Opioid OverdoseNCT03924505

Preventing Opioid Overdose Mortality in the United States

A study testing Organize and Mobilize for Implementation Effectiveness and Dissemination in people with Opioid Overdose, run by RTI International at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Opioid Overdose
What is being tested?: Organize and Mobilize for Implementation Effectiveness and Dissemination
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 105 participants
Where: 1 siteUnited States
Study dates: 3 Sep 2019to 14 Mar 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

To be eligible, an organization must have: 1) met the definition of an SSP - an organization whose primary function is to distribute drug use supplies to participants to reduce harms associated with drug use, 2) implemented OEND for a minimum of 6 months, and 3) completed the national survey of syringe services programs fielded February-July 2019. We excluded organizations such as fire departments or emergency departments of hospitals that offered supply distribution since it would be an ancillary function of these organizations and OEND programs that were not part of a syringe services program.

Trial locations and contacts

1 site in 1 country.

United States1 site

RTI International
Berkeley, California, 94704

Other trials in United States

About this study

This study aims to conduct a randomized controlled trial of 105 syringe services programs (SSPs) throughout the United States to understand the effectiveness of a multifaceted, facilitation-based strategy at advancing naloxone implementation effectiveness within SSPs. Together, these efforts can improve access to naloxone for people at high risk of overdose, thereby improving our nation's response to the opioid overdose epidemic.

Read the detailed description

We conducted a randomized controlled trial of SSPs throughout the United States (US) and US Territories. Prior to the trial, 342 SSPs were known to be operating throughout the US and US Territories. Our team launched a national survey of syringe services programs (NSSSP) in February 2019 of all known SSPs operating throughout the United States and its Territories, receiving a response from 263 (77%) SSPs. Among the responding SSPs, 94% were implementing overdose education and naloxone distribution (OEND), and a total of 105 of SSPs implementing OEND were recruited into the trial. SSPs were randomized in a 1-to-1 fashion to either receive the OEND best practice recommendations (comparison SSPs) or the OEND best practice recommendations along with facilitation-based implementation strategies as detailed below (intervention SSPs).

We tested the effectiveness of a multifaceted, facilitation-based strategy at advancing OEND implementation effectiveness within SSPs. Implementation effectiveness is 'an organization-level construct that refers to the aggregated consistency, quality, and appropriateness of innovation use (OEND) within an organization (SSP).'

Conditions: Opioid Overdose
Being tested: Organize and Mobilize for Implementation Effectiveness, Dissemination
Keywords: Implementation Science, Harm Reduction
Medical subject headings: Opiate Overdose, Harm Reduction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Organize and Mobilize for Implementation EffectivenessOther
Our trial is trying to understand how a multi-faceted, facilitation-based implementation strategy advances effective implementation of naloxone within syringe services programs
DisseminationOther
Our comparison group receives dissemination of best practice recommendations for naloxone implementation.

Study groups in NCT03924505
Study group	Role	What they receive
Organize and Mobilize for Implementation Effectiveness	Experimental	Our approach was based on the Implementation Sustainment Facilitation (ISF), which is grounded in the theory of implementation effectiveness, and added discrete strategies from the Addiction Technology Transfer Center (ATTC), which were considered necessary elements from the original ISF trial. In addition to receiving the OEND best practice recommendations, our multi-component approach used external facilitation as the overarching strategy, by which seven other strategies were leveraged to support SSP staff and leadership. In addition to external facilitation, the multi-faceted approach included: organize implementation team meetings, identify and prepare champions, develop and organize quality monitoring system, assess for readiness and identify barriers, distribute educational materials and resources, conduct educational meetings, and provide ongoing consultation. Receives: Other: Organize and Mobilize for Implementation Effectiveness
Dissemination of Best Practice Recommendations	Active comparator	This arm will receive the best practice recommendations for implementing overdose education and naloxone distribution within syringe services programs. Receives: Other: Dissemination

What is being measured

The primary outcome is the main question the study is designed to answer.

