Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06327061
Other study ID # R01DA058659
Secondary ID IRB00026607
Status Recruiting
Phase N/A
First received
Last updated
Start date May 1, 2024
Est. completion date December 1, 2027

Study information

Verified date June 2024
Source Johns Hopkins Bloomberg School of Public Health
Contact Carl Latkin, PhD
Phone (410)955-3972
Email carl.latkin@jhu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to test a social intervention focused on overdose prevention and care. In the investigators prior work, the investigators have shown that people who use opioids (PWUO) can be effective peer educators (PEs).


Description:

The purpose of this study is to test a social intervention focused on overdose prevention and care. In the investigators prior work, the investigators have shown that people who use opioids (PWUO) can be effective peer educators (PEs). The investigators have utilized PEs for overdose prevention in interventions that have focused on training network members who use drugs to respond to an overdose. Yet, many overdoses are witnessed by people who do not use drugs. Additionally, many PWUO report using drugs at home and living with someone who does not use drugs, which highlights the importance of training non-using network members on overdose response. Based on pilot data, the investigators propose expanding an overdose peer education intervention to focus on non-using network members. The intervention seeks to prepare network members to respond to an overdose and normalize discussions about overdose prevention planning between index PWUO and non-using network members. The intervention condition consists of 3 individual sessions focused on overdose prevention and response. This condition is designed to train index study participants to be Peer Educators. In addition to the three sessions, the non-drug using network member will be offered one session. The control condition is only 1 session focused on overdose prevention and response. Both intervention and control participants will invite social network members to take part in data collection activities


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date December 1, 2027
Est. primary completion date June 1, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - self-reported illicit opioid use at least 2 times in the past two weeks; - age 18 and older; - living in the Baltimore metropolitan region; - willing to engage in peer education; and - having and willing to recruit at least one non-using network member. Exclusion Criteria: Participants without the cognitive ability to provide informed consent and have the physical ability to participate in in-person intervention sessions.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Network overdose prevention
Participants are taught overdose prevention methods with network members.
Standard of care health education
Participants will receive the standard of care for overdose prevention.

Locations

Country Name City State
United States Johns Hopkins Bloomberg School of Public Health Baltimore Maryland

Sponsors (2)

Lead Sponsor Collaborator
Johns Hopkins Bloomberg School of Public Health National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of drug overdoses Number of drug overdoses in prior three months 3-months
Primary Participant drug use Proportion of times participants tested positive for drugs of fentanyl and xylazine using test strips in the prior 3 months. 3-months
Secondary Number of Network member contacts Number of network members talked to about overdose prevention in prior 3 months 3-months
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04070521 - EEG Monitoring in the Emergency Department
Completed NCT04372238 - The Rhode Island Prescription and Illicit Drug Study N/A
Withdrawn NCT04391192 - Virtual Overdose Response N/A
Completed NCT02924454 - Effects of Lipid Emulsion on the Pharmacokinetic and Pharmacodynamic Properties of Metoprolol. Phase 4
Completed NCT02282306 - Phone Interview to Prevent Recurring Opioid Overdoses N/A
Not yet recruiting NCT01912573 - Nasal Naloxone for Narcotic Overdose Phase 4
Completed NCT04091659 - Use of Virtual Reality for Overdose Management Educational Trainings N/A
Recruiting NCT05517668 - Evaluation of the Efficacy of Fomepizole in the Treatment of Acetaminophen Overdose Phase 2
Completed NCT02572089 - Pharmacokinetic Evaluation of Intranasal and Intramuscular Naloxone in Healthy Volunteers Phase 1
Completed NCT02152397 - Safety and Health Intervention Project N/A
Active, not recruiting NCT05096429 - Preventing Overdose Using Information and Data From the Environment N/A
Recruiting NCT03845699 - Development of an Algorithm That Predicts Hypoventilation Due to an Opioid Overdose
Completed NCT03840018 - Effectiveness of a Postal Intervention to Improve the Use of PPI N/A
Completed NCT03087149 - Monitored vs Standard Supplementation of Vitamin D in Preterm Infants N/A
Active, not recruiting NCT05657106 - Kentucky Outreach Service Kiosk (KyOSK): Reducing HIV, HCV, and Overdose Risk N/A
Completed NCT02598856 - Bioavailability of Nasal Naloxone and Injected Naloxone Compared Phase 1
Completed NCT02158117 - Bioavailability of a New Formulation of Nasal Naloxone for Prehospital Use Phase 1
Recruiting NCT05146336 - CytOSorb TreatMent Of Critically Ill PatientS Registry
Not yet recruiting NCT02733822 - Buccal Versus Injectable Naloxone: a Phase I Healthy Volunteer Study Phase 1
Active, not recruiting NCT05308303 - AI to Improve Data From Danish Cardiac Arrest Registry