Opioid-Related DisordersPTSLNCT03175640
Prescribe to Save Lives
A study testing Implementation intervention in people with Opioid-Related Disorders and Drug Overdose, run by Baystate Medical Center at 2 sites in United States.
Trial summary
The U.S. is in the midst of an epidemic of opioid overdose deaths. The common use of opioids among persons living with HIV, along with their common use of benzodiazepines, has resulted in high rates of opioid overdose among this population. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Opioid-Related Disorders, Drug Overdose
- What is being tested?
- Implementation intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 294 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Jul 2017to 31 Dec 2019
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinicians and staff of HIV practice sites that:
- Receive Ryan White Funding;
- Treat adults with HIV;
- Have 3 or more prescribing clinicians;
- Have an electronic medical record (EMR) with an electronic medication list.
Who cannot join
- Sites located in states with fewer than 500 Persons Living With HIV (PLWH) will be excluded
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Miriam Hospital
Providence, Rhode Island, 02906
University of Massachusetts Medical School - Baystate
Springfield, Massachusetts, 01199
About this study
Official title: Implementation to Motivate Physician Response to Opioid Dependence in HIV Settings
The U.S. is in the midst of an epidemic of opioid overdose deaths. The common use of opioids among persons living with HIV, along with their common use of benzodiazepines, has resulted in high rates of opioid overdose among this population. This study will test the implementation of evidence-based training, mentoring, technical support, and academic detailing to encourage HIV physicians to adopt evidence-based interventions to reduce overdose risk and treat opioid addiction.
- Conditions
- Opioid-Related Disorders, Drug Overdose
- Being tested
- Implementation intervention
- Medical subject headings
- Opioid-Related Disorders, Drug Overdose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation interventionBehavioural
The implementation intervention includes peer-to-peer training, post-training outreach, proactive expert support, and assistance with addressing environmental barriers.
| Study group | Role | What they receive |
|---|---|---|
| Implementation intervention | Experimental | Not described Receives: Behavioral: Implementation intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in naloxone prescribing behavior
Number of clinicians that prescribe naloxone. This information will be collected from electronic medical record (EMR) data.
Measured: baseline to 6 months
Secondary outcomes (6)
Change in perception about pharmacotherapy for opioid use disorder; 6-month
Opinions About Medication Assisted Treatment (OAMAT) survey
Measured: baseline to 6 months
Change in perception about pharmacotherapy for opioid use disorder; 12-month
Opinions About Medication Assisted Treatment (OAMAT) survey
Measured: baseline to 12 months
Change in prescribing motivation; 6 months
Change in Motivation Scale
Measured: baseline to 6 months
Change in prescribing motivation; 12 months
Change in Motivation Scale
Measured: baseline to 12 months
Change in prescriber training
Number of prescribers that have completed buprenorphine training.
Measured: baseline to 12 months
Change in buprenorphine prescribing behavior
Prevalence of buprenorphine prescription. This information will be collected from EMR data.
Measured: baseline to 12 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 2017
- Study start12 Jul 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baystate Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), The Miriam Hospital, Boston Medical Center, Rhode Island Hospital
- Responsible party
- Principal investigator, Peter Friedmann, Baystate Medical Center
- Investigators
- Peter D Friedmann, MD, MPH, Principal investigator, University of Massachusetts Medical School - BaystateJosiah D Rich, MD, MPH, Principal investigator, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03175640
- Sponsor's protocol ID
- BH-15-259
- Other IDs
- R01DA038082
- Acronym
- PTSL
- Status last verified
- Dec 2020
- First submitted
- 18 May 2017
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will make study data available to the community of scientists and the public in keeping with NIDA policies. After all data have been collected and the results of the major papers are in press, de-identified data will be made available to other qualified researchers on request. The request will be evaluated by Dr. Friedmann to ensure that it meets reasonable standards of scientific integrity. Ultimately, it is anticipated that de-identified data and codebooks will be warehoused and available through the ICPSR and SAMHDA websites. This data sharing plan will comply with the requirements of the privacy rule and federal regulations under HIPAA and 42 CFR Part 2 that govern the protection of individually identifiable information.
