Opioid-Related DisordersNCT05577026
Safe Prescription of Opioids in Primary Care
A study testing Educational intervention and prescription feedback and General information on treatment guidelines in people with Opioid-Related Disorders and Narcotic-Related Disorders, run by Region Stockholm at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid-Related Disorders, Narcotic-Related Disorders, Addiction
- What is being tested?
- Educational intervention and prescription feedback and General information on treatment guidelines
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSweden
- Study dates
- 9 Feb 2023to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- In operation for less than 12 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Educational intervention and prescription feedback, General information on treatment guidelines
- Keywords
- Early Intervention, Educational, Prescription Drugs, Opioids, Primary Health Care
- Medical subject headings
- Opioid-Related Disorders, Narcotic-Related Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational intervention and prescription feedbackBehavioural
Brief educational intervention and patient and provider materials regarding prescription of opioids. Subsequent feedback on clinic prescription of opioids over 12 months.
General information on treatment guidelinesBehavioural
Written information on guidelines and recommendations regarding prescription of opioids.
| Study group | Role | What they receive |
|---|---|---|
| Educational intervention with prescription feedback | Experimental | 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. Receives: Behavioral: Educational intervention and prescription feedback |
| Written information on guidelines | Active comparator | 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. Receives: Behavioral: General information on treatment guidelines |
| Standard care | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Change in opioid prescriptions
Change in prescription of opioids as measured by defined daily dose (DDD) and morphine milligram equivalents (MME)
Measured: 12 months
Secondary outcomes (2)
Change in opioid types
Change in type of opioids prescribed by drug class (ATC code)
Measured: 12 months
Change in opioid prescriptions
Change in prescriptions of opioids as measured by defined daily dose (DDD) and morphine milligram equivalents (MME)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start9 Feb 2023
- Primary completion3 Mar 2025
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid-Related DisordersStudies of the same condition, open and under way.
- More trials run by Region StockholmThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Johan Franck, MD, PhD, Principal investigator, Region Stockholm / SLSO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05577026
- Sponsor's protocol ID
- Smartaval2022-01
- Status last verified
- Aug 2025
- First submitted
- 4 Oct 2022
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Kruger C, Franck J, Hallgren J, Af Winklerfelt Hammarberg S, Norman C, Niper A, Westman J. Improved opioid prescribing in primary care: protocol for a cluster randomised pragmatic trial. BMJ Open. 2025 Dec 17;15(12):e110818. doi: 10.1136/bmjopen-2025-110818.
PubMed 41407431
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safe and Appropriate Prescribing of Opioids in Primary Care: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05577026
- Acronym / sponsor ID
- Smartaval2022-01
- Keywords
- Early Intervention, Educational, Prescription Drugs, Opioids, Primary Health Care
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Region StockholmOther government
- Study start
- 9 Feb 2023 (actual)
- Primary completion
- 3 Mar 2025 (actual)
- Study completion
- Mar 2027 (estimated)
- First posted
- 13 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Educational intervention with prescription feedback | Experimental | Behavioral: Educational intervention and prescription feedbackHealthcare 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. |
| Written information on guidelines | Active comparator | Behavioral: General information on treatment guidelinesThe 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. |
| Standard care | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (1 listed)
- In operation for less than 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational intervention and prescription feedbackBrief educational intervention and patient and provider materials regarding prescription of opioids. Subsequent feedback on clinic prescription of opioids over 12 months. | Behavioural | Educational intervention with prescription feedback |
| General information on treatment guidelinesWritten information on guidelines and recommendations regarding prescription of opioids. | Behavioural | Written information on guidelines |
Primary outcome
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)
2 secondary outcomes
Change in opioid types
Time frame: 12 months
Change in opioid prescriptions
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Derived from this study: PubMed 41407431Kruger C, Franck J, Hallgren J, Af Winklerfelt Hammarberg S, Norman C, Niper A, Westman J. Improved opioid prescribing in primary care: protocol for a cluster randomised pragmatic trial. BMJ Open. 2025 Dec 17;15(12):e110818. doi: 10.1136/bmjopen-2025-110818.
- Individual participant dataSharing planned: No. 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.
Related trials for Opioid-Related Disorders
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Active, not recruitingPhase 2
Wellcome Leap Psilocybin for OUD
Opioid Use Disorder
Recruiting
Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial
Opioid Use Disorder, Opioid Misuse
Active, not recruiting
EXHIT ENTRE Implementation Trial of High Intensity Versus Low Intensity Strategy
Substance Use Disorders, Opioid Use Disorder, Severe
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johan Franck, MD, PhD principal investigator
Region Stockholm / SLSO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational intervention and prescription feedback and General information on treatment guidelines in people with Opioid-Related Disorders and Narcotic-Related Disorders, run by Region Stockholm at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in opioid prescriptions (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05577026, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.