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Clinical Trials in Sweden / NCT06084520
Recruiting Observational

Translation and Validation of the COMM and ASI-SR

NCT06084520 · tracked via the Priya Life Science Sweden tracker
Phase
Observational
Started
2023-12-01
Last updated
2024-05-10

Condition(s) studied

Opioid UseOpioid Use DisorderAlcohol Use DisorderPain, Chronic

Investigational drug(s) / intervention(s)

Current Opioid Misuse Measure (COMM)-SWEOral fluid drug testPEThASI-SRAUDITDUDITBrief Pain Inventory - BPIPatient Global Impression of Change PGICGAD-7Patient Health questionnaire (PHQ9)DBS - cannabis testSample of Blood for later DNA and immunological analysis in future studies

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.

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

PETh: Alcohol use detection

ASI-SR: Cross-validation form

AUDIT: Cross-validation form

DUDIT: Cross-validation form

Brief Pain Inventory - BPI: Cross-validation form

Patient Global Impression of Change PGIC: Cross-validation form

GAD-7: Cross-validation form

Patient Health questionnaire (PHQ9): Cross-validation form

DBS - cannabis test: cross-validation form

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

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: Intervention group: * Patients with long-term, non-cancer-related pain (\>3 months) at least 3 days a week * opioid treatment for at least 1 month during last 6 months * age 18-75 years * fluent in spoken and written Swedish. Control group: * Patients with long-term, non-cancer-related pain (\>3 months) at least 3 days a week * no opioid treatment at inclusion and during last 3 months * age 18-75 years * fluent in spoken and written Swedish Exclusion Criteria: * ongoing diseases or conditions that prevents the patient from completing to the study according to the doctor's assessment * serious cognitive disorder that makes answering the questions impossible. - - ongoing or treated cancer in the last 10 years * Insufficient knowledge of Swedish

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Multidisciplinary Pain Center Uppsala Uppland Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06084520 on ClinicalTrials.gov ↗ ← All trials in Sweden