Accidental Overdose of OpiateNCT07128485
Remote Intervention to Prevent Overdose
A study testing Overdose prevention resources and Overdose prevention education in people with Accidental Overdose of Opiate, run by University of Alabama at Birmingham at 2 sites in United States.
Trial summary
This Type 1 hybrid effectiveness-implementation randomized controlled trial, A Remote Intervention to Prevent Overdose among People who Use Stimulants and/or Opioids, aims to address the United States opioid crisis driven by fentanyl and other synthetic opioids by reducing overdose rates. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Accidental Overdose of Opiate
- What is being tested?
- Overdose prevention resources and Overdose prevention education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2027to Nov 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old
- English-speaking and reading
- Report using illicit opioids and/or stimulants (including counterfeit pills) within the past 3 months per the ASSIST
- Able and willing to provide informed consent
- Be able and willing to provide the names and contact information of three close contacts to reach if the participant cannot be reached
Who cannot join
- Living in a restricted environment (e.g., prison)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35233
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Emma S Kay, PhD, 205-996-5547, emmakay@uab.edu
Emma S Kay, PhD
About this study
Official title: A Remote Intervention to Prevent Overdose Among People Who Use Stimulants and/or Opioids
This Type 1 hybrid effectiveness-implementation randomized controlled trial, A Remote Intervention to Prevent Overdose among People who Use Stimulants and/or Opioids, aims to address the United States opioid crisis driven by fentanyl and other synthetic opioids by reducing overdose rates. It is supported by and included in the HEAL Initiative. This study would be the first national, fully remote trial to assess the impact of remote education on overdose outcomes, using a novel 2x2 design crossing remote education with remote access support. This research will inform scalability around remote education programs to address the nation's opioid overdose crisis.
Read the detailed description
This Type 1 hybrid effectiveness-implementation randomized controlled trial aims to address the United States overdose crisis driven by fentanyl and other synthetic opioids. Extant studies of overdose prevention programs are limited to single cities or regions and enroll from brick-and-mortar sites, with no national, fully remote RCTs to date, and it remains unknown whether education alone drives behavior change independent of access. This study will be the first national, fully remote trial to isolate the independent impact of remote education on overdose outcomes. This project adapts our opioid overdose education and naloxone distribution intervention using a human-centered design approach, leveraging community partnerships to co-create a fully remote intervention focused on overdose prevention strategies. Access to overdose prevention resources will be made available to participants independent of this award through referral to community partners. We will use a 2×2 design crossing remote education with remote access support, isolating the individual and combined effects of these two components. The R61 phase focuses on adapting and piloting the interventions with 100 participants, assessing feasibility, acceptability, and appropriateness. The R33 phase implements a fully powered trial to compare overdose outcomes (fatal and non-fatal) among 2,952 participants randomized to four arms: education plus access support, education only, access support only, and referral only (control). All groups will receive a resource list for overdose prevention tools. The secondary outcome is knowledge of how to use the resources correctly; exploratory outcomes include protective behavioral strategies to reduce overdose risk and utilization of substance use services and treatment. The study incorporates ecological momentary assessment to elucidate daily contextual factors influencing resource use, and a cost-effectiveness analysis to identify the most cost efficient approach. Findings will directly inform scalable, low-barrier models capable of reaching rural and underserved populations not currently engaged in substance use services.
- Conditions
- Accidental Overdose of Opiate
- Being tested
- Overdose prevention resources, Overdose prevention education
- Keywords
- overdose prevention, fentanyl, opioid use disorder, stimulant use disorder, accidental overdose
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Overdose prevention resourcesOther
Overdose prevention resources (e.g., naloxone) are resources used to prevent drug overdose.
Overdose prevention educationBehavioural
Developed in the R61 phase, the educational intervention will provide participants with knowledge about how prevent drug overdose.
| Study group | Role | What they receive |
|---|---|---|
| Education plus access support | Experimental | This arm receives both overdose prevention education and access to overdose prevention resources. Receives: Other: Overdose prevention resources; Behavioral: Overdose prevention education |
| Education only | Experimental | The Education only arm receives overdose prevention education. Receives: Behavioral: Overdose prevention education |
| Access support | Experimental | This arm receives access to overdose prevention resources. Receives: Other: Overdose prevention resources |
| Referral | No intervention | The referral only arm receives a resource list for obtaining naloxone and other overdose prevention resources on their own. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overdose
Includes both self-reported non-fatal overdose and fatal overdose
Measured: Baseline, 1 month, 3 months, 6 months
Secondary outcomes (1)
Overdose prevention knowledge
Self-reported knowledge of how and when to use overdose prevention tools correctly, based on the education intervention developed in R61 phase
Measured: Baseline, 1 month, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study startJan 2027 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accidental Overdose of OpiateStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Using a 2x2 design, there will be four study arms. All arms will receive a resource list for obtaining overdose prevention resources such as naloxone on their own, while while other arms will additionally receive overdose prevention education, access to overdose prevention resources, or both. These 4 groups include: education plus access support, education only, access support only, and referral only (control).
