Opioid Adherence and Support Through Innovative Texting Strategies
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of New Mexico
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Mindfulness text messages
BehavioralOver 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.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Mindfulness text messagesExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Measured daily for four weeks2
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.
Time frame
From baseline to 24-week (i.e., 6-month) follow-up3
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.
Time frame
From baseline to 24-week (i.e., 6-month) follow-up4
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.
Time frame
From baseline to 24-week (6-month) follow-upSecondary outcomes
1
Mindfulness text intervention engagement
Participants indicate how much they believe the texting helped them engage in valued activities, engage in everyday activities, be mindful, and accept thoughts and situations without judgement (response range: 0=not at all, 10=very much).
Time frame
Measured daily for four weeks2
Mindfulness
Mindfulness will be assessed through a 6-item EMA scale that measures state mindfulness in the past 15 minutes. Responses are made on a 5-point response scale ranging from 1 (not at all) to 5 (very much).
Time frame
Measured twice daily for four weeks3
Pain
Pain is assessed using a single-item asking participants to rate their current pain compared to their typical pain level. Responses are made on a 10-point response scale ranging from 0 (a lot less than usual) to 10 (a lot more than usual). A response of 5 represents "about the same as usual.
Time frame
Measured twice daily for four weeks4
Pain interference
Pain interference is assessed using two items assessing interference with what participants are doing and their enjoyment of life. Responses are made on an 11-point response scale ranging from 0 (not at all) to 10 (very much).
Time frame
Measured twice daily for four weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of New Mexico
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov