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Text Intervention to Facilitate Secure Storage and Disposal of Prescription Opioids

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05503186
Enrollment
479
Registered
2022-08-16
Start date
2024-06-14
Completion date
2024-12-09
Last updated
2026-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Misuse

Brief summary

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

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.

Interventions

OTHERText Message

The intervention consists of a series of text messages aimed to facilitate secure storage and disposal of unused opioid medications.

OTHERStandard of Care

Information provided by the physician and/or pharmacist.

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER
University of Kentucky
CollaboratorOTHER
University of North Carolina, Chapel Hill
CollaboratorOTHER
East Carolina University
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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 14 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 * has not received an opioid prescription within the past 14 days

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Participants Who Securely Stored Their Opioid Medication During Treatment45 days following enrollmentInvestigators will assess the differences in the percentage of participants who securely stored their opioid medication during treatment using a dichotomous, close-ended question on a self-administered questionnaire.
Percentage of Participants Who Disposed of Their Unused Opioid Medication45 days following enrollmentInvestigators will assess the differences in the percentage of participants who disposed of their unused opioid medication following completion of treatment using a dichotomous, close-ended question on a self-administered questionnaire.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORKathleen Egan, PhD, MS

Wake Forest University Health Sciences

Participant flow

Recruitment details

We used a multimethod approach to recruitment. Potential participants who were recently prescribed opioid medication were identified through Electronic Health Records (EHR) and sent a single message in their MyChart inviting them to participate. We also posted flyers in local pharmacies with study information. Participants were directed to an online consent form programmed in REDCap®. If the participant consented to participate, they completed the self-directed web-based eligibility screener.

Pre-assignment details

If eligible, they transitioned immediately from the screening questions to the baseline survey. Following completion of the baseline survey, the participant was randomized to study condition using simple randomization procedures with stratification by biological sex.

Baseline characteristics

Characteristic
Age, Customized
18-25 years
24 Participants
Age, Customized
26-35 years
71 Participants
Age, Customized
36-45 years
81 Participants
Age, Customized
45-55 years
97 Participants
Age, Customized
56-65 years
63 Participants
Age, Customized
66-75 years
40 Participants
Age, Customized
76+ years
22 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
7 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
198 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
4 Participants
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants
Race (NIH/OMB)
Asian
4 Participants
Race (NIH/OMB)
Black or African American
25 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
9 Participants
Race (NIH/OMB)
White
317 Participants
Sex: Female, Male
Female
134 Participants
Sex: Female, Male
Male
70 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1880 / 210
other
Total, other adverse events
0 / 1880 / 210
serious
Total, serious adverse events
0 / 1880 / 210

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 23, 2026