Opioid Adherence and Support Through Innovative Texting Strategies

NCT07350148 | Recruiting

• 2 other identifiers: 2507214546K23DA058015
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.What impact does daily mindfulness text message quantity have on craving, pain, forgetfulness, and withdrawal symptoms?
4. 4.Receive daily medication reminder text messages for at least 24 weeks (i.e., 6 months)
5. 5.Receive up to 6 mindfulness messages per day for 4 weeks (i.e., 1 month)
6. 6.Answer daily questions twice a day during the 4 weeks of mindfulness messages
7. 7.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

Conditions

Opioid Use Disorder (OUD); Chronic Pain

Keywords

text message; medications for opioid use disorder; mHealth; mindfulness; medication adherence

Outcome Measures

Primary Outcomes (4)

• 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 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.

  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.

  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.

  From baseline to 24-week (6-month) follow-up

Secondary Outcomes (8)

• Mindfulness text intervention engagement

  Measured daily for four weeks

• Mindfulness

  Measured twice daily for four weeks

• Pain

  Measured twice daily for four weeks

• Pain interference

  Measured twice daily for four weeks

• Craving

  Measured twice daily for four weeks

Study Arms (1)

Mindfulness text messages

EXPERIMENTAL

Behavioral: Mindfulness text messages

Interventions

Mindfulness text messages BEHAVIORAL

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.

Mindfulness text messages

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• University of New Mexico: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders; Chronic Pain; Medication Adherence

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Frank Schwebel, PhD

CONTACT

505-456-3014; fschwebel@unm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: All data are collected online, without the research team's involvement
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study uses a micro-randomized trial design which randomizes the number of mindfulness text messages sent to each participant each day.

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: January 20, 2026
• Study Start: October 13, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2029
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

US (1)