Naloxone Coverage (Consistency)
Mean number of syringe services program participants receiving naloxone per total number of syringe services program participants
Measured: 3 months
Naloxone Doses Distributed (Consistency)
The mean number of naloxone doses distributed per total number of SSP participants
Measured: 3 months
Best Practice Adoption (Implementation Quality)
The mean number of best practices adopted by the SSP
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Sep 201914 Mar 2022

First posted23 Apr 2019
Study start3 Sep 2019
Primary completion14 Mar 2022
Study completion14 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Opioid OverdoseStudies 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 105 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03924505
Sponsor's protocol ID: INOD
Other IDs: R01DA046867
Status last verified: Dec 2024
First submitted: 19 Apr 2019
Last updated: 12 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Lambdin BH, Bluthenthal RN, Garner BR, Wenger LD, Browne EN, Morris T, Ongais L, Megerian CE, Kral AH. Organize and mobilize for implementation effectiveness to improve overdose education and naloxone distribution from syringe services programs: a randomized controlled trial. Implement Sci. 2024 Feb 28;19(1):22. doi: 10.1186/s13012-024-01354-y.
PubMed 38419058

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Disease Intervention Specialist (DIS) for SUD
Substance Use Disorder (SUD), Opioid Use Disorder
Not yet recruiting
Prevention and Rapid Outreach for Treatment, Engagement, and Care Transition From the Emergency Department
Opioid Overdose Prevention, HIV Prevention and Care
Not yet recruiting
Remote Intervention to Prevent Overdose
Accidental Overdose of Opiate
Enrolling by invitation
PATH to Reducing Burnout Among Peers Who Deliver Overdose Prevention Services (R33 Phase Clinical Trial)
Burnout, Secondary Trauma
Active, not recruiting
Improving Access to Naloxone to Prevent Opioid Overdose Deaths (SAIA-Naloxone)
Overdose, Implementation as Usual

All Opioid Overdose trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Preventing Opioid Overdose Mortality in the United States
ClinicalTrials.gov ID: NCT03924505
Acronym / sponsor ID: INOD
Conditions: Opioid Overdose
Keywords: Implementation Science, Harm Reduction
Study type: Interventional
Recruitment status: Completed
Enrolment: 105 participants (actual)
Lead sponsor: RTI InternationalUniversity, hospital or other
Collaborators: National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
Study start: 3 Sep 2019 (actual)
Primary completion: 14 Mar 2022 (actual)
Study completion: 14 Mar 2022 (actual)
First posted: 23 Apr 2019 (actual)
Results: Posted 12 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Organize and Mobilize for Implementation Effectiveness	Experimental	Other: Organize and Mobilize for Implementation EffectivenessOur approach was based on the Implementation Sustainment Facilitation (ISF), which is grounded in the theory of implementation effectiveness, and added discrete strategies from the Addiction Technology Transfer Center (ATTC), which were considered necessary elements from the original ISF trial. In addition to receiving the OEND best practice recommendations, our multi-component approach used external facilitation as the overarching strategy, by which seven other strategies were leveraged to support SSP staff and leadership. In addition to external facilitation, the multi-faceted approach included: organize implementation team meetings, identify and prepare champions, develop and organize quality monitoring system, assess for readiness and identify barriers, distribute educational materials and resources, conduct educational meetings, and provide ongoing consultation.
Dissemination of Best Practice Recommendations	Active comparator	Other: DisseminationThis arm will receive the best practice recommendations for implementing overdose education and naloxone distribution within syringe services programs.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

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
Organize and Mobilize for Implementation EffectivenessOur trial is trying to understand how a multi-faceted, facilitation-based implementation strategy advances effective implementation of naloxone within syringe services programs	Other	Organize and Mobilize for Implementation Effectiveness
DisseminationOur comparison group receives dissemination of best practice recommendations for naloxone implementation.	Other	Dissemination of Best Practice Recommendations

Primary outcome

Naloxone Coverage (Consistency)
Time frame: 3 months
Mean number of syringe services program participants receiving naloxone per total number of syringe services program participants
Naloxone Doses Distributed (Consistency)
Time frame: 3 months
The mean number of naloxone doses distributed per total number of SSP participants
Best Practice Adoption (Implementation Quality)
Time frame: 12 months
The mean number of best practices adopted by the SSP

