Text Intervention to Facilitate Secure Storage and Disposal of Prescription Opioids

Study Overview
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Brief Summary
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The proposed study aims to develop and implement a text message intervention that will instruct and motivate individuals to securely store opioid medications during treatment and subsequently dispose of unused medications following treatment. It is relevant to public health as it is expected to meet the critical need of reducing the diversion of prescription opioids for nonmedical use. The proposed research is relevant to National Institute on Drug Abuse's priorities to develop and implement theoretically based, prevention interventions that can be scalable in healthcare settings to elicit population-level impacts to address the opioid crisis.

Detailed Description
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Drug overdoses are now the leading cause of injury-related death in the United States (US), 35% of which are due to nonmedical use of a prescribed opioid. In the US, 3.3 million people aged 12 or older report past 30-day nonmedical prescription opioid use (NMPOU), defined as use of a prescribed opioid analgesic without a prescription or for reasons other than prescribed. The existing supply of opioid analgesics is high; the prescribing rate equates to at least one opioid prescription per resident in the highest prescribing counties. Many of these opioid analgesics are leftover following treatment and kept in homes rather than being disposed after ceasing use or expiration. Over half of individuals who report NMPOU obtain prescription medications from a relative or friend, with or without their knowledge. Thus, diversion of excess medication is the primary source of NMPOU. Secure storage and disposal of unused opioid analgesics has been extensively promoted at the federal level and adopted by local communities as a strategy to combat diversion of NMPOU. The premise underlying these two strategies is that (1) secure storage minimizes the likelihood of diversion while opioid analgesics are being used during treatment and (2) disposal programs provide opportunities for patients to remove unused or expired opioids outside the home, ultimately reducing availability for NMPOU. However, recent evidence demonstrates that a majority of individuals do not securely store opioids analgesics and only a fraction of unused prescription opioids are disposed of through these take-back events and dropboxes. This is likely due, in part, to a widespread failure of knowledge about and lack of motivation to securely storing and disposing unused prescription opioids. There is evidence that increasing awareness of storage procedures and disposal mechanisms and targeted interventions delivered by healthcare systems may enhance secure storage and disposal of opioid medications. Mobile phone text message reminders, a technology used to prompt multiple health behaviors, may address the need to provide timely guidance on proper handling of opioid medications by prompting patients to securely store and dispose unused prescription opioids.

Official Title
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Development and Pilot Randomized Control Trial of a Text Message Intervention to Facilitate Secure Storage and Disposal of Prescription Opioids to Prevent Diversion and Misuse

Conditions
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Opioid Misuse

Intervention / Treatment
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* Other: Text Message
* Other: Pamphlet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older able to read and speak English owning a cell phone with the capability of receiving short message service (SMS) text messages receiving an opioid prescription within the past 7 days Exclusion Criteria: 17 years or younger not able to read and speak English does not own a cell phone with the capability of receiving SMS text messages, and -has not received an opioid prescription within the past 7 days

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Text Message Intervention Study Condition<br>The intervention is a text message intervention. Text messages will provide guidance on secure storage and disposal of prescription opioids to participants who have been dispensed a prescription opioid. Participants in the intervention study condition will receive a series of text messages that aim to facilitate secure storage and disposal of unused opioid prescriptions. In addition to the text messages, participants assigned to the intervention study condition will receive a informational pamphlet with information about secure storage and disposal of prescription opioids. | Other: Text Message<br>* The intervention consists of a series of text messages aimed to facilitate secure storage and disposal of unused opioid medications.<br>Other: Pamphlet<br>* Informational pamphlet with guidance on secure storage and disposal of prescription opioids.<br>|
| Active Comparator: Control Study Condition<br>Participants assigned to the control study condition will receive a standard of care alternative treatment. Participants assigned to the control study condition will receive an informational pamphlet with information about secure storage and disposal of prescription opioids. Participants assigned to the control study condition will not receive the text message intervention. | Other: Pamphlet<br>* Informational pamphlet with guidance on secure storage and disposal of prescription opioids.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants who securely stored their opioid medication during treatment | Investigators will assess the differences in the proportions of participants who securely stored their opioid medication during treatment using a dichotomous, close-ended question on a self-administered questionnaire. | 30 days following enrollment | 
| Proportion of participants who disposed of their unused opioid medication | Investigators will assess the differences in the proportions of participants who disposed of their unused opioid medication following completion of treatment using a dichotomous, close-ended question on a self-administered questionnaire. | 30 days following enrollment |