Opioid Use Disorder (OUD)OASISNCT07350148
Opioid Adherence and Support Through Innovative Texting Strategies
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 on medication adherence and managing craving, pain, and withdrawal symptoms in people taking medications for opioid use disorder through assessment questions collected twice daily during the course of treatment. 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
- 13 Oct 2025to Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Have a cellphone that can receive text messages
- Have internet access to complete study surveys
- Willing to comply with all study procedures and be available for the duration of the study
- Within 6 months of starting or resuming to take daily methadone or buprenorphine (or suboxone/subutex)
- Able to understand study requirements and provide informed consent
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, fschwebel@unm.edu
Frank Schwebel, PhD
About this study
Official title: Integrating Mindfulness and mHealth Approaches for Treating Opioid Use Disorder
The goal of this clinical trial is to examine the effects of reminder and mindfulness text messages on medication adherence and managing craving, pain, and withdrawal symptoms in people taking medications for opioid use disorder through assessment questions collected twice 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?
- What impact does daily mindfulness text message quantity have on craving, pain, forgetfulness, and withdrawal symptoms?
Read more
Participants will:
- Receive daily medication reminder text messages for at least 24 weeks (i.e., 6 months)
- Receive up to 6 mindfulness messages per day for 4 weeks (i.e., 1 month)
- Answer daily questions twice a day during the 4 weeks of mindfulness messages
- Answer questions about the study when enrolling, at the end of the 4 weeks of mindfulness messages, and at 4 and 16 weeks after the end of the mindfulness messages
Read the detailed description
This study will examine the acceptability, feasibility, and effectiveness of mindfulness text messages in increasing adherence to medications for opioid use disorder and in helping people manage pain, craving, and withdrawal symptoms. The study sends up to six daily mindfulness text messages for 4 weeks as well as daily medication reminder text messages for at least 24 weeks. The study uses a micro-randomized trial design and participants are randomized each day to receive a random number of mindfulness messages (range: 0 to 6). The investigators will compare self-reported daily medication adherence to typical rates reported in the literature. Additionally, the study will examine the impact of text message quantity on primary constructs of interest (craving, pain/pain interference, withdrawal symptoms). Secondary constructs of interest collected during the mindfulness texting period include message engagement, state mindfulness, state values-based living, substance misuse, and self-efficacy. People (n=60) who report initiating or restarting taking daily medication for opioid use disorder (e.g., methadone, buprenorphine/suboxone/subutex) will be enrolled in the study. Participants will answer questions about their functioning, mood, quality of life, sleep, substance use, pain, and more at baseline, and at follow-up months 1, 2, and 6 (4, 8, and 24 weeks).
- 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 250 text messages based on concepts from Mindfulness-Based Relapse Prevention (MBRP) were developed and are sent to participants each day for 4 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 text messages | Experimental | Not described Receives: Behavioral: Mindfulness text messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mindfulness text intervention engagement
Participants reply to a binary ("Today, did you think about or use any suggestion from the OASIS Study text messages?") and continuous ("How much did you think about or use any suggestion from the OASIS text messages?; response range: 0=not at all, 10=very much) question about intervention engagement. They also indicate how much they believe the texting helped them manage their pain, urge to use opioids, remember to take their medication, and manage their withdrawal symptoms (response range: 0=not at all, 10=very much).
Measured: Measured daily for four weeks
Intervention acceptability
Responding to EMA on 25%, 50%, and 75% of days will indicate a low, medium, and high level of acceptability, respectively. An adapted version of a message fatigue measure and a scale of intervention engagement will be used with a response greater than 3 (1 to 5 scales) on each item representing at least some satisfaction with treatment and will serve as the benchmark for acceptability.
Measured: From baseline to 24-week (i.e., 6-month) follow-up
Intervention feasibility
Feasibility benchmarks are assessed continually thoughout the study, beginning with the recruitment rate of eligible participants (≥50% of potential participants) and continuing as quantified by retention at 4 weeks (≥75%), 8 weeks (≥65%), and 24 weeks (≥55%). These data are all proportions and are collected as continuous measures of feasibility as quantified by participant engagement.
Measured: From baseline to 24-week (i.e., 6-month) follow-up
Medication adherence
Medication for opioid use disorder (MOUD) adherence rate is assessed within individuals. Within-subject adherence will be quantified as ≥80% of days taking MOUD. Six-month between-subject retention rates will be classified using the following ranges based on results from prior studies of buprenorphine and methadone adherence. Buprenorphine: 25% or less = low, 25 to 40% = moderate, and 40% or greater = high. Methadone: 40% of less = low, 40 to 50% = moderate, 50% or greater = high.
Measured: From baseline to 24-week (6-month) follow-up
Secondary outcomes (8)
Mindfulness text intervention engagement
Participants indicate how much they believe the texting 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 four 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 twice daily for four weeks
Pain
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 twice daily for four 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 twice daily for four weeks
Craving
Craving is assessed using 3-items asking participants to rate the: strength of their desire, craving, and urge to use opioids on an 11-point response scale ranging from 0 (not at all) to 10 (very much).
Measured: Measured twice daily for four 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 twice daily for four weeks
Values
Values are assessed using two-items adapted from the Values Tracker for EMA measuring engaged with actions that contibute to their quality of living and making progress in life areas that matter to participants. Participants respond on an 11-point response scale ranging from 0 (not at all) to 10 (extremely).
Measured: Measured daily for four weeks
Sleep
Sleep is assessed using three-items. Two are adapted from the Pittsburgh Sleep Quality Index (items 4 and 9) and measure hours of actual sleep (from less than 4 hours to 9 or more hours) and sleep quality rating (from very good [1] to very bad [4]). Participants are also asked to rate how rested they feel ranging from very good (1) to very bad (4).
