Clinical trial NCT06285032: Decreasing Loneliness to Optimize Pain Care
Official title: Addressing Loneliness in Primary Care Patients on Chronic Opioids to Prevent Opioid Misuse
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Loneliness
Opioid Use
Keywords: Loneliness
Opioid use
Chronic pain
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2024-02-29
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* English-speaking
* On chronic opioids (defined as defined as 3 or more months receiving prescribed opioids \[functional definition is 3 or more opioid prescriptions each less than 21 days apart as per our prior studies\])
* With a score greater or equal to 6 on the UCLA Loneliness 3-item Scale
* Have a chronic pain diagnosis

Exclusion Criteria:

* Have cancer-related pain
* Are on palliative care or live in a controlled setting (i.e., assisted living, nursing home or inpatient treatment facility)
* Have an upcoming scheduled surgery
* Severe cognitive impairment or active psychosis

Primary outcomes:
measure: Opioid Misuse
timeFrame: Baseline, post-intervention (2 weeks after the completion of the intervention), and month 3 after completed intervention.
Secondary outcomes:
measure: Determine Functional Outcome
timeFrame: Baseline, post-intervention (2 weeks after the completion of the intervention), and month 3 after completed intervention.
Other outcomes:
measure: Loneliness
timeFrame: Baseline, post-intervention (2 weeks after the completion of the intervention), and month 3 after completed intervention.
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Sebastian Tong, MD
role: PRINCIPAL_INVESTIGATOR
References: