Text Message Intervention to Facilitate Secure Storage and Disposal of Prescription Opioids to Prevent Diversion and Misuse: Protocol for a Randomized Controlled Trial (Preprint)

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Abstract
BACKGROUND Nonmedical use of prescription opioids remains a critical public health issue; 8.5 million people in the United States misused opioids in 2022. Most people obtain prescription opioids for misuse from family or friends. Thus, facilitating secure storage and disposal of opioid medications during and after treatment is needed to prevent medication diversion and subsequent misuse. OBJECTIVE The primary objective of this study is to test the feasibility and efficacy of a novel intervention that uses a persuasive, informational SMS text message reminder system to enhance the impact of secure storage and disposal of unused opioid medications. We hypothesize that the SMS text message intervention will increase secure storage during treatment and disposal of prescription opioids after treatment. METHODS We will use a 2-arm randomized controlled trial to test the intervention for feasibility and efficacy. Participants (aged 18+ years who have received an opioid prescription in the past 2 weeks) will be randomly assigned to either receive the SMS text message intervention or standard-of-care educational materials. Participants in the intervention will receive 4 SMS text messages related to secure storage and 3 messages related to disposal. All participants will complete baseline, midpoint (day 25), and postintervention (day 45) evaluation surveys. We will test whether receipt of the intervention is associated with two primary outcomes, which are (1) secure storage of prescription opioid medication (locked vs unlocked) and (2) disposal of unused prescription opioid medication (disposed vs not disposed). We will use multiple logistic regression to test the main hypotheses that the intervention will be positively associated with secure storage (locked vs unlocked) and disposal (yes vs no) behaviors, which will allow us to control for demographic variables known to influence the outcomes. This protocol represents the entire structure of the randomized controlled trial. RESULTS Recruitment for the randomized controlled trial was launched in April 2024, and data collection was completed in December 2024. The final sample size is 484. Data analyses for the main hypothesis will be completed by May 2025, and the main hypothesis manuscript will be submitted for publication by May 2025. CONCLUSIONS Results from this study will indicate whether a text message reminder system can increase secure storage and disposal behaviors for individuals who receive opioid medication. This type of intervention has the potential to be integrated into currently used health care delivery systems, such as prescription pickup reminders at pharmacies. Thus, the intervention is scalable across systems of care, thus expanding the reach of secure storage and disposal programs to prevent prescription opioid misuse. CLINICALTRIAL ClinicalTrials.gov NCT05503186; https://clinicaltrials.gov/study/NCT05503186 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/60332
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