OverdoseNCT04212364
An Evaluation of a Social Network Intervention for Primary and Secondary Prevention of Opioid Overdoses
A study testing Peer Education and Narcan Nasal Product in people with Overdose, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overdose
- What is being tested?
- Peer Education and Narcan Nasal Product
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 614 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2019to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- self-reported use of opiates including heroin, fentanyl, or prescription opiates to get high at least 2 times in the last two weeks;
- willing to invite a network member who uses drugs to the study;
- ages 18-years or older;
- living in the Baltimore metropolitan region, and
- not previously enrolled in the study or currently enrolled in another Lighthouse study.
- self-reported use of illicit injecting or non-injecting opiates at least 2 times in the last two weeks;
Show all 9Show fewer
- sees the Index participant 2 or more times in the past week;
- ages 18 years or older; and
- living in the Baltimore metropolitan region.
Who cannot join
- Index participants may not take part in the study as a Network participant.
- Network participants may not take part in the study as an Index participant.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lighthouse Studies at Peer Point
Baltimore, Maryland, 21205
About this study
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.
Read the detailed description
The specific aims of the study are:
- Conduct a pilot of an HIV/HCV/overdose prevention and care intervention for people who use opiates.
- Evaluate the feasibility of collecting donated drug preparation containers (i.e., cookers) to assess the presence of fentanyl, HCV, and HIV.
- Conduct a randomized controlled trial to assess efficacy of the experimental Peer Mentor condition on (a) overdose prevention and care education to drug network members, (b) naloxone availability, and (c) drug treatment readiness and entry.
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.
- Conditions
- Overdose
- Being tested
- Peer Education, Narcan Nasal Product
- Keywords
- peer education, social networks
- Medical subject headings
- Drug Overdose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer EducationBehavioural
Also called Experimental arm
In this intervention, people who use opiates will be trained to be peer educators.
Narcan Nasal ProductDrug
All study participants will be trained in how to use nasal Narcan and they will receive a nasal Narcan kit.
| Study group | Role | What they receive |
|---|---|---|
| Peer Education | Experimental | * 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. Receives: Behavioral: Peer Education; Drug: Narcan Nasal Product |
| Standard of care | Active comparator | * 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 Receives: Drug: Narcan Nasal Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (2)
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.
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2019
- Study start15 Mar 2019
- Primary completion29 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverdoseStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe 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
- Parallel groups
- Model description
- Index participants will be randomized into 1 of two study arms.
- Masking
- None (open label)
- Enrolment
- 614 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Carl A. Latkin, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04212364
- Sponsor's protocol ID
- 1R01CE003021
- Status last verified
- Jan 2024
- First submitted
- 27 Aug 2019
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of a Social Network Intervention for Primary and Secondary Prevention of Opioid Overdoses
- ClinicalTrials.gov ID
- NCT04212364
- Acronym / sponsor ID
- 1R01CE003021
- Conditions
- Overdose
- Keywords
- peer education, social networks
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 614 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 29 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 27 Dec 2019 (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.
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.
Detailed description
The specific aims of the study are:
- Conduct a pilot of an HIV/HCV/overdose prevention and care intervention for people who use opiates.
- Evaluate the feasibility of collecting donated drug preparation containers (i.e., cookers) to assess the presence of fentanyl, HCV, and HIV.
- Conduct a randomized controlled trial to assess efficacy of the experimental Peer Mentor condition on (a) overdose prevention and care education to drug network members, (b) naloxone availability, and (c) drug treatment readiness and entry.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Index participants will be randomized into 1 of two study arms.
| Arm | Type | Receives |
|---|---|---|
| Peer Education | Experimental | Behavioral: Peer Education, Drug: Narcan Nasal Product* 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. |
| Standard of care | Active comparator | 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- self-reported use of opiates including heroin, fentanyl, or prescription opiates to get high at least 2 times in the last two weeks;
- willing to invite a network member who uses drugs to the study;
- ages 18-years or older;
- living in the Baltimore metropolitan region, and
- not previously enrolled in the study or currently enrolled in another Lighthouse study.
Key exclusion criteria (2 listed)
- Index participants may not take part in the study as a Network participant.
- Network participants may not take part in the study as an Index participant.
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 |
|---|---|---|
| Peer EducationAlso: Experimental armIn this intervention, people who use opiates will be trained to be peer educators. | Behavioural | Peer Education |
| Narcan Nasal ProductAll study participants will be trained in how to use nasal Narcan and they will receive a nasal Narcan kit. | Drug | Peer Education, Standard of care |
Primary outcome
Network Enrollment
Time frame: 6 months
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.
2 secondary outcomes
Drug treatment entry
Time frame: 12 months
Overdose Risk
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
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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. This study is not recruiting at the moment.
Carl A. Latkin, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer Education and Narcan Nasal Product in people with Overdose, run by Johns Hopkins Bloomberg School of Public Health at 1 site 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 9 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 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Network Enrollment (time frame: 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 24 Jan 2024.