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AzTrials

NaloxonePhase 4NCT04303000

Increasing Naloxone Access for Persons Who Use Opioids

A Phase 4 study testing Opioid Overdose Education with Naloxone Distribution and Opioid Overdose Education in people with Naloxone, run by University of Alabama at Birmingham at 4 sites 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

Deaths relating to opioid overdose have rapidly increased over the past two decades. Due to the serious public health concern of the opioid epidemic, federal agencies recommend employing various harm reduction interventions. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Naloxone
What is being tested?
Opioid Overdose Education with Naloxone Distribution and Opioid Overdose Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
111 participants
Where
4 sitesUnited States
Study dates
11 Jul 2021to 13 Jan 2022
Phase
Phase 4
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years of age or older
  • Current or past six months illicit use of opioids
  • Electronic device access for online survey completion
  • Willing to provide email address to receive survey link and compensation
  • Able to read and speak English
  • Willing to provide their contact information and that of two friends/family members
  • Permanent address for mailing of naloxone kit
  • Does not currently have a naloxone kit in possession

Who cannot join

  • Contraindication for naloxone (known severe allergic reaction)
  • Cognitive impairment or unstable psychiatric condition that interferes with the informed consent process

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Craigslist

    Anniston, Alabama, 36201

  • Craigslist

    Gadsden, Alabama, 35901

  • Craigslist

    Mobile, Alabama, 36695

  • Craigslist

    Montgomery, Alabama, 36117

Other trials in United States

About this study

Official title: Increasing Naloxone Access for Persons Who Use Opioids: An Online Recruitment and Training Approach to Opioid Overdose Education and Naloxone Distribution

Deaths relating to opioid overdose have rapidly increased over the past two decades. Due to the serious public health concern of the opioid epidemic, federal agencies recommend employing various harm reduction interventions. The implementation of Opioid Overdose Education and Naloxone Distribution (OEND) programs is effective in reducing opioid overdose mortality, yet these programs do not reach many high-risk individuals. Traditionally, OEND program venues are found in large, urban medical centers, drug treatment facilities, and needle exchange programs. Identifying unreached, high-risk individuals and providing training and naloxone kits through online recruitment could significantly expand access to this life-saving intervention. The primary goal of the current proposed project is to examine the acceptability and feasibility of online recruitment, online opioid overdose and naloxone administration education, and postal distribution of naloxone kits.

Read the detailed description

Drug overdose is the leading cause of accidental death in the United States, with over 65% of drug related fatalities resulting from the use of opioids. The continually increasing rates of opioid overdose deaths in the last two decades have led to the declaration of an opioid epidemic. Over a brief 15-year period, from 1999-2014, drug overdose related deaths tripled and rates have continued to sharply escalate since then. Federal agencies have responded to this crisis with various recommendations including enhancing harm reduction approaches such as naloxone distribution. Naloxone is an opioid antagonist that can be used to reverse opioid overdose. Though it is typically administered in Emergency Departments, laypersons have recently been successfully trained through Opioid Overdose Education and Naloxone Distribution (OEND) programs to recognize signs of opioid overdose and perform timely administration of naloxone in homes and community settings while awaiting medical services. Several studies have demonstrated that OEND programs effectively reduce opioid overdose mortality and are safe and cost-effective. However, OEND programs are typically implemented in urban areas as part of large medical center research programs, needle exchanges, or drug treatment programs. Individuals living in areas without these programs or services lack access to critical and life-saving OEND. The current proposal will examine the acceptability and feasibility of online recruitment, online opioid overdose education, and postal distribution of naloxone kits (N=80). Opioid users at risk for overdose will be recruited online through Craigslist. If eligible, participants will complete an opioid use questionnaire and will indicate if they are interested in receiving opioid overdose and naloxone administration training. If interested, they will complete pre- and post-intervention knowledge questionnaires, engage in audiovisual training, and half will be randomized to receive a naloxone kit in the mail while the other half will be given information on where they can receive a naloxone kit. All participants will complete remote follow-up assessments at 1, 2, and 3 months post study to evaluate naloxone kit use and outcomes. This study will evaluate a novel approach to providing OEND to individuals with otherwise limited access to this type of intervention. Successful implementation of remote OEND through this project would support future employment of similar remote programs to expand this critical harm reduction strategy to high-risk individuals in areas lacking traditional OEND programs.

