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OD training + mobile PI intervention for Opioid Use Disorder

N/A
Waitlist Available
Led By Michelle Acosta
Research Sponsored by National Development and Research Institutes, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study Summary

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in opioid use
Change in self-reported injection status via Timeline Followback
Secondary outcome measures
Change in HIV/HCV risk behavior
OD
Peer IDU norms

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: OD training + mobile PI interventionExperimental Treatment1 Intervention
Participants will complete the same baseline assessment and OD training (plus naloxone) as those in the first condition. Participants also will receive mobile phones pre-loaded with the PI App and will be sent daily prompts. As part of the PI App, participants will be asked to share information about avoiding problems associated with opioid use with peers in their social network, and to encourage their peers to download the PI App for their own use.
Group II: OD prevention/response trainingActive Control1 Intervention
Immediately following the baseline assessment, trained research staff will conduct a brief (20 min.) OD training with each participant. Participants will be asked to view the NYC Department of Health and Mental Hygiene's 13-minute OD prevention and response training video (available online free-of-charge). Following the video, research staff will review key information, answer any questions participants may have, demonstrate assembly of the intranasal naloxone atomizer and ensure participants are able to execute this assembly procedure. A prescription for naloxone, as well as a standard naloxone kit containing two doses of the medication and atomizers for intranasal administration, will be given to participants, along with printed literature reviewing key training information.

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Who is running the clinical trial?

National Development and Research Institutes, Inc.Lead Sponsor
37 Previous Clinical Trials
12,882 Total Patients Enrolled
Michelle AcostaPrincipal InvestigatorNIDA/NIH

Frequently Asked Questions

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~8 spots leftby Apr 2025