Opioid Adherence and Support Through Innovative Texting Strategies

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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

Eligibility

Primary outcome measure(s)

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

Trial sites (1)

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