Risk Factors for Long-term Opioid Use | NCT04928131

Studies
Risk Factors for Long-term Opioid Use

NCT04928131

Sponsor

Stanford University

Status

Completed

Last Update Posted

Apr 14, 2022Actual

Enrollment

1,500,392Actual

Phase

Not provided

Conditions

Pain Syndrome

Interventions

No intervention - retrospective observational cohort study

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007Actual

Primary Completion Date

Sep 2015Actual

Completion Date

Feb 2021Actual

First Submitted Date

Jun 9, 2021

First Submission Date that Met QC Criteria

Jun 9, 2021

First Posted Date

Jun 16, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 7, 2022

Last Update Posted Date

Apr 14, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Surgeons often see patients with pain to exclude organic pathology and consider surgical treatment. We examined factors associated with long-term opioid therapy among patients with foot/ankle, anorectal, and temporomandibular joint pain to aid clinical decision making.

Using the IBM MarketScan® Research Database, we conducted a retrospective cohort analysis of patients aged 18-64 with a clinical encounter for foot/ankle, anorectal, or temporomandibular joint pain (January 2007-September 2015). Multivariable logistic regression was used to estimate adjusted odds ratios for factors associated with long-term opioid therapy, including age, sex, geographic region, pain condition, psychiatric diagnoses, and surgical procedures in the previous year.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,500,392Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Anorectal	Patients presenting with anorectal pain.	Other: No intervention - retrospective observational cohort study
TMJ	Patients presenting with temporomandibular joint pain.	Other: No intervention - retrospective observational cohort study
Foot/Ankle	Patients presenting with foot and ankle pain.	Other: No intervention - retrospective observational cohort study

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention - retrospective observational cohort study	Other		Anorectal Foot/Ankle TMJ

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Long-term opioid use	opioid prescriptions for 3 months.	>90 days of opioid supply

Secondary Outcomes

Measure	Description	Time Frame
new long-term opioid use	Opioid prescriptions for over 3 months in patients who have not had prior opioid prescriptions.	>90 days of opioid supply

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18-64 years old
at least one encounter for anorectal, foot/ankle, or TMJ pain
Marketscan continuous enrollment for 1 year prior and 1 year after the index pain encounter

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

adult patients enrolled in private health insurance included within the Marketscan database, who generated at least one insurance claim for anorectal, foot/ankle, or TMJ pain.

Sampling Method

Non-Probability Sample