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Increasing Naloxone Access for Persons Who Use Opioids

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04303000
Enrollment
111
Registered
2020-03-10
Start date
2021-07-11
Completion date
2022-01-13
Last updated
2023-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Naloxone

Keywords

Opioid overdose, Naloxone distribution, Narcan, Online training

Brief 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. 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.

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.

Interventions

DRUGOpioid Overdose Education with Naloxone Distribution

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

DRUGOpioid Overdose Education

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.

Sponsors

University of Alabama at Birmingham
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Participant Knowledge of Opioid Overdose Response Procedures6 monthsMean 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.
The Number of Participants That Completed the Training in 6 Months6 monthsFeasibility 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.

Countries

United States

Participant flow

Recruitment details

Participants were recruited via online social media platforms (e.g., Craigslist) between July and October 2021.

Pre-assignment details

A total of 13 participants were not randomized to a group for the training portion of the study, as they did not complete the baseline assessment.

Participants by arm

ArmCount
Opioid Overdose Education and Naloxone Distribution
Participants engaged 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 were provided with a naloxone nasal spray kit (4mg). Opioid Overdose Education with Naloxone Distribution: Online audiovisual training focused on recognizing the signs of an opioid overdose and administering naloxone. Participants were provided with a naloxone kit.
55
Opioid Overdose Education
Participants engaged 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 received information about pharmacies in their area where they could purchase a naloxone kit. Opioid Overdose Education: Online audiovisual training focused on recognizing the signs of an opioid overdose and administering naloxone. Participants were provided with information on where they could obtain a naloxone kit.
56
Total111

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Opioid Use QuestionnaireWithdrawal by Subject1500

Baseline characteristics

CharacteristicOpioid Overdose Education and Naloxone DistributionTotalOpioid Overdose Education
Age, Continuous37.44 years
STANDARD_DEVIATION 9.08
37.93 years
STANDARD_DEVIATION 9.76
38.54 years
STANDARD_DEVIATION 10.54
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants4 Participants2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
53 Participants107 Participants54 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
5 Participants12 Participants7 Participants
Race (NIH/OMB)
More than one race
3 Participants7 Participants4 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
46 Participants91 Participants45 Participants
Region of Enrollment
United States
55 Participants111 Participants56 Participants
Sex: Female, Male
Female
35 Participants69 Participants34 Participants
Sex: Female, Male
Male
20 Participants42 Participants22 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 550 / 56
other
Total, other adverse events
0 / 550 / 56
serious
Total, serious adverse events
0 / 550 / 56

Outcome results

Primary

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.

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
Opioid Overdose Education and Naloxone DistributionChange in Participant Knowledge of Opioid Overdose Response Procedures1.48 score on a scaleStandard Deviation 1.83
Opioid Overdose EducationChange in Participant Knowledge of Opioid Overdose Response Procedures1.34 score on a scaleStandard Deviation 1.51
Primary

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.

Time frame: 6 months

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Opioid Overdose Education and Naloxone DistributionThe Number of Participants That Completed the Training in 6 MonthsEnrolled and Randomized55 Participants
Opioid Overdose Education and Naloxone DistributionThe Number of Participants That Completed the Training in 6 MonthsLost to Follow-up10 Participants
Opioid Overdose EducationThe Number of Participants That Completed the Training in 6 MonthsEnrolled and Randomized56 Participants
Opioid Overdose EducationThe Number of Participants That Completed the Training in 6 MonthsLost to Follow-up9 Participants

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026