Translation and Validation of the COMM and ASI-SR
COMMISS
1 other identifier
observational
400
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2023
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 21, 2023
CompletedFirst Posted
Study publicly available on registry
October 16, 2023
CompletedStudy Start
First participant enrolled
December 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
ExpectedMay 10, 2024
May 1, 2024
2.1 years
July 21, 2023
May 8, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
COMM - Current opioid misuse version Swedish version
COMM is based on 17 questions, all of which are answered on a 5-point Likert scale. As the original COMM instrument has identified 5 categories of questions, each area will be assessed against the following instruments: 1. Symptoms and signs of drug abuse (question 1) - AUDIT, DUDIT, ASI-SR, drug and alcohol test 2. Emotional and psychiatric problems (questions 2,5,7,8,13) - ASI-SR, GAD-7, PHQ9 3. Visitor characteristics/patterns (questions 3,12,17) - medical record data 4. Occurrence of untrue statement (doubt/lie/untruth) and drug use (questions 4,6,9,10,11) - medical record data, drug and alcohol tests
Baseline
Secondary Outcomes (11)
ASI-SR Addiction severity index - short release
Baseline
COMM - 2nd test
1 week after baseline
AUDIT Alcohol Use Disorder Identification Test
Baseline
BPI-Brief Pain Inventory - short form
Baseline
Patient global impression of change - PGI-C
Baseline
- +6 more secondary outcomes
Other Outcomes (1)
Descriptive characteristics of the group
baseline
Study Arms (2)
Test group - patients with chronic pain treated with opioids
Patients with long-term, non-cancer-related pain (\>3 months) at least 3 days a week, age 18-75 years, who have been treated with opioids for at least 1 month and who can speak, read and write in Swedish, recruited within Uppsala County Primary, Secondary and Tertiary Care.
Control group - patients with chronic pain not-treated with opioids
Patients with long-term, non-cancer-related pain (\>3 months) at least 3 days a week, age 18-75 years, who are not treated with opioids (at inclusion and during the last 3 months) and who can speak, read and write in Swedish, recruited within Uppsala County Primary, Secondary and Tertiary Care.
Interventions
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 sampling to detect drugs. Analysis with LC-HRMS
Alcohol use detection
Cross-validation form
Cross-validation form
Cross-validation form
Cross-validation form
Cross-validation form
Cross-validation form
Cross-validation form
cross-validation form
sample collection for future studies
Eligibility Criteria
Chronic pain patients (18-75 years old) within Uppsala County treated both in Primary care, Secondary care ( Endometrios center) and Tertiary care ( Pain and Addiction clinic)
You may qualify if:
- 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
- age 18-75 years
- fluent in spoken and written Swedish
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Multidisciplinary Pain Center
Uppsala, Uppland, 75185, Sweden
Biospecimen
Whole blood and serum for genetic analysis sampling, but not analysed for the purpose of this study. Blood samples for PETH analysis. Dry Blood spott for cannabis analysis.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rolf Karlsten, PhD
Uppsala University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2023
First Posted
October 16, 2023
Study Start
December 1, 2023
Primary Completion
December 31, 2025
Study Completion (Estimated)
December 31, 2026
Last Updated
May 10, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share