Safe Prescription of Opioids in Primary Care

February 17, 2026 updated by: Region Stockholm

Safe and Appropriate Prescribing of Opioids in Primary Care: a Randomized Control Trial

Opioid analgesics are commonly prescribed addictive narcotics intended for the treatment of pain. Inappropriate prescription of opioids in quantities and for conditions which lack clinical evidence contributes to the risk of misuse and addiction. The majority of opioid prescriptions are written by physicians (general practitioners) in primary health care (PHC). PHC is thus an important setting for efforts to encourage the safe and appropriate prescription of opioids. Increasing knowledge of pain treatment recommendations, risks of opioids, and guidelines for the prescription of opioids may decrease inappropriate prescription, and thereby risk of tolerance, dependence, and addiction.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Opioids are a class of addictive narcotic drugs which can be obtained by prescription for the treatment of pain. There is clinical evidence for the use of opioids for acute, post-operative, and cancer related pain, although guidelines recommend the lowest effective dose and duration be prescribed. There is less evidence for the long-term benefits of opioid therapy for chronic non-cancer pain and the risk for harm and addiction is increased with prolonged use. Patients with long-term treatment may experience only marginal pain reduction and a risk of long-term consequences including tolerance, dependence, and adverse effects such as cognitive disturbance and decline, behavioral problems, emergency visits, accidents, suicide, and drug-related mortality. As the majority of opioids are prescribed by physicians in primary health care, this is an important setting for promoting the safe and appropriate use of prescription opioids.

This trial evaluates whether a brief educational intervention in primary health care (PHC) followed by 12 months of feedback on prescription data changes the prescription of opioids in primary care.

PHC centers in Stockholm County will be invited to participate in the study. Centers that express interest in participating, meet the inclusion criteria, and do not meet the exclusion criteria will be randomized to the intervention or control group. Personnel at the intervention centers will participate in a brief educational intervention followed by 12 months of regular feedback on opioid prescriptions, with benchmarking to other local PHC centers. Centers randomized to the active control group will receive written information on treatment guidelines but will not receive the onsite educational intervention or prescription feedback.

The primary outcome, change in opioid prescription, will be measured at 12 months after intervention start. Data on outcomes and characteristics of participating primary health care centers including prescription before, during and after the intervention will be extracted from regional health care registers and databases and analyzed statistically.

Study Type

Interventional

Enrollment (Actual)

52

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 Locations

  • Sweden
      • Stockholm, Sweden, 113 65
        • Akademiskt Primärvårdscentrum, Solnavägen 1D

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Eligibility criteria apply to primary health care centers.

Inclusion Criteria:

  • Employs at least two full-time physicians
  • Has at least 3000 listed patients
  • Has a regional care agreement (contract)
  • Connected to the regional quality register (Stockholm County)

Exclusion Criteria:

  • In operation for less than 12 months

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Educational intervention with prescription feedback
Healthcare personnel will participate in a brief educational intervention with information regarding treatment guidelines, recommendations, and risks of prescribing opioids. The presentation will include benchmarking on clinic opioid prescription patterns compared to other primary health centers, followed by targeted feedback on prescription patterns over the subsequent 12 months. Standardized materials will be provided, including a patient-provider agreement, outline of a patient treatment plan, and recommendations of how shared routines at the center can be improved.
Behavioral: Educational intervention and prescription feedback
Brief educational intervention and patient and provider materials regarding prescription of opioids. Subsequent feedback on clinic prescription of opioids over 12 months.
Active Comparator: Written information on guidelines
The manager at each PHC center in the active control group will receive written information on treatment guidelines for pain management. These centers will not receive the intervention, consisting of the onsite educational visit and targeted prescription feedback.
Behavioral: General information on treatment guidelines
Written information on guidelines and recommendations regarding prescription of opioids.
No Intervention: Standard care
The passive control group will consist of PHC centers that met the eligibility criteria for the study but did not actively participate in the study. Care as usual will proceed at the centers. Prescription data will be gathered directly from regional registers and databases; thus there will be no need to communicate directly with the centers. This arm will be used only if the General Data Protection Regulation continues to allow access to regional registers and databases in primary health care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in opioid prescriptions
Time Frame: 12 months
Change in prescription of opioids as measured by defined daily dose (DDD) and morphine milligram equivalents (MME)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in opioid types
Time Frame: 12 months
Change in type of opioids prescribed by drug class (ATC code)
12 months
Change in opioid prescriptions
Time Frame: 24 months
Change in prescriptions of opioids as measured by defined daily dose (DDD) and morphine milligram equivalents (MME)
24 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in number of patients with opioid prescriptions
Time Frame: 12 months
Change in number of patients prescribed opioids (new or continued prescription)
12 months
Change in initial opioid prescriptions
Time Frame: 12 months
Change in number of patients with initial (new) opioid prescriptions among opioid-naïve patients
12 months

Collaborators and Investigators

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

Sponsor

Region Stockholm

Investigators

  • Principal Investigator: Johan Franck, MD, PhD, Region Stockholm / SLSO

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

February 9, 2023

Primary Completion (Actual)

March 3, 2025

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

October 4, 2022

First Submitted That Met QC Criteria

October 10, 2022

First Posted (Actual)

October 13, 2022

Study Record Updates

Last Update Posted (Actual)

February 19, 2026

Last Update Submitted That Met QC Criteria

February 17, 2026

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Smartaval2022-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data for this study will be gathered from regional registers and health care databases. For permission to access these data, interested parties should contact Region Stockholm.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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