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Not listed Not applicable Interventional Accepts healthy volunteers

Mobile Intervention for Young Opioid Users

ClinicalTrials.gov ID: NCT03610672

Public ClinicalTrials.gov record NCT03610672. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 8, 2026, 3:41 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Preventing Injection: An mHealth Intervention That Leverages Social Networks to Prevent Progression to Injection Among Young Opioid Users

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Opioid use disorders (OUD) are the second most common type of drug use disorder in the US, with nearly 2 million Americans with prescription opioid- (PO) and \~570,000 with heroin-related OUD. The escalation in OUD during the past two decades has been most pronounced among youth, many of whom demonstrate a rapid transition from nonmedical PO use (16-17 y/o), to heroin (19-20 y/o), with most progressing to injection drug use (IDU), within a year of starting heroin use (20-21 y/o). Progression to IDU is characterized by uniquely high levels of risk for youth, including higher rates of overdose (OD) and HIV and HCV incidence, compared to older peers. Addiction severity, psychosocial functioning, and social networks are robust predictors of transitioning to IDU; however there is virtually no research on how to prevent or halt this transition to IDU. Given the paucity of interventions targeting this large and vulnerable group of youth, we propose to adapt and evaluate an innovative, engaging mHealth intervention to prevent young opioid users (18-29) from transitioning to IDU. Aim 1: During months 1-12, we will adapt our existing mobile intervention for OUD that includes daily text messages plus key components of evidence-based CBT interventions, including Functional Analysis of Drug Use, Self-Management, and Social / Recreational Counseling. New components specific to youth will focus on the role of peers on opioid use and IDU, and OD prevention / response training. Our iterative development process will include focus groups with opioid-using youth (n=24), interviews with important stakeholders (e.g., youth treatment providers; n=6), and feedback and usability data from opioid-using youth (n=30). Aim 2: During months 13-31, we will conduct a small randomized, controlled trial of the tailored mHealth intervention with young opioid users who have not transitioned to regular injection (n=64) and compare (1) assessment plus in-person OD prevention / response training (including naloxone) versus (2) assessment plus in-person OD prevention / response training (including naloxone) plus our mHealth intervention. Feasibility and acceptability will be assessed via participant feedback, retention, and usage data. Diffusion will be defined as the number of participants' peers who download the intervention app for their own use. Preliminary effectiveness will be measured via reductions in opioid use (TLFB, urine / hair toxicology) and self-reported injection status at 4, 8, and 12 weeks, and 3 and 6 month follow-up. Secondary outcomes include HIV/HCV risk behavior, OD, opioid-related problems (e.g., withdrawal episodes), and social network IDU-related norms and behaviors. If results are promising, this novel intervention will be expanded for examination in a large-scale efficacy / effectiveness trial.

Study identification

NCT ID
NCT03610672
Recruitment status
Not listed
Study type
Interventional
Phase
Not applicable
Enrollment
64 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 29 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 14, 2017
Primary completion
Nov 27, 2019
Completion
Feb 27, 2020
Last update posted
Aug 1, 2018

2017 – 2020

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
National Development and Research Institutes, Inc. New York New York 10010 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03610672, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 1, 2018 · Synced Sep 8, 2026

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The complete protocol, eligibility criteria, and contact information for NCT03610672 live on ClinicalTrials.gov.

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