Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2025-12-25 @ 7:27 PM
Study NCT ID:
NCT06285032
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-15
First Post:
2024-02-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Decreasing Loneliness to Optimize Pain Care
Sponsor:
University of Washington
Organization:
Study Overview
Official Title:
Addressing Loneliness in Primary Care Patients on Chronic Opioids to Prevent Opioid Misuse
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DLoop
Brief Summary:
Loneliness, which is the perceived feeling of insufficient personal relationships, is related to higher risk for inappropriate opioid use and opioid use disorders in patients who are taking opioids long-term. The study seeks to pilot test the evidence-based loneliness interventions of psychological therapy and social navigation in patients on chronic opioids treated in primary care practices to determine if reducing loneliness can lower opioid misuse.
Detailed Description:
Patients with chronic pain on opioids frequently experience loneliness, which is associated with poorer health outcomes and higher risks for opioid misuse and opioid use disorder. Given that almost half of opioids are prescribed in primary care, a critical need exists for the development and testing of interventions to reduce loneliness in primary care patients at risk for opioid misuse. The long-term goal of the study is to reduce opioid misuse and opioid use disorder by addressing loneliness in primary care with patients on chronic opioids. Interventions addressing maladaptive social cognition through cognitive behavioral therapy and improving social support through social navigation have been shown to be effective in reducing loneliness and improving outcomes in other fields but have not been tested in patients at risk for substance use disorder.
Aims
* To refine both the social navigation and psychological CBT loneliness interventions for patients in primary care on chronic opioids
* To assess the feasibility of implementing a 3-arm pilot randomized clinical effectiveness trial testing a psychological CBT and a social navigation intervention to address loneliness in primary care patients.
* To determine the distribution and variability in the mediating outcome (loneliness), the primary outcome (opioid misuse) and secondary outcomes, including opioid dose, functional status and patient-reported pain outcomes in the pilot randomized clinical effectiveness trial.
Aims
* To refine both the social navigation and psychological CBT loneliness interventions for patients in primary care on chronic opioids
* To assess the feasibility of implementing a 3-arm pilot randomized clinical effectiveness trial testing a psychological CBT and a social navigation intervention to address loneliness in primary care patients.
* To determine the distribution and variability in the mediating outcome (loneliness), the primary outcome (opioid misuse) and secondary outcomes, including opioid dose, functional status and patient-reported pain outcomes in the pilot randomized clinical effectiveness trial.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R34DA058325 | NIH | None | https://reporter.nih.gov/quic… | View |