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

NCT06288282 | Recruiting

• 1 other identifier: STUDY-23-01287
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Back Pain

Outcome Measures

Primary Outcomes (2)

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

  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.

  within 12 months

• Current Opioid misuse measure (COMM) surveys

  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.

  within 12 months

Secondary Outcomes (1)

• Pain Intensity with Brief Pain inventory (BPI)

  within 12 months

Study Arms (1)

Patients with chronic back pain with lumbar, cervical or thoracic spine diagnoses.

Other: No Intervention

Interventions

No Intervention OTHER

No intervention will be used.

Patients with chronic back pain with lumbar, cervical or thoracic spine diagnoses.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

chronic back pain

You may qualify if:

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

You may not qualify if:

• Cancer pain

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai Pain management centers

New York, New York, 10029, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

Study Officials

• Chinwe Nwaneshiudu

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chinwe Nwaneshiudu, MD PhD

CONTACT

212 241 4203; chinwe.nwaneshiudu@mountsinai.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: March 1, 2024
• Study Start: December 20, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose. For individual participant data meta-analysis. Proposals should be directed to chinwe.nwaneshiudu@mountsinai.org. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third-party website (TBD)

Locations

US (1)