NCT05503186

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
479

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 16, 2022

Completed
1.8 years until next milestone

Study Start

First participant enrolled

June 14, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2024

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

March 27, 2026

Completed
Last Updated

April 22, 2026

Status Verified

April 1, 2024

Enrollment Period

6 months

First QC Date

April 12, 2022

Results QC Date

March 6, 2026

Last Update Submit

April 2, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Percentage of Participants Who Securely Stored Their Opioid Medication During Treatment

    Investigators 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.

    45 days following enrollment

  • Percentage of Participants Who Disposed of Their Unused Opioid Medication

    Investigators 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.

    45 days following enrollment

Study Arms (2)

Text Message Intervention Study Condition

EXPERIMENTAL

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.

Other: Text MessageOther: Standard of Care

Control Study Condition

ACTIVE COMPARATOR

Participants assigned to the control study condition will not receive the text message intervention. Participants assigned to the control study condition will receive a standard of care of treatment which is whatever guidance that is provided to them by their physician and/or pharmacist.

Other: Standard of Care

Interventions

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

Text Message Intervention Study Condition

Information provided by the physician and/or pharmacist.

Control Study ConditionText Message Intervention Study Condition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (1)

  • Egan KL, Cox MJ, Helme DW, Jackson JT, Richman AR. Text Message Intervention to Facilitate Secure Storage and Disposal of Prescription Opioids to Prevent Diversion and Misuse: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Apr 17;14:e60332. doi: 10.2196/60332.

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Limitations and Caveats

Limitations include eligibility within 14 days of opioid prescription, restricting findings to short-term therapy. Messaging exposure outside the intervention was uncontrolled. Message delivery was confirmed, but reading rates were unknown. Self-reported surveys may have social desirability bias. Election-related text volume could reduce engagement.

Results Point of Contact

Title
Dr. Kathleen Egan
Organization
Wake Forest University School of Medicine

Study Officials

  • Kathleen Egan, PhD, MS

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2022

First Posted

August 16, 2022

Study Start

June 14, 2024

Primary Completion

December 9, 2024

Study Completion

December 9, 2024

Last Updated

April 22, 2026

Results First Posted

March 27, 2026

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will share

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.

Time Frame
After all data have been collected and the results of the study have been published.
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.

Locations