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RECRUITING
NCT06084520

Translation and Validation of the COMM and ASI-SR

Sponsor: Uppsala University

View on ClinicalTrials.gov

Summary

The goal of this observational study is to translate the COMM (Current opinion misuse measure) form and validate it using the ASI-SR (Addiction severity score-self report)in a Swedish population of pain patients treated with opioids. The secondary aim is to investigate acceptability of the instrument in a Swedish population of pain patients with long-term opioid treatment (LOT). The tertiary aim is to investigate the prevalence of alcohol and illicit substance use in a Swedish population of pain patients with LOT.

Official title: Translation and Validation of the COMM and ASI-SR - Instruments for Assessing Substance Use Disorder Development in a Swedish Population of Patients With Long-term Pain Treated With Opioids

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

400

Start Date

2023-12-01

Completion Date

2026-12-31

Last Updated

2024-05-10

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Current Opioid Misuse Measure (COMM)-SWE

Patients in test group should fulfill the the COMM and the battery of validation forms as well as leave the oral fluid for illicit drugs test and whole blod for phosphatidylethanol test.

DIAGNOSTIC_TEST

Oral fluid drug test

Oral fluid sampling to detect drugs. Analysis with LC-HRMS

DIAGNOSTIC_TEST

PETh

Alcohol use detection

DIAGNOSTIC_TEST

ASI-SR

Cross-validation form

DIAGNOSTIC_TEST

AUDIT

Cross-validation form

DIAGNOSTIC_TEST

DUDIT

Cross-validation form

DIAGNOSTIC_TEST

Brief Pain Inventory - BPI

Cross-validation form

DIAGNOSTIC_TEST

Patient Global Impression of Change PGIC

Cross-validation form

DIAGNOSTIC_TEST

GAD-7

Cross-validation form

DIAGNOSTIC_TEST

Patient Health questionnaire (PHQ9)

Cross-validation form

DIAGNOSTIC_TEST

DBS - cannabis test

cross-validation form

OTHER

Sample of Blood for later DNA and immunological analysis in future studies

sample collection for future studies

Locations (1)

Multidisciplinary Pain Center

Uppsala, Uppland, Sweden