Text Intervention to Facilitate Secure Storage and Disposal of Prescription Opioids

Opioid Misuse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05503186
• Other study ID #: IRB00102139
• Secondary ID: UMCIRB 21-001307
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Wake Forest University Health Sciences
• Contact: Kathleen Egan, PhD, MS
• Phone: 336-716-9354
• Email: klegan[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 360
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid Misuse
• Opioid-Related Disorders

Intervention

Other:
• Text Message
The intervention consists of a series of text messages aimed to facilitate secure storage and disposal of unused opioid medications.
• Standard of Care
Information provided by the physician and/or pharmacist.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	East Carolina University, University of Kentucky, University of North Carolina, Chapel Hill

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	45 days following enrollment
Primary	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.	45 days following enrollment