Conditions
Naloxone
Being tested
Opioid Overdose Education with Naloxone Distribution, Opioid Overdose Education
Keywords
Opioid overdose, Naloxone distribution, Narcan, Online training
Medical subject headings
Opiate Overdose

What participants receive

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

  • Opioid Overdose Education with Naloxone DistributionDrug

    Also called Narcan

    Online audiovisual training focused on recognizing the signs of an opioid overdose and administering naloxone. Participants are provided with a naloxone kit.

  • Opioid Overdose EducationDrug

    Also called Narcan

    Online audiovisual training focused on recognizing the signs of an opioid overdose and administering naloxone. Participants are provided with information on where they can obtain a naloxone kit.

Study groups in NCT04303000
Study groupRoleWhat they receive
Opioid Overdose Education and Naloxone DistributionExperimentalParticipants will engage in online audiovisual training focused on recognizing the signs of an opioid overdose and the procedural steps for how to administer naloxone. Participants randomized to this arm will be provided with a naloxone nasal spray kit (4mg).
Receives: Drug: Opioid Overdose Education with Naloxone Distribution
Opioid Overdose EducationActive comparatorParticipants will engage in online audiovisual training focused on recognizing the signs of an opioid overdose and the procedural steps for how to administer naloxone. Participants randomized to this arm will receive information about pharmacies in their area where they can purchase a naloxone kit.
Receives: Drug: Opioid Overdose Education

What is being measured

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

  1. The Number of Participants That Completed the Training in 6 Months

    Feasibility of online opioid overdose education and remote naloxone distribution as indicated by recruitment of at least 80 total participants in 6 months. There was not a calculated measure, and this aspect of feasibility was based on ability to recruit a set number of participants in a predetermined amount of time.

    Measured: 6 months

  2. Change in Participant Knowledge of Opioid Overdose Response Procedures

    Mean change in participant knowledge as indicated by difference in scores on pre- and post-training knowledge questionnaires on a scale of 1 to 9 where 9 indicates greater knowledge.

    Measured: 6 months

Timeline

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

  1. First posted10 Mar 2020
  2. Study start11 Jul 2021
  3. Primary completion13 Jan 2022
  4. Study completion13 Jan 2022

Resources

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 4
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
111 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04303000
Sponsor's protocol ID
IRB-300004762
Status last verified
Oct 2023
First submitted
3 Mar 2020
Last updated
30 Oct 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sisson ML, Azuero A, Hawes E, Chichester KR, Carpenter MJ, Businelle MS, Shelton RC, Cropsey KL. Characterizing Individuals Who Elect and Decline Opioid Overdose Education and Naloxone Distribution to Tailor Programs and Expand Impact. J Addict Med. 2025 May-Jun 01;19(3):268-273. doi: 10.1097/ADM.0000000000001407. Epub 2024 Nov 8.

    PubMed 39514898

  • Sisson ML, Azuero A, Chichester KR, Carpenter MJ, Businelle MS, Shelton RC, Cropsey KL. Preliminary effectiveness of online opioid overdose and naloxone administration training and impact of naloxone possession on opioid use. Drug Alcohol Depend. 2023 Aug 1;249:110815. doi: 10.1016/j.drugalcdep.2023.110815. Epub 2023 Jun 7.

    PubMed 37336007

  • Sisson ML, Azuero A, Chichester KR, Carpenter MJ, Businelle MS, Shelton RC, Cropsey KL. Feasibility and acceptability of online opioid overdose education and naloxone distribution: Study protocol and preliminary results from a randomized pilot clinical trial. Contemp Clin Trials Commun. 2023 Apr 5;33:101131. doi: 10.1016/j.conctc.2023.101131. eCollection 2023 Jun.

    PubMed 37091508

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Opioid Overdose Education with Naloxone Distribution and Opioid Overdose Education in people with Naloxone, run by University of Alabama at Birmingham at 4 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 8 inclusion and 2 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 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Oct 2023). 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?

The Number of Participants That Completed the Training in 6 Months (time frame: 6 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 NCT04303000, which also lists 3 linked publications.

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 30 Oct 2023.

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