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Text Intervention to Facilitate Secure Storage and Disposal of Prescription Opioids

Primary Purpose

Opioid Misuse

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Text Message
Pamphlet
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Opioid Misuse

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Text Message Intervention Study Condition

    Control Study Condition

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 12, 2022
    Last Updated
    October 20, 2023
    Sponsor
    Wake Forest University Health Sciences
    Collaborators
    University of Kentucky, University of North Carolina, Chapel Hill
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05503186
    Brief Title
    Text Intervention to Facilitate Secure Storage and Disposal of Prescription Opioids
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2023 (Anticipated)
    Primary Completion Date
    June 1, 2024 (Anticipated)
    Study Completion Date
    July 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Wake Forest University Health Sciences
    Collaborators
    University of Kentucky, University of North Carolina, Chapel Hill

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Opioid Misuse

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    360 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Text Message Intervention Study Condition
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control Study Condition
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Text Message
    Intervention Description
    The intervention consists of a series of text messages aimed to facilitate secure storage and disposal of unused opioid medications.
    Intervention Type
    Other
    Intervention Name(s)
    Pamphlet
    Intervention Description
    Informational pamphlet with guidance on secure storage and disposal of prescription opioids.
    Primary Outcome Measure Information:
    Title
    Proportion of participants who securely stored their opioid medication during treatment
    Description
    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.
    Time Frame
    30 days following enrollment
    Title
    Proportion of participants who disposed of their unused opioid medication
    Description
    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.
    Time Frame
    30 days following enrollment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kathleen Egan, PhD, MS
    Phone
    252-328-2710
    Email
    eganlab@ecu.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kathleen Egan, PhD, MS
    Organizational Affiliation
    East Carolina University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    After all data have been collected and the results of the study have been published, de-identified data will be made available to other qualified investigators upon request. The request will be evaluated by the Principal Investigator to ensure that it meets reasonable demands of scientific inquiry. Data collected for this study will be submitted and shared with the National Institute on Drug Abuse Data Archive per NOT-OD-03-032.
    IPD Sharing Time Frame
    After all data have been collected and the results of the study have been published.
    IPD Sharing Access Criteria
    De-identified data will be made available to other qualified investigators upon request. The request will be evaluated by the Principal Investigator to ensure that it meets reasonable demands of scientific inquiry. Data collected for this study will be submitted and shared with the National Institute on Drug Abuse Data Archive per NOT-OD-03-032.

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    Text Intervention to Facilitate Secure Storage and Disposal of Prescription Opioids

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