NCT06063902

Brief Summary

The study investigates long-term opioid treatment in patients with chronic non-cancer pain (CNCP). The study aims to prospectively identify predictive factors for work ability and for developing opioid use disorder (according to DSM-5) as well as predictive factors for pain, activity, and health-related quality of life. It is hypothesized that certain biopsychosocial factors mapped in this study predict patterns of opioid use and the risk for developing OUD for patients with CNCP on long-term opioid therapy. Further, it is hypothesized that certain biopsychosocial factors mapped in this study predict the chance of improved work ability and other treatment benefits of long term opioid therapy in patients with CNCP.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Study Progress91%
Jan 2019Jan 2027

Study Start

First participant enrolled

January 14, 2019

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2023

Completed
9 months until next milestone

First Posted

Study publicly available on registry

October 3, 2023

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2027

Last Updated

October 3, 2023

Status Verified

September 1, 2023

Enrollment Period

8 years

First QC Date

January 12, 2023

Last Update Submit

September 25, 2023

Conditions

Chronic Non-Cancer PainOpioid Use Disorder

Keywords

Chronic painChronic primary painAnalgesicsOpioidOpioid-use disorderWork AbilityHealth-related quality of lifeOpioid-related risk behaviorPainActivityOpioid-related complications

Outcome Measures

Primary Outcomes (2)

  • Characterization and changes in opioid use disorder

    As defined in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Measured by: Structured interview: Modified version of the Swedish Mini International Neuropsychiatric Interview, Part J (Substance use). Response format yes/no. Mild opioid use disorder = 2-3 symptoms Moderate opioid use disorder = 4-5 symptoms Severe opioid use disorder = 6 or more symptoms

    Baseline, 1 year, 2 years, 3 years, 4 years, 5 years

  • Changes in work ability

    Self report. Work Ability Index (WAI). The questionnaire covers 7 dimensions: 1. current work ability compared with lifetime best 2. work ability in relation to the demands of the job 3. number of diagnosed illnesses or limiting conditions 4. estimated impairment owing to diseases/illnesses or limiting conditions 5. amount of sick leave during the last year 6. prognosis of work ability in 2 years' time 7. psychological resources. The dimensions have different scores. A total index is computed ranging from 7 to 49, where higher scores indicate higher work ability. Individual items or sub-scales of WAI may also be used as outcome measures.

    Baseline, 1 year, 2 years, 3 years, 4 years, 5 years

Secondary Outcomes (26)

  • Changes and patterns of opioid use (type of opioid, dose, and duration)

    Baseline, 1 year, 2 years, 3 years, 4 years, 5 years

  • Changes in pain severity and pain interference: The Brief Pain Inventory short-form (BPI-SF)

    Baseline, 1 year, 2 years, 3 years, 4 years, 5 years

  • Changes in health related quality of life: EQ-5D-5L

    Baseline, 1 year, 2 years, 3 years, 4 years, 5 years

  • Depressive symptoms

    Baseline

  • Generalised Anxiety Disorder

    Baseline

  • +21 more secondary outcomes

Other Outcomes (12)

  • Sick-leave

    Baseline

  • Sick-leave

    1 year

  • Sick-leave

    2 year

  • +9 more other outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with moderate to severe CNCP referred to secondary and tertiary pain care at the Uppsala University Hospital.

You may qualify if:

  • Referral for a first visit to the Pain Centre of Uppsala University Hospital. The following
  • Competent in Swedish
  • Chronic Non-Cancer Pain (pain \> 90 days)

You may not qualify if:

  • In active cancer treatment/Cancer-related pain
  • In palliative care
  • Need for interpreter
  • Cognitive impairment of magnitude that will prevent completion of study or ability to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uppsala Univeristy Hospital

Uppsala, Sweden

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample

MeSH Terms

Conditions

Opioid-Related DisordersChronic PainPainMotor Activity

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Pernilla Åsenlöf, Professor

    Uppsala University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2023

First Posted

October 3, 2023

Study Start

January 14, 2019

Primary Completion (Estimated)

January 14, 2027

Study Completion (Estimated)

January 14, 2027

Last Updated

October 3, 2023

Record last verified: 2023-09

Locations

SE(1)