium, and high level of feasibility, respectively.
Measured: From baseline to 12-week (i.e., 3-month) follow-up
Secondary outcomes (10)
Perceived benefits of mindfulness text messages
Participants indicate how much they believe the mindfulness text messages helped them engage in valued activities, engage in everyday activities, be mindful, and accept thoughts and situations without judgement (response range: 0=not at all, 10=very much).
Measured: Measured daily for six weeks
Mindfulness
Mindfulness will be assessed through a 6-item EMA scale that measures state mindfulness in the past 15 minutes. Responses are made on a 5-point response scale ranging from 1 (not at all) to 5 (very much).
Measured: Measured daily for six weeks
Pain Measurement
Pain is assessed using a single-item asking participants to rate their current pain compared to their typical pain level. Responses are made on a 10-point response scale ranging from 0 (a lot less than usual) to 10 (a lot more than usual). A response of 5 represents "about the same as usual".
Measured: Measured daily for six weeks
Pain interference
Pain interference is assessed using two items assessing interference with what participants are doing and their enjoyment of life. Responses are made on an 11-point response scale ranging from 0 (not at all) to 10 (very much).
Measured: Measured daily for six weeks
Medication adherence
Medication adherence will be assessed using daily self-report of medication for opioid use disorder (MOUD) use. Within-participant adherence will be calculated as the percentage of study days on which participants reported taking their medication as prescribed. Participants taking medication on at least 80% of study days will be classified as adherent.
Measured: From baseline to 12-week (i.e., 3-month) follow-up
Craving
Craving is assessed using two items asking participants to rate the strength of their urge and their need to use opioids on an 11-point response scale ranging from 0 (not at all) to 10 (very much).
Measured: Measured daily for six weeks
Self-efficacy
Self-efficacy is assessed using a single item asking participants to rate their confidence in their ability to not use opioids on an 11-point response scale ranging from 0 (not at all) to 10 (very much).
Measured: Measured daily for six weeks
Values
Values-based living is assessed using two items adapted from the Values Tracker for ecological momentary assessment (EMA). The items measure engagement in actions that contribute to participants' quality of life and progress toward life areas that are important to them. Responses are made on an 11-point scale ranging from 0 (not at all) to 10 (extremely).
Measured: Measured daily for six weeks
Opioid misuse
Opioid misuse is assessed using a single item asking participants to endorse whether or not they have used non-prescription or prescription opioids more frequently than prescribed since they last completed a survey.
Measured: Measured daily for six weeks
Withdrawal symptoms
Withdrawal symptoms are assessed using one binary item asking whether participants experienced opioid withdrawal symptoms since the previous assessment and one 11-point rating assessing current withdrawal severity (0 = not at all to 10 = very much).
Measured: Measured daily for six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start23 Apr 2025
- Primary completionJul 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use Disorder (OUD)Studies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07711795
- Sponsor's protocol ID
- 2405127629
- Other IDs
- RM1DA055301
- Acronym
- MiMA
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Mindfulness and mHealth Approaches for Treating Opioid Use Disorder and Chronic Pain
- ClinicalTrials.gov ID
- NCT07711795
- Acronym / sponsor ID
- MiMA / 2405127629
- Conditions
- Opioid Use Disorder (OUD), Chronic Pain
- Keywords
- text message, medications for opioid use disorder, mHealth, mindfulness, medication adherence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 23 Apr 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 17 Jul 2026 (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 examine the effects of reminder and mindfulness text messages based on integrated Acceptance and Commitment Therapy and Mindfulness Based Relapse Prevention (ACT+MBRP) on medication adherence and managing craving, pain, mindfulness, and withdrawal symptoms in people taking medications for opioid use disorder and with chronic pain through assessment questions collected six times daily during the course of treatment. The main questions it aims to answer are:
- Do daily medication reminder text messages increase medication adherence for people taking medications for opioid use disorder?
- To what extent do people engage with the daily mindfulness messages?
- Do participants receiving a structured curriculum of mindfulness messages delivered twice daily differ from those receiving randomly selected mindfulness messages delivered four times daily in engagement with the intervention?
- How do the two mindfulness text messaging interventions differ in their effects on intervention engagement, craving, pain, mindfulness, and withdrawal symptoms?