Measured: Measured daily for four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start13 Oct 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 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 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
- Not applicable
- Intervention model
- Single group
- Model description
- The study uses a micro-randomized trial design which randomizes the number of mindfulness text messages sent to each participant each day.
- Masking
- None (open label)
- 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
- NCT07350148
- Sponsor's protocol ID
- 2507214546
- Other IDs
- K23DA058015
- Acronym
- OASIS
- Status last verified
- Jan 2026
- First submitted
- 14 Jan 2026
- Last updated
- 20 Jan 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 20 Jan 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
- ClinicalTrials.gov ID
- NCT07350148
- Acronym / sponsor ID
- OASIS / 2507214546
- 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
- 13 Oct 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 20 Jan 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 on medication adherence and managing craving, pain, and withdrawal symptoms in people taking medications for opioid use disorder through assessment questions collected twice 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?
- What impact does daily mindfulness text message quantity have on craving, pain, forgetfulness, and withdrawal symptoms?
Participants will:
- Receive daily medication reminder text messages for at least 24 weeks (i.e., 6 months)
- Receive up to 6 mindfulness messages per day for 4 weeks (i.e., 1 month)
- Answer daily questions twice a day during the 4 weeks of mindfulness messages
- Answer questions about the study when enrolling, at the end of the 4 weeks of mindfulness messages, and at 4 and 16 weeks after the end of the mindfulness messages
Detailed description
This study will examine the acceptability, feasibility, and effectiveness of mindfulness text messages in increasing adherence to medications for opioid use disorder and in helping people manage pain, craving, and withdrawal symptoms. The study sends up to six daily mindfulness text messages for 4 weeks as well as daily medication reminder text messages for at least 24 weeks. The study uses a micro-randomized trial design and participants are randomized each day to receive a random number of mindfulness messages (range: 0 to 6). The investigators will compare self-reported daily medication adherence to typical rates reported in the literature. Additionally, the study will examine the impact of text message quantity on primary constructs of interest (craving, pain/pain interference, withdrawal symptoms). Secondary constructs of interest collected during the mindfulness texting period include message engagement, state mindfulness, state values-based living, substance misuse, and self-efficacy. People (n=60) who report initiating or restarting taking daily medication for opioid use disorder (e.g., methadone, buprenorphine/suboxone/subutex) will be enrolled in the study. Participants will answer questions about their functioning, mood, quality of life, sleep, substance use, pain, and more at baseline, and at follow-up months 1, 2, and 6 (4, 8, and 24 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study uses a micro-randomized trial design which randomizes the number of mindfulness text messages sent to each participant each day.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness text messages | Experimental | Behavioral: Mindfulness text messages |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age or older
- Have a cellphone that can receive text messages
- Have internet access to complete study surveys
- Willing to comply with all study procedures and be available for the duration of the study
- Within 6 months of starting or resuming to take daily methadone or buprenorphine (or suboxone/subutex)
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 250 text messages based on concepts from Mindfulness-Based Relapse Prevention (MBRP) were developed and are sent to participants each day for 4 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 text messages |
Primary outcome
Mindfulness text intervention engagement
Time frame: Measured daily for four weeks
Participants reply to a binary ("Today, did you think about or use any suggestion from the OASIS Study text messages?") and continuous ("How much did you think about or use any suggestion from the OASIS text messages?; response range: 0=not at all, 10=very much) question about intervention engagement. They also indicate how much they believe the texting helped them manage their pain, urge to use opioids, remember to take their medication, and manage their withdrawal symptoms (response range: 0=not at all, 10=very much).
Intervention acceptability
Time frame: From baseline to 24-week (i.e., 6-month) follow-up
Responding to EMA on 25%, 50%, and 75% of days will indicate a low, medium, and high level of acceptability, respectively. An adapted version of a message fatigue measure and a scale of intervention engagement will be used with a response greater than 3 (1 to 5 scales) on each item representing at least some satisfaction with treatment and will serve as the benchmark for acceptability.
Intervention feasibility
Time frame: From baseline to 24-week (i.e., 6-month) follow-up
Feasibility benchmarks are assessed continually thoughout the study, beginning with the recruitment rate of eligible participants (≥50% of potential participants) and continuing as quantified by retention at 4 weeks (≥75%), 8 weeks (≥65%), and 24 weeks (≥55%). These data are all proportions and are collected as continuous measures of feasibility as quantified by participant engagement.
Medication adherence
Time frame: From baseline to 24-week (6-month) follow-up
Medication for opioid use disorder (MOUD) adherence rate is assessed within individuals. Within-subject adherence will be quantified as ≥80% of days taking MOUD. Six-month between-subject retention rates will be classified using the following ranges based on results from prior studies of buprenorphine and methadone adherence. Buprenorphine: 25% or less = low, 25 to 40% = moderate, and 40% or greater = high. Methadone: 40% of less = low, 40 to 50% = moderate, 50% or greater = high.
8 secondary outcomes
Mindfulness text intervention engagement
Time frame: Measured daily for four weeks
Mindfulness
Time frame: Measured twice daily for four weeks
Pain
Time frame: Measured twice daily for four weeks
Pain interference
Time frame: Measured twice daily for four weeks
Craving
Time frame: Measured twice daily for four weeks
Self-efficacy
Time frame: Measured twice daily for four weeks
Values
Time frame: Measured daily for four weeks
Sleep
Time frame: Measured daily for four 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 20 Jan 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 6 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 20 Jan 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, fschwebel@unm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mindfulness text intervention engagement (time frame: Measured daily for four weeks). The study lists 4 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 20 Jan 2026.