Translation and Validation of the COMM and ASI-SR

NCT06084520 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2024-05-10

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • The Kamprad Family Foundation for Entrepreneurship, Research & Charity

    collaborator OTHER
  • Uppsala University

    lead OTHER

Principal Investigators

  • Rolf Karlsten, PhD · Uppsala University

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • Sweden

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06084520 on ClinicalTrials.gov