Participants will:
- Receive daily medication reminder text messages for 12 weeks (i.e., 3 months)
- Receive either 2 or 4 mindfulness messages per day for 6 weeks
- Answer brief assessment questions six times per day during the 6-week mindfulness text messaging period
- Complete questionnaires at enrollment (baseline), once each week during the 6-week mindfulness text messaging period (6 total), immediately after the 6-week mindfulness text messaging period (post-treatment), and 6 weeks after the mindfulness text messaging period ends (follow-up)
Detailed description
This study will examine the acceptability, feasibility, and effectiveness of mindfulness text messages for increasing adherence to medication for opioid use disorder and helping participants manage pain, pain interference, craving, withdrawal symptoms, and mindfulness. The study sends either two or four daily mindfulness text messages for six weeks as well as daily medication reminder text messages for 12 weeks. Participants in the two message per day condition receive an identical curriculum of messages developed based on the integrated ACT+MBRP manual (e.g., the same messages in the same order). Message delivery time is randomized to one of six windows throughout the day. Participants in the four message per day condition receive four random messages from our pool of over 200 mindfulness messages (e.g., different messages and order for each participant). Message delivery time is also randomized to one of the same six windows throughout the day as the other condition. Participants are blinded to the differences in conditions. Medication adherence will be assessed using daily self-report throughout the study.
The study will compare the effects of the two mindfulness text messaging interventions on craving, pain, pain interference, mindfulness, and medication adherence. Secondary outcomes include engagement with the mindfulness text messages, state mindfulness, values-based living, substance misuse, and self-efficacy. Sixty participants who are initiating or restarting medication for opioid use disorder (e.g., methadone or buprenorphine) and who have chronic pain will be enrolled. Participants will complete baseline questionnaires before beginning the intervention, brief ecological momentary assessment (EMA) questions six times per day during the 6-week mindfulness text messaging period, weekly questionnaires during the intervention (6 total), a post-treatment assessment at the end of the 6-week mindfulness text messaging period, and a follow-up assessment 6 weeks after the intervention ends. Daily medication reminder text messages will continue throughout the 12-week study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness curriculum | Experimental | Behavioral: Mindfulness text messagesParticipants in this condition receive two mindfulness messages per day at random times as part of a curriculum based on the ACT+MBRP treatment manual. |
| Random mindfulness messages | Experimental | Behavioral: Mindfulness text messagesParticipants in this condition receive four random mindfulness messages per day at random times from the complete bank of mindfulness messages developed based on the Monitoring and Acceptance Theory of mindfulness. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18 years or older
- Reside in the United States
- Own or have access to a mobile phone capable of sending and receiving text messages
- Have reliable internet access to complete study surveys
- Be willing and able to comply with all study procedures and remain available for the duration of the study
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Mindfulness text messagesOver 200 text messages based on concepts from Acceptance and Commitment Therapy (ACT) and Mindfulness-Based Relapse Prevention (MBRP) were developed and are sent to participants each day for 6 weeks. The messages are intended to increase awareness of triggers and "automatic" reactions to triggering experiences, and to consider alternative responses to these experiences. | Behavioural | Mindfulness curriculum, Random mindfulness messages |
Primary outcome
Engagement with mindfulness text messages
Time frame: Measured daily for six weeks
Engagement with the mindfulness text messages is assessed using one binary item asking whether participants thought about or used any suggestion from the MiMA Study text messages since that morning and one 11-point rating (0 = not at all to 10 = very much) assessing the extent to which participants thought about or used the suggestions. Participants also rate the extent to which the mindfulness text messages helped them manage pain, opioid craving, medication adherence, and withdrawal symptoms (0 = not at all to 10 = very much).
Intervention acceptability
Time frame: From baseline to 12-week (i.e., 3-month) follow-up
Acceptability will be assessed using an adapted message fatigue questionnaire and intervention engagement scale. Items are rated on 5-point Likert scales, with mean scores greater than 3 indicating acceptable levels of intervention satisfaction.
Intervention feasibility
Time frame: From baseline to 12-week (i.e., 3-month) follow-up
Feasibility will be evaluated using recruitment, retention, and survey completion rates. Prespecified benchmarks include recruitment of at least 50% of eligible participants and retention rates of at least 75%, 65%, and 55% at Weeks 3, 6, and 12, respectively. Responding to EMA on 25%, 50%, and 75% of days will indicate a low, medium, and high level of feasibility, respectively.
10 secondary outcomes
Perceived benefits of mindfulness text messages
Time frame: Measured daily for six weeks
Mindfulness
Time frame: Measured daily for six weeks
Pain Measurement
Time frame: Measured daily for six weeks
Pain interference
Time frame: Measured daily for six weeks
Medication adherence
Time frame: From baseline to 12-week (i.e., 3-month) follow-up
Craving
Time frame: Measured daily for six weeks
Self-efficacy
Time frame: Measured daily for six weeks
Values
Time frame: Measured daily for six weeks
Opioid misuse
Time frame: Measured daily for six weeks
Withdrawal symptoms
Time frame: Measured daily for six weeks
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 17 Jul 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness text messages in people with Opioid Use Disorder (OUD) and Chronic Pain, run by University of New Mexico 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 9 inclusion and 1 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 17 Jul 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?
Contact Frank Schwebel, PhD (505-456-3014, textlabresearch@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engagement with mindfulness text messages (time frame: Measured daily for six weeks). The study lists 3 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 17 Jul 2026.