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

Chronic Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06288282
• Other study ID #: STUDY-23-01287
• Status: Recruiting
• Start date: December 20, 2023
• Est. completion date: December 20, 2024

Study information

• Verified date: February 2024
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Chinwe Nwaneshiudu, MD PhD
• Phone: 212 241 4203
• Email: chinwe.nwaneshiudu[@]mountsinai.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: December 20, 2024
• Est. primary completion date: December 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• With diagnoses related to chronic lower back pain

• Age above 18yrs

• Non pregnant

Exclusion Criteria:

• Cancer pain

Related Conditions & MeSH terms

• Chronic Back Pain
• Chronic Pain
• Opioid-Related Disorders

Intervention

Other:
• No Intervention
No intervention will be used.

Locations

Country	Name	City	State
United States	Mount Sinai Pain management centers	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Pain Intensity with Brief Pain inventory (BPI)	The Brief Pain Inventory (BPI) pain intensity scale is a 0 to 10 numeric rating scale used to assess a patient's pain intensity, with 0 being no pain and 10 being pain as bad as you can imagine. Higher scores indicate higher pain intensity.	within 12 months