NCT07711795

Brief 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 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:

  1. 1.Do daily medication reminder text messages increase medication adherence for people taking medications for opioid use disorder?
  2. 2.To what extent do people engage with the daily mindfulness messages?
  3. 3.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?
  4. 4.How do the two mindfulness text messaging interventions differ in their effects on intervention engagement, craving, pain, mindfulness, and withdrawal symptoms?
  5. 5.Receive daily medication reminder text messages for 12 weeks (i.e., 3 months)
  6. 6.Receive either 2 or 4 mindfulness messages per day for 6 weeks
  7. 7.Answer brief assessment questions six times per day during the 6-week mindfulness text messaging period
  8. 8.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)

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
14mo left

Started Apr 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress52%
Apr 2025Oct 2027

Study Start

First participant enrolled

April 23, 2025

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 17, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

July 17, 2026

Status Verified

July 1, 2026

Enrollment Period

2.2 years

First QC Date

July 13, 2026

Last Update Submit

July 13, 2026

Conditions

Opioid Use Disorder (OUD)Chronic Pain

Keywords

text messagemedications for opioid use disordermHealthmindfulnessmedication adherence

Outcome Measures

Primary Outcomes (3)

  • 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 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.

    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.

    From baseline to 12-week (i.e., 3-month) follow-up

Secondary Outcomes (10)

  • Perceived benefits of mindfulness text messages

    Measured daily for six weeks

  • Mindfulness

    Measured daily for six weeks

  • Pain Measurement

    Measured daily for six weeks

  • Pain interference

    Measured daily for six weeks

  • Medication adherence

    From baseline to 12-week (i.e., 3-month) follow-up

  • +5 more secondary outcomes

Study Arms (2)

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.

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.

Behavioral: Mindfulness text messages

Interventions

Mindfulness text messagesBEHAVIORAL

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.

Mindfulness curriculumRandom mindfulness messages

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related DisordersChronic PainMedication Adherence

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Central Study Contacts

Frank Schwebel, PhD

CONTACT

505-456-3014textlabresearch@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2026

First Posted

July 17, 2026

Study Start

April 23, 2025

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

July 17, 2026

Record last verified: 2026-07

Locations

US(1)