Opioid PrescribingNCT06443385
E-mails to Nudge Safer and Better-Informed Prescribing of Risky Drugs
A study testing PDMP Legal Mandate E-mail and PDMP Clinical Benefit E-mail in people with Opioid Prescribing and Prescription Drug Misuse, run by Columbia University at 1 site in United States.
Trial summary
This study will test e-mails to encourage engagement with the Minnesota prescription monitoring program (PMP/PDMP) and will evaluate the effect of these e-mails on PMP/PDMP use and controlled substance prescribing. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Opioid Prescribing, Prescription Drug Misuse
- What is being tested?
- PDMP Legal Mandate E-mail and PDMP Clinical Benefit E-mail
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,872 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2024to 24 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Minnesota physician or physician assistant
- Controlled substance prescriber not following state requirements to maintain an active PDMP account, or opioid prescriber not searching the PDMP or infrequently searching the PDMP
Who cannot join
- No e-mail address available
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
This study will test e-mails to encourage engagement with the Minnesota prescription monitoring program (PMP/PDMP) and will evaluate the effect of these e-mails on PMP/PDMP use and controlled substance prescribing.
Read the detailed description
Drug overdose deaths have skyrocketed in recent years, and many overdoses continue to involve prescribed medications like opioids and stimulants. At the same time, state prescription drug monitoring programs (PDMPs), which help clinicians prescribe these medications safely, remain underused. In Minnesota, 32% of opioid prescriptions are written by clinicians who do not use the PDMP. In many states, including Minnesota, policymakers have limited tools to raise PDMP use even though it is often required under state law. To address this policy dilemma, this study will test e-mails designed to facilitate PDMP use and evaluate their effects on PDMP use and controlled substance prescribing. This study will include a projected 7,126 physician and physician assistant prescribers of opioids and other controlled substances who lack active PDMP accounts, never query the PDMP, or query the PDMP infrequently relative to their prescribing volume. To generate evidence on clinician motivation for responding to encouragement, the study will randomly vary messaging to focus on legal requirements to use the PDMP vs. clinical benefits of the PDMP.
- Conditions
- Opioid Prescribing, Prescription Drug Misuse
- Being tested
- PDMP Legal Mandate E-mail, PDMP Clinical Benefit E-mail
- Keywords
- opioids, prescribing, overprescribing, prescription drug monitoring programs, controlled substances
- Medical subject headings
- Prescription Drug Misuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PDMP Legal Mandate E-mailBehavioural
E-mails highlighting the state's legal requirements to use the PDMP. There will be one initial email and one follow-up email one month later.
PDMP Clinical Benefit E-mailBehavioural
E-mails highlighting the clinical benefits of having access to the PDMP and checking the PDMP before prescribing opioids. There will be one initial email and one follow-up email one month later.
| Study group | Role | What they receive |
|---|---|---|
| Legal Mandate Messaging | Experimental | Not described Receives: Behavioral: PDMP Legal Mandate E-mail |
| Clinical Benefit Messaging | Experimental | Not described Receives: Behavioral: PDMP Clinical Benefit E-mail |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of PDMP Engagement
An indicator for increased PDMP engagement during the 2-month period after the first e-mails were sent. It will indicate whether the level of engagement rose from the baseline level that resulted in the clinician's enrollment into the study. For clinicians who lacked an account, the outcome will indicate whether they created one; for clinicians with an inactive account, the outcome will indicate whether they reactivated it. For those who never searched, it will indicate any search, and for those who rarely searched, it will indicate whether their search rate rose.
Measured: 2 months
Volume of Potentially Guideline-discordant Opioid Prescribing
A composite of several measures of potentially guideline-discordant opioid prescribing. These will include:
- Opioid co-prescriptions with other opioids
- Opioid co-prescriptions with benzodiazepines
- Opioid co-prescriptions with gabapentinoids
- High daily opioid doses
- Long-duration opioid prescriptions to opioid-naïve individuals
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start17 Jul 2024
- Primary completion14 Sep 2024
- Study completion24 Sep 2025
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 PrescribingStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Clinicians will be assigned at random to one of three arms: PDMP legal mandate e-mails, PDMP clinical benefit emails, or a control group.
- Masking
- None (open label)
- Enrolment
- 7,872 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern California, Bowdoin College, Abdul Latif Jameel Poverty Action Lab, Minnesota Management and Budget, Minnesota Board of Pharmacy
- Responsible party
- Principal investigator, Adam Sacarny, PhD, Columbia University
- Investigators
- Adam Sacarny, PhD, Principal investigator, Columbia UniversityMireille Jacobson, PhD, Principal investigator, University of Southern CaliforniaTatyana Avilova, PhD, Principal investigator, Bowdoin College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06443385
- Sponsor's protocol ID
- AAAV1928
- Other IDs
- AEARCTR-0013549
- Status last verified
- Feb 2026
- First submitted
- 30 May 2024
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sacarny A, Avilova T, Williamson I, Merrick W, Jacobson M. Prescription Drug Monitoring Program Reminder Emails, Program Use, and Prescribing: A Randomized Clinical Trial. JAMA Health Forum. 2025 Dec 5;6(12):e255623. doi: 10.1001/jamahealthforum.2025.5623.
