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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Opioid Overdose Education and Naloxone Distribution | Experimental | Participants 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). |
|
| Opioid Overdose Education | Active Comparator | Participants 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Opioid Overdose Education with Naloxone Distribution | Drug | Online audiovisual training focused on recognizing the signs of an opioid overdose and administering naloxone. Participants are provided with a naloxone kit. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| 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. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle Sisson, MA | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Craigslist | Anniston | Alabama | 36201 | United States | ||
| Craigslist |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39514898 | Derived | 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. | |
| 37336007 |
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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 were recruited via online social media platforms (e.g., Craigslist) between July and October 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Screened Participants | Started and completed screening |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Opioid Use Questionnaire |
|
| ||||||||||||||||||
| Training Portion |
|
Baseline characteristics described here are for the 111 participants enrolled in the training portion of the study who were randomized to either the "Opioid Overdose Education and Naloxone Distribution" or "Opioid Overdose Education" groups.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 6 months |
|
6 months
Adverse events were not collected during the pre-randomization period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melinda Clarke | University of Alabama at Birmingham | 205-975-7809 | melindaclarke@uabmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 11, 2022 | Jul 2, 2023 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D000083682 | Opiate Overdose |
| ID | Term |
|---|---|
| D062787 | Drug Overdose |
| D063487 | Prescription Drug Misuse |
| D000076064 | Drug Misuse |
| D019966 | Substance-Related Disorders |
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| ID | Term |
|---|---|
| D009270 | Naloxone |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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|
| Opioid Overdose Education | Drug | 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. |
|
|
| Gadsden |
| Alabama |
| 35901 |
| United States |
| Craigslist | Mobile | Alabama | 36695 | United States |
| Craigslist | Montgomery | Alabama | 36117 | United States |
| 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. |
| 37091508 | Derived | 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. |
| Month 2 Follow-Up |
|
| Month 3 Follow-Up |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
| 0 |
| 55 |
| 0 |
| 55 |
| 0 |
| 55 |
| EG001 | 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. | 0 | 56 | 0 | 56 | 0 | 56 |
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| D064419 |
| Chemically-Induced Disorders |
| D009293 | Opioid-Related Disorders |
| D000079524 | Narcotic-Related Disorders |
| D001523 | Mental Disorders |
| D006572 |
| Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |