Opioid Adherence and Support Through Innovative Texting Strategies

Официальное название

Integrating Mindfulness and mHealth Approaches for Treating Opioid Use Disorder

Обзор

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

Подробное описание

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).

Вмешательства

• Поведенческое Mindfulness text messages
  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.

Первичные конечные точки

• Mindfulness text intervention engagement [Срок оценки: Measured daily for four weeks]
• Intervention acceptability [Срок оценки: From baseline to 24-week (i.e., 6-month) follow-up]
• Intervention feasibility [Срок оценки: From baseline to 24-week (i.e., 6-month) follow-up]
• Medication adherence [Срок оценки: From baseline to 24-week (6-month) follow-up]

Вторичные конечные точки (8)

• Mindfulness text intervention engagement [Срок оценки: Measured daily for four weeks]
• Mindfulness [Срок оценки: Measured twice daily for four weeks]
• Pain [Срок оценки: Measured twice daily for four weeks]
• Pain interference [Срок оценки: Measured twice daily for four weeks]
• Craving [Срок оценки: Measured twice daily for four weeks]
• Self-efficacy [Срок оценки: Measured twice daily for four weeks]
• Values [Срок оценки: Measured daily for four weeks]
• Sleep [Срок оценки: Measured daily for four weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• None

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of New Mexico — Albuquerque

Идентификаторы

NCT: NCT07350148 · 2507214546 · K23DA058015

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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