An interventional study of Mindfulness text messages in Opioid Use Disorder (OUD) and Chronic Pain, sponsored by University of New Mexico. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-17.
Sponsored by University of New Mexico · Not applicable, Interventional, and Treatment
Among 1,222 studies in Opioid-Related Disorders with a site in United States — 246 open to participants now, 316 under way, 20 of them phase 3. Opioid-Related Disorders · United States.
Among the 1,222 studies in Opioid-Related Disorders with a site in United States, this one is the 512th largest by planned enrollment of the 1,097 interventional ones that give a count, is one of 89 that started in 2025, is one of 569 with no phase, reaches primary completion later than 164 of the 315 other live ones, and was the 1,201st registered.
1,472 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
Browse Opioid-Related Disorders studies →246 of the 1,222 studies in Opioid-Related Disorders with a site in United States are open now. Recruiting first, the newest first:
Washington State University · Sites in United States
University of Massachusetts, Worcester · Sites in United States
Baylor College of Medicine · Sites in United States
Yale University · Sites in United States
Adneuris Therapeutics, Inc. · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 210 Opioid-Related Disorders studies recruiting now, 122 (58%) set no upper age limit and 74 (35%) stop at 75 or younger; 14 take children under 18; 52 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,222 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 162 · Phase 2 245 · Phase 3 100 · Phase 4 79
First in 1988; this study’s year is marked. 89 started in 2025.
This study's planned enrollment of 60 is close to the median of 63 across 1,166 interventional studies indexed under Opioid-Related Disorders.
Median enrollment 56 across the 1,097 interventional studies, 85 across the 122 observational. Of the 833 that completed or were terminated, 331 (40%) have results posted.
This tab as a report to print or save as PDF → With an account.
132 of 1,222 have an industry lead sponsor. The 10 most frequent:
University of New Mexico is the lead sponsor of 313 studies on the registry; 29 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 23 (92%) have results posted.
University of New Mexico has 7 studies filed under Opioid-Related Disorders — fewer than ten, so there is no comparison to draw.
127 of the studies in Opioid-Related Disorders with a site in United States that are under way reach primary completion within a year, 9 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05011266Phase 3New York State Psychiatric InstituteEfficacy of Buprenorphine and XR-Naltrexone Combination for Relapse Prevention in Opioid Use Disorder | 2027-01-01 |
| NCT05834478Phase 3Emory UniversityNon-invasive Vagal Nerve Stimulation in Opioid Use Disorders UH3 | 2027-02 |
| NCT05033028Phase 3NYU Langone HealthSmartphones for Opiate Addiction Recovery | 2027-06-01 |
| NCT05459402Phase 3University of Maryland, BaltimoreDivided or Single Exposure (DOSE) Study | 2027-06-01 |
| NCT05766631Phase 3Friends Research Institute, Inc.Treating Polysubstance Use Using a Novel Digital Technology | 2027-06-30 |
Among the 1,222 studies in Opioid-Related Disorders with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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:
Participants will:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Behavioral: Mindfulness text messages
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.
Behavioral: Mindfulness text messages
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.
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).
Time frame: 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.
Time frame: 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.
Time frame: From baseline to 12-week (i.e., 3-month) follow-up
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).
Time frame: 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).
Time frame: 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".
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: Measured daily for six weeks
Started Apr 2025 (actual). Primary completion is estimated for Jul 2027, 27 months after the start.
Of 464 non-industry interventional studies with no phase under Opioid-Related Disorders, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 47. This study's planned 27 months is close to that.
Counting every sponsor, half of 495 studies reached it within 29 months; a quarter within 13 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
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