Publications
Jawa R, Walley AY, Wilson DJ, Green TC, McKenzie M, Hoskinson R Jr, Bratberg J, Ramsey S, Rich JD, Friedmann PD. Prescribe to Save Lives: Improving Buprenorphine Prescribing Among HIV Clinicians. J Acquir Immune Defic Syndr. 2022 Aug 15;90(5):546-552. doi: 10.1097/QAI.0000000000003001.
PubMed 35587832
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation to Motivate Physician Response to Opioid Dependence in HIV Settings
- ClinicalTrials.gov ID
- NCT03175640
- Acronym / sponsor ID
- PTSL / BH-15-259
- Conditions
- Opioid-Related Disorders, Drug Overdose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- Baystate Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), The Miriam Hospital, Boston Medical Center, Rhode Island Hospital
- Study start
- 12 Jul 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 5 Jun 2017 (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.
The U.S. is in the midst of an epidemic of opioid overdose deaths. The common use of opioids among persons living with HIV, along with their common use of benzodiazepines, has resulted in high rates of opioid overdose among this population. This study will test the implementation of evidence-based training, mentoring, technical support, and academic detailing to encourage HIV physicians to adopt evidence-based interventions to reduce overdose risk and treat opioid addiction.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implementation intervention | Experimental | Behavioral: Implementation intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Receive Ryan White Funding;
- Treat adults with HIV;
- Have 3 or more prescribing clinicians;
- Have an electronic medical record (EMR) with an electronic medication list.
Key exclusion criteria (1 listed)
- Sites located in states with fewer than 500 Persons Living With HIV (PLWH) will be excluded
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 |
|---|---|---|
| Implementation interventionThe implementation intervention includes peer-to-peer training, post-training outreach, proactive expert support, and assistance with addressing environmental barriers. | Behavioural | Implementation intervention |
Primary outcome
Change in naloxone prescribing behavior
Time frame: baseline to 6 months
Number of clinicians that prescribe naloxone. This information will be collected from electronic medical record (EMR) data.
6 secondary outcomes
Change in perception about pharmacotherapy for opioid use disorder; 6-month
Time frame: baseline to 6 months
Change in perception about pharmacotherapy for opioid use disorder; 12-month
Time frame: baseline to 12 months
Change in prescribing motivation; 6 months
Time frame: baseline to 6 months
Change in prescribing motivation; 12 months
Time frame: baseline to 12 months
Change in prescriber training
Time frame: baseline to 12 months
Change in buprenorphine prescribing behavior
Time frame: baseline to 12 months
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 21 Dec 2020.
- Derived from this study: PubMed 35587832Jawa R, Walley AY, Wilson DJ, Green TC, McKenzie M, Hoskinson R Jr, Bratberg J, Ramsey S, Rich JD, Friedmann PD. Prescribe to Save Lives: Improving Buprenorphine Prescribing Among HIV Clinicians. J Acquir Immune Defic Syndr. 2022 Aug 15;90(5):546-552. doi: 10.1097/QAI.0000000000003001.
- Individual participant dataSharing planned: Yes. The investigators will make study data available to the community of scientists and the public in keeping with NIDA policies. After all data have been collected and the results of the major papers are in press, de-identified data will be made available to other qualified researchers on request. The request will be evaluated by Dr. Friedmann to ensure that it meets reasonable standards of scientific integrity. Ultimately, it is anticipated that de-identified data and codebooks will be warehoused and available through the ICPSR and SAMHDA websites. This data sharing plan will comply with the requirements of the privacy rule and federal regulations under HIPAA and 42 CFR Part 2 that govern the protection of individually identifiable information.
Related trials for Opioid-Related Disorders
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RecruitingPhase 2
A Study of Cebranopadol for Opioid Withdrawal Symptoms in Adults With Chronic Pain
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MATAspire: Mental Health Awareness Tailored App for Substance Prevention and Integrated Resilience Education
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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.
Peter D Friedmann, MD, MPH principal investigator
University of Massachusetts Medical School - Baystate
Josiah D Rich, MD, MPH principal investigator
The Miriam Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation intervention in people with Opioid-Related Disorders and Drug Overdose, run by Baystate Medical Center at 2 sites 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 5 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 21 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Change in naloxone prescribing behavior (time frame: baseline to 6 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 NCT03175640, 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 21 Dec 2020; AzTrials last refreshed its copy on 26 Oct 2026.