Results and safety

Results posted to the registry on 12 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Organize and Mobilize for Implementation Effectiveness	53	51
Implementation Manual - Only	52	51

Primary outcome: Naloxone Coverage (Consistency)

Time frame: 3 months. Mean (Standard Deviation). Unit: proportion of participants

Measure	Organize and Mobilize for Implementation Effectiveness n = 45	Dissemination of Best Practice Recommendations n = 49
Value	0.9 (1.4)	0.4 (0.3)

Organize and Mobilize for Implementation Effectiveness vs Dissemination of Best Practice Recommendations: Incidence Rate Ratio: 2.15 (95% CI 1.42 to 2.35), p <0.01, Negative Binomial Regression

Primary outcome: Naloxone Doses Distributed (Consistency)

Time frame: 3 months. Mean (Standard Deviation). Unit: naloxone doses

Measure	Organize and Mobilize for Implementation Effectiveness n = 46	Dissemination of Best Practice Recommendations n = 50
Value	2.5 (2.6)	1.3 (1.2)

Organize and Mobilize for Implementation Effectiveness vs Dissemination of Best Practice Recommendations: Incidence Rate Ratio: 1.97 (95% CI 1.18 to 3.30), p = 0.01, Negative Binomial Regression

Primary outcome: Best Practice Adoption (Implementation Quality)

Time frame: 12 months. Mean (Full Range). Unit: number of best practices

Measure	Organize and Mobilize for Implementation Effectiveness n = 51	Implementation Manual - Only n = 51
Value	13.1 (8 to 18)	12.9 (8 to 17)

Organize and Mobilize for Implementation Effectiveness vs Implementation Manual - Only: Mean Difference (Final Values): 0.2 (95% CI -0.7 to 1.0), p = 0.68, t-test, 2 sided

Adverse events

Time frame: 12 months of the intervention period. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Organize and Mobilize for Implementation Effectiveness	0 of 51 (0%)	0 of 51 (0%)	0 of 51
Dissemination of Best Practice Recommendations	0 of 51 (0%)	0 of 51 (0%)	0 of 51

Limitations and caveats (from the sponsor): A noteworthy limitation with our trial is the reliance on self-report for the number of naloxone doses distributed, number of people receiving naloxone and best practice implementation. However, SSPs routinely report naloxone distribution metrics for funders. Generalizability of our study findings requires careful consideration. While we randomly selected SSPs to participate, it is possible that those that enrolled had different levels of resources than those that did not participate.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38419058Lambdin BH, Bluthenthal RN, Garner BR, Wenger LD, Browne EN, Morris T, Ongais L, Megerian CE, Kral AH. Organize and mobilize for implementation effectiveness to improve overdose education and naloxone distribution from syringe services programs: a randomized controlled trial. Implement Sci. 2024 Feb 28;19(1):22. doi: 10.1186/s13012-024-01354-y.
Individual participant dataSharing planned: No

Related trials for Opioid Overdose

Not yet recruitingObservational study
Disease Intervention Specialist (DIS) for SUD
Substance Use Disorder (SUD), Opioid Use Disorder
Not yet recruiting
Prevention and Rapid Outreach for Treatment, Engagement, and Care Transition From the Emergency Department
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Not yet recruiting
Remote Intervention to Prevent Overdose
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Enrolling by invitation
PATH to Reducing Burnout Among Peers Who Deliver Overdose Prevention Services (R33 Phase Clinical Trial)
Burnout, Secondary Trauma
Active, not recruiting
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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.

Barrot Lambdin, PhD, MPH principal investigator

RTI International

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Organize and Mobilize for Implementation Effectiveness and Dissemination in people with Opioid Overdose, run by RTI International 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?

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 12 Dec 2024. 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?

Yes. Results are posted in the registry (first posted 12 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Naloxone Coverage (Consistency) (time frame: 3 months). The study lists 3 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 NCT03924505, 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 12 Dec 2024.