Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| UMCIRB 21-001307 | Other Identifier | UMC |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Kentucky | OTHER |
| University of North Carolina, Chapel Hill | OTHER |
| East Carolina University | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Text Message | Other | The intervention consists of a series of text messages aimed to facilitate secure storage and disposal of unused opioid medications. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kathleen Egan, PhD, MS | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40245386 | Derived | 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. |
Not provided
Not provided
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.
Not provided
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.
Not provided
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.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Text Message Intervention Study Condition | 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. |
| FG001 | Control Study Condition | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The analyzed sample (N=398) excluded participants who did not have outcome data.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Text Message Intervention Study Condition | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | We excluded participants who did not have outcome data. | Posted | Count of Participants | Participants | 45 days following enrollment |
|
through day 45
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Text Message Intervention Study Condition | 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. 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. |
Not provided
Not provided
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kathleen Egan | Wake Forest University School of Medicine | 704-355-2000 | kathleen.egan@wfusm.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 8, 2024 | Mar 6, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 9, 2024 | Jan 30, 2025 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Standard of Care | Other | Information provided by the physician and/or pharmacist. |
|
| BG001 | Control Study Condition | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Control Study Condition | 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. |
|
|
|
| Primary | 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. | We excluded participants who did not have outcome data and who used all of their opioid medication. | Posted | Count of Participants | Participants | 45 days following enrollment |
|
|
|
|
| 0 |
| 188 |
| 0 |
| 188 |
| 0 |
| 188 |
| EG001 | Control Study Condition | 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. Standard of Care: Information provided by the physician and/or pharmacist. | 0 | 210 | 0 | 210 | 0 | 210 |
Not provided
Not provided