POINT - Preventing an Opioid Epidemic in Norway: Focusing on Treatment of Chronic Pain (POINT)

April 12, 2023 updated by: Kine Gjesdal, Helse Stavanger HF

Preventing an Opioid Epidemic in Norway: Focusing on Treatment of Chronic Pain

The investigators do research on chronic pain treatment to minimize the risks associated with opioids.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The investigators know that patients suffering from chronic pain need good treatment. The use of opioids for chronic, non-cancer related pain may seem appropriate in the short term, but can often have negative consequences for both the individual and society in the long term.

Several factors-the escalating use of opioids to chronic pain patients, the increasing use of strong opioids in particular, and the increasing number of overdoses caused by prescription opioids-point to the start of an opioid epidemic in Norway.

Objectives The overall goal of the POINT project is to provide knowledge to optimize treatment of patients with chronic pain in order to avoid unnecessary escalation of opioid treatment, improve their quality of life and reduce the burden of disease.

In the long run our objective is to prevent the unwanted consequences of opioid treatment and improve patients' quality of life.

Ultimately, through this project the investigators hope to prevent an opioid epidemic in Norway.

To achieve the main goal, the investigators will focus on pain patients and their doctors, as increasing opioid use may occur through the patient-doctor interaction.

Methods

The project will develop and test a non-drug interventions that consist of an interdisciplinary group treatment .

Financing The Research Council of Norway

Cooperation St. Olavs Hospital

Stavanger Hospital Trust

City of Stavanger

National Institute of Public Health (FHI)

Alcohol and Drug Research Western Norway (KoRFor)

Foreningen for kroniske smertepasienter (FKS) Norwegian Forum of Disabled Peoples' Organizations (SAFO)

Cooperation with other projects Injury Prevention and Outcomes following Trauma

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Norway
      • Stavanger, Norway, 4010
        • Recruiting
        • Stavanger municipality
        • Contact:
          • kine gjesdal, phd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • non-malignant, chronic pain
  • Registered in Stavanger municipality
  • Consent to participation.
  • Age 18 - 67 years
  • Pain duration <10 years

Exclusion Criteria:

  • malignant pain condition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Point1
Receiving treatment
Behavioral: POINT1
Receiving treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Audit C at 12 Weeks
Time Frame: 12 weeks
Audit C
12 weeks
Change from baseline in Pain Scores on the Visual Analog Scale at 12 Weeks
Time Frame: 12 weeks
Visual Analog Scale
12 weeks
Change from baseline in Bergen Insomnia scale at 12 Weeks
Time Frame: 12 weeks
BIS
12 weeks
Change from baseline in Health-related quality of life at 12 Weeks
Time Frame: 12 weeks
HQ5D5L
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helse Stavanger HF

Collaborators

The Research Council of Norway

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

June 1, 2025

Study Registration Dates

First Submitted

February 8, 2023

First Submitted That Met QC Criteria

April 12, 2023

First Posted (Actual)

April 25, 2023

Study Record Updates

Last Update Posted (Actual)

April 25, 2023

Last Update Submitted That Met QC Criteria

April 12, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • POINTstavanger

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

2023

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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