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Clinical Trials/NCT06288282
NCT06288282RecruitingNot Applicable

Behavioral and Cognitive Predictors of Persistent Pain and Opioid Misuse in Chronic Pain

Icahn School of Medicine at Mount Sinai1 site in 1 country130 target enrollmentStarted: December 20, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
130
Locations
1
Primary Endpoint
Current Opioid misuse measure (COMM) surveys

Study Overview

Brief Summary

Chronic lower back pain (CLBP) affects approximately 20% of the global population. The study objective is to determine if impulsivity, inhibitory control, drug choice, and/or cognitive distortions predict opioid misuse and disability in patients with chronic pain. This is a prospective consented cross-sectional study characterizing behavioral and cognitive phenotypes using both patient-reported survey measures and cognitive testing. Outcome measures include correlations between impulsivity measures, opioid drug choice responses and cognitive distortion scores, and risk for opioid misuse (Primary outcomes: COMM scores, SOAPPR scores). Secondary outcomes is BPI measurement. A Certificate of Confidentiality will provide additional protections for participants.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • With diagnoses related to chronic lower back pain
  • Age above 18yrs
  • Non pregnant

Exclusion Criteria

  • Cancer pain

Outcomes

Primary Outcomes

Current Opioid misuse measure (COMM) surveys

Time Frame: within 12 months

Current opioid misuse measures with the Current Opioid misuse measure (COMM) surveys. The COMM is a 17-item self-report measure with total scores ranging from 0 to 68 that is used to identify risk of opioid misuse among chronic pain patients, with higher scores indicating higher risk of opioid misuse.

Screener and Opioid Assessment for patients with pain revised (SOAPPR)

Time Frame: within 12 months

Risk of opioid misuse with the Screener and Opioid Assessment for Patients with Pain Revised (SOAPPR). The Screener and Opioid Assessment for Patients with Pain-Revised (SOAPP-R) is a 24-item self-report questionnaire with total scores ranging from 0 to 24 that is used to predict risk of aberrant medication-related behaviors among chronic pain patients, with higher scores indicating higher risk of aberrant behaviors.

Secondary Outcomes

  • Pain Intensity with Brief Pain inventory (BPI)(within 12 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Chinwe Nwaneshiudu

Assistant Professor

Icahn School of Medicine at Mount Sinai

Study Sites (1)

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