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

Sponsor

Helse Stavanger HF (Other)

Overall Status

Recruiting

CT.gov ID

NCT05828121

Collaborator

The Research Council of Norway (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain Opioid Use	Behavioral: POINT1	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

N/A

Intervention Model:

Sequential Assignment

Intervention Model Description:

MRC framework for a complex interventionMRC framework for a complex intervention

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jun 1, 2025

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Point1

Receiving treatment

Behavioral: POINT1

Receiving treatment

Outcome Measures

Primary Outcome Measures

Change From Baseline in Audit C at 12 Weeks [12 weeks]
Audit C
Change from baseline in Pain Scores on the Visual Analog Scale at 12 Weeks [12 weeks]
Visual Analog Scale
Change from baseline in Bergen Insomnia scale at 12 Weeks [12 weeks]
BIS
Change from baseline in Health-related quality of life at 12 Weeks [12 weeks]
HQ5D5L

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 67 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stavanger municipality	Stavanger		Norway	4010

Sponsors and Collaborators

Helse Stavanger HF
The Research Council of Norway

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kine Gjesdal, Associate professor, Helse Stavanger HF

ClinicalTrials.gov Identifier:

NCT05828121

Other Study ID Numbers:

POINTstavanger

First Posted:

Apr 25, 2023

Last Update Posted:

Apr 25, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Chronic Pain

Study Results

No Results Posted as of Apr 25, 2023