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Emma Kay, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07128485
- Sponsor's protocol ID
- IRB 300015053
- Other IDs
- 1R61DA065247-01
- Status last verified
- Oct 2026
- First submitted
- 13 Aug 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Remote Intervention to Prevent Overdose Among People Who Use Stimulants and/or Opioids
- ClinicalTrials.gov ID
- NCT07128485
- Acronym / sponsor ID
- IRB 300015053
- Conditions
- Accidental Overdose of Opiate
- Keywords
- overdose prevention, fentanyl, opioid use disorder, stimulant use disorder, accidental overdose
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jan 2027 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 19 Aug 2025 (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 Type 1 hybrid effectiveness-implementation randomized controlled trial, A Remote Intervention to Prevent Overdose among People who Use Stimulants and/or Opioids, aims to address the United States opioid crisis driven by fentanyl and other synthetic opioids by reducing overdose rates. It is supported by and included in the HEAL Initiative. This study would be the first national, fully remote trial to assess the impact of remote education on overdose outcomes, using a novel 2x2 design crossing remote education with remote access support. This research will inform scalability around remote education programs to address the nation's opioid overdose crisis.
Detailed description
This Type 1 hybrid effectiveness-implementation randomized controlled trial aims to address the United States overdose crisis driven by fentanyl and other synthetic opioids. Extant studies of overdose prevention programs are limited to single cities or regions and enroll from brick-and-mortar sites, with no national, fully remote RCTs to date, and it remains unknown whether education alone drives behavior change independent of access. This study will be the first national, fully remote trial to isolate the independent impact of remote education on overdose outcomes. This project adapts our opioid overdose education and naloxone distribution intervention using a human-centered design approach, leveraging community partnerships to co-create a fully remote intervention focused on overdose prevention strategies. Access to overdose prevention resources will be made available to participants independent of this award through referral to community partners. We will use a 2×2 design crossing remote education with remote access support, isolating the individual and combined effects of these two components. The R61 phase focuses on adapting and piloting the interventions with 100 participants, assessing feasibility, acceptability, and appropriateness. The R33 phase implements a fully powered trial to compare overdose outcomes (fatal and non-fatal) among 2,952 participants randomized to four arms: education plus access support, education only, access support only, and referral only (control). All groups will receive a resource list for overdose prevention tools. The secondary outcome is knowledge of how to use the resources correctly; exploratory outcomes include protective behavioral strategies to reduce overdose risk and utilization of substance use services and treatment. The study incorporates ecological momentary assessment to elucidate daily contextual factors influencing resource use, and a cost-effectiveness analysis to identify the most cost efficient approach. Findings will directly inform scalable, low-barrier models capable of reaching rural and underserved populations not currently engaged in substance use services.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Using a 2x2 design, there will be four study arms. All arms will receive a resource list for obtaining overdose prevention resources such as naloxone on their own, while while other arms will additionally receive overdose prevention education, access to overdose prevention resources, or both. These 4 groups include: education plus access support, education only, access support only, and referral only (control).
| Arm | Type | Receives |
|---|---|---|
| Education plus access support | Experimental | Other: Overdose prevention resources, Behavioral: Overdose prevention educationThis arm receives both overdose prevention education and access to overdose prevention resources. |
| Education only | Experimental | Behavioral: Overdose prevention educationThe Education only arm receives overdose prevention education. |
| Access support | Experimental | Other: Overdose prevention resourcesThis arm receives access to overdose prevention resources. |
| Referral | No intervention | –The referral only arm receives a resource list for obtaining naloxone and other overdose prevention resources on their own. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years old
- English-speaking and reading
- Report using illicit opioids and/or stimulants (including counterfeit pills) within the past 3 months per the ASSIST
- Able and willing to provide informed consent
- Be able and willing to provide the names and contact information of three close contacts to reach if the participant cannot be reached
Key exclusion criteria (1 listed)
- Living in a restricted environment (e.g., prison)
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 |
|---|---|---|
| Overdose prevention resourcesOverdose prevention resources (e.g., naloxone) are resources used to prevent drug overdose. | Other | Access support, Education plus access support |
| Overdose prevention educationDeveloped in the R61 phase, the educational intervention will provide participants with knowledge about how prevent drug overdose. | Behavioural | Education only, Education plus access support |
Primary outcome
Overdose
Time frame: Baseline, 1 month, 3 months, 6 months
Includes both self-reported non-fatal overdose and fatal overdose
1 secondary outcome
Overdose prevention knowledge
Time frame: Baseline, 1 month, 3 months, 6 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 16 Oct 2026.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Overdose prevention resources and Overdose prevention education in people with Accidental Overdose of Opiate, run by University of Alabama at Birmingham 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: opening soon, as of the sponsor's last update on 16 Oct 2026. 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?
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?
Contact Emma S Kay, PhD, MSW (205-996-5547, emmakay@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overdose (time frame: Baseline, 1 month, 3 months, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2026.