Clinical Trials Directory

Trials / Recruiting

RecruitingNCT07350148

Opioid Adherence and Support Through Innovative Texting Strategies

Integrating Mindfulness and mHealth Approaches for Treating Opioid Use Disorder

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
60 (estimated)
Sponsor
University of New Mexico · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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. Do daily medication reminder text messages increase medication adherence for people taking medications for opioid use disorder? 2. To what extent do people engage with the daily mindfulness messages? 3. What impact does daily mindfulness text message quantity have on craving, pain, forgetfulness, and withdrawal symptoms? Participants will: 1. Receive daily medication reminder text messages for at least 24 weeks (i.e., 6 months) 2. Receive up to 6 mindfulness messages per day for 4 weeks (i.e., 1 month) 3. Answer daily questions twice a day during the 4 weeks of mindfulness messages 4. 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).

Conditions

Interventions

TypeNameDescription
BEHAVIORALMindfulness 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.

Timeline

Start date
2025-10-13
Primary completion
2027-03-01
Completion
2029-03-01
First posted
2026-01-20
Last updated
2026-01-20

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT07350148. Inclusion in this directory is not an endorsement.