An interventional study of Peer Education and Narcan Nasal Product in Overdose, sponsored by Johns Hopkins Bloomberg School of Public Health. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-24.
Sponsored by Johns Hopkins Bloomberg School of Public Health · Not applicable, Interventional, and Prevention
Among 72 studies in Drug Overdose with a site in United States — 17 open to participants now, 28 under way, none of them phase 3. Drug Overdose · United States.
Among the 72 studies in Drug Overdose with a site in United States, this one is the 9th largest by enrollment of the 58 interventional ones that give a count, is one of 10 that started in 2019, is one of 51 with no phase, and was the 29th registered.
104 studies on the registry are indexed under Drug Overdose; 22 are open to participants now.
Browse Drug Overdose studies →17 of the 72 studies in Drug Overdose with a site in United States are open now. Recruiting first, the newest first:
Boston Medical Center · Sites in United States
Ages 13+
San Francisco Department of Public Health · Sites in United States
Ages 18+ · Healthy volunteers
University of Wisconsin, Madison · Sites in United States
Ages 18+
Michele Staton · Sites in United States
Ages 18+ · Women only · Healthy volunteers
NYU Langone Health · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 13 Drug Overdose studies recruiting now, 12 (92%) set no upper age limit and 1 (8%) stops at 75 or younger; 3 take children under 18; 5 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
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72 studies; the count open now beside each. This study's row is marked.
First in 2010; this study’s year is marked. 10 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 614 is above the median of 124 across 76 interventional studies indexed under Drug Overdose.
Median enrollment 182 across the 58 interventional studies, 217 across the 14 observational. Of the 40 that completed or were terminated, 18 (45%) have results posted.
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2 of 72 have an industry lead sponsor. The 10 most frequent:
Johns Hopkins Bloomberg School of Public Health is the lead sponsor of 371 studies on the registry; 41 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Johns Hopkins Bloomberg School of Public Health has 4 studies filed under Drug Overdose — fewer than ten, so there is no comparison to draw.
8 of the studies in Drug Overdose with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07022717Boston Medical CenterA Universal Primary Care Based Intervention to Reduce Youth Overdose Risk | 2026-11 |
| NCT05320835Johns Hopkins Bloomberg School of Public HealthA Setting Focus Overdose Prevention Intervention | 2026-12-01 |
| NCT06236087NYU Langone HealthOverdose Prevention Centers and Behavioral Health | 2026-12-31 |
| NCT07170072NYU Langone HealthShelter HArm Reduction Evaluation | 2027-03-31 |
| NCT05657106April M YoungKentucky Outreach Service Kiosk (KyOSK): Reducing HIV, HCV, and Overdose Risk | 2027-05-31 |
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Among the 72 studies in Drug Overdose with a site in United States, from their registry updates:
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The purpose of this study is to pilot and implement a peer mentor intervention focused on overdose prevention and care.
The intervention consists of 3 sessions. During the first and second session, each participant will meet individually with a trained staff member. In the 3rd session, the participant will invite a social network member to attend the session, and these 2 participants will meet with a trained staff member.
The specific aims of the study are:
There are two types of participants: Index participants and network participants. Both type of participant will currently used opiates. Participants will take part in a baseline visit and up to 3 follow-up visits. Index participants will be randomized into the intervention or control arm of the study.
Inclusion Criteria for Index participants:
Inclusion Criteria for network participants:
Exclusion Criteria:
* During Session 1, participants will be trained in Peer Education and how to use Nasal Narcan. They will be given two Nasal Narcan kit that includes 2 doses. One kit if for their use and one kit is to give someone in their social network after they have trained them in how to use it. * A week after Session 1, participants will be scheduled for Session 2. * During session 1 and 2 participants, Index participants will be taught information and skills pertaining to overdose prevention and response and how to train network members in overdose prevention and response. * At the 2nd session, index participants will be given 1 coupon to give to 1 member from their social network to attend Session 3. * Session 3 will be a dyad session where Index participants will use their peer mentors' skills to train their network member in overdose prevention and response. * Index participants will also be invited to up to 3 Booster Session (monthly) after they complete Sessions 1-3.
Behavioral: Peer Education · Drug: Narcan Nasal Product
* Participants randomized to this condition will participate in one 1-hour session. This session will be an individual session where the participant will meet with a trained staff member in a private room at the Lighthouse. * This session will be standard overdose prevention and response information. Participants will also be trained in Narcan administration. Participants will be given 1 nasal Narcan kit. * At the end of this session, participants will be asked to refer a network member to the study for survey visits
Drug: Narcan Nasal Product
In this intervention, people who use opiates will be trained to be peer educators.
Also known as: Experimental arm
All study participants will be trained in how to use nasal Narcan and they will receive a nasal Narcan kit.
Network Enrollment
The question will be: How many people in their social network did Index participants recruit to the study? Participants provide a number of 0 or higher.
Time frame: 6 months
Drug treatment entry
The question will be: In the past 12 months, did you enroll in a drug treatment program including a medically assisted treatment program? The response options are yes and no.
Time frame: 12 months
Overdose Risk
Change in risk will be measured by a score that includes frequency of naloxone availability when using opiates, testing drugs before injecting, and drug use alone. Higher scores will indicate increased overdose risk. Scores will be measured from 0-9
Time frame: 12 months
Ran from Mar 2019 to primary completion in Dec 2023, 57 months.
Of 47 non-industry interventional studies with no phase under Drug Overdose, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 49. This study's 57 months is above that.
Counting every sponsor, half of 47 studies reached it within 31 months; a quarter within 13 and three quarters within 49.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Johns Hopkins Bloomberg School of Public Health →