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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06288282
Enrollment
130
Registered
2024-03-01
Start date
2023-12-20
Completion date
2025-12-31
Last updated
2025-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Back Pain

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.

Interventions

OTHERNo Intervention

No intervention will be used.

Sponsors

Icahn School of Medicine at Mount Sinai
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* Cancer pain

Design outcomes

Primary

MeasureTime frameDescription
Screener and Opioid Assessment for patients with pain revised (SOAPPR)within 12 monthsRisk 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.
Current Opioid misuse measure (COMM) surveyswithin 12 monthsCurrent 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.

Secondary

MeasureTime frameDescription
Pain Intensity with Brief Pain inventory (BPI)within 12 monthsThe 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.

Countries

United States

Contacts

Primary ContactChinwe Nwaneshiudu, MD PhD
chinwe.nwaneshiudu@mountsinai.org212 241 4203

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026