PubMed 41632198
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- E-mails to Nudge Safer and Better-Informed Prescribing of Risky Drugs
- ClinicalTrials.gov ID
- NCT06443385
- Acronym / sponsor ID
- AAAV1928
- Conditions
- Opioid Prescribing, Prescription Drug Misuse
- Keywords
- opioids, prescribing, overprescribing, prescription drug monitoring programs, controlled substances
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,872 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- University of Southern California, Bowdoin College, Abdul Latif Jameel Poverty Action Lab, Minnesota Management and Budget, Minnesota Board of Pharmacy
- Study start
- 17 Jul 2024 (actual)
- Primary completion
- 14 Sep 2024 (actual)
- Study completion
- 24 Sep 2025 (actual)
- First posted
- 5 Jun 2024 (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.
This study will test e-mails to encourage engagement with the Minnesota prescription monitoring program (PMP/PDMP) and will evaluate the effect of these e-mails on PMP/PDMP use and controlled substance prescribing.
Detailed description
Drug overdose deaths have skyrocketed in recent years, and many overdoses continue to involve prescribed medications like opioids and stimulants. At the same time, state prescription drug monitoring programs (PDMPs), which help clinicians prescribe these medications safely, remain underused. In Minnesota, 32% of opioid prescriptions are written by clinicians who do not use the PDMP. In many states, including Minnesota, policymakers have limited tools to raise PDMP use even though it is often required under state law. To address this policy dilemma, this study will test e-mails designed to facilitate PDMP use and evaluate their effects on PDMP use and controlled substance prescribing. This study will include a projected 7,126 physician and physician assistant prescribers of opioids and other controlled substances who lack active PDMP accounts, never query the PDMP, or query the PDMP infrequently relative to their prescribing volume. To generate evidence on clinician motivation for responding to encouragement, the study will randomly vary messaging to focus on legal requirements to use the PDMP vs. clinical benefits of the PDMP.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Clinicians will be assigned at random to one of three arms: PDMP legal mandate e-mails, PDMP clinical benefit emails, or a control group.
| Arm | Type | Receives |
|---|---|---|
| Legal Mandate Messaging | Experimental | Behavioral: PDMP Legal Mandate E-mail |
| Clinical Benefit Messaging | Experimental | Behavioral: PDMP Clinical Benefit E-mail |
| Control | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Minnesota physician or physician assistant
- Controlled substance prescriber not following state requirements to maintain an active PDMP account, or opioid prescriber not searching the PDMP or infrequently searching the PDMP
Key exclusion criteria (1 listed)
- No e-mail address available
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 |
|---|---|---|
| PDMP Legal Mandate E-mailE-mails highlighting the state's legal requirements to use the PDMP. There will be one initial email and one follow-up email one month later. | Behavioural | Legal Mandate Messaging |
| PDMP Clinical Benefit E-mailE-mails highlighting the clinical benefits of having access to the PDMP and checking the PDMP before prescribing opioids. There will be one initial email and one follow-up email one month later. | Behavioural | Clinical Benefit Messaging |
Primary outcome
Rate of PDMP Engagement
Time frame: 2 months
An indicator for increased PDMP engagement during the 2-month period after the first e-mails were sent. It will indicate whether the level of engagement rose from the baseline level that resulted in the clinician's enrollment into the study. For clinicians who lacked an account, the outcome will indicate whether they created one; for clinicians with an inactive account, the outcome will indicate whether they reactivated it. For those who never searched, it will indicate any search, and for those who rarely searched, it will indicate whether their search rate rose.
Volume of Potentially Guideline-discordant Opioid Prescribing
Time frame: 2 months
A composite of several measures of potentially guideline-discordant opioid prescribing. These will include: 1. Opioid co-prescriptions with other opioids 2. Opioid co-prescriptions with benzodiazepines 3. Opioid co-prescriptions with gabapentinoids 4. High daily opioid doses 5. Long-duration opioid prescriptions to opioid-naïve individuals
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Derived from this study: PubMed 41632198Sacarny A, Avilova T, Williamson I, Merrick W, Jacobson M. Prescription Drug Monitoring Program Reminder Emails, Program Use, and Prescribing: A Randomized Clinical Trial. JAMA Health Forum. 2025 Dec 5;6(12):e255623. doi: 10.1001/jamahealthforum.2025.5623.
- Individual participant dataSharing planned: No
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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.
Adam Sacarny, PhD principal investigator
Columbia University
Mireille Jacobson, PhD principal investigator
University of Southern California
Tatyana Avilova, PhD principal investigator
Bowdoin College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PDMP Legal Mandate E-mail and PDMP Clinical Benefit E-mail in people with Opioid Prescribing and Prescription Drug Misuse, run by Columbia University at 1 site in United States.
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 2 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: finished, as of the sponsor's last update on 11 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of PDMP Engagement (time frame: 2 months). The study lists 2 primary outcomes in all. 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 NCT06443385, 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 11 Feb 2026.