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NCT03502525 · ClinicalTrials.gov registry record · NA

Break the Cycle: Prevention for Reducing Initiation Into Injection Drug Use

A NA study, sponsored by New York University.

Completed
Registry status
NA
Development phase
402
Enrollment target

NCT03502525: Completed NA study, sponsored by New York University.

NCT03502525 is a NA study that has completed, run by New York University. The registered enrollment target is 402 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03502525, a NA study, has completed, sponsored by New York University.

COMPLETED
Registry status
NA
Development phase
402 participants
Enrollment target

Study Summary

Break the Cycle is a two-session, one-on-one, in-person intervention study designed to reduce the role persons who inject drugs (PWID) play initiating non-PWID into injection drug use. Study implementation is at two sites: New York City and Tallinn, Estonia. At baseline, quantitative data are collected via a structured computer-assisted personal interview, after which the intervention is conducted. At the 6-month follow-up, a modified version of the interview is repeated. In Tallinn, and in it's first iteration in NYC, Break the Cycle used a pre- versus post- design to compare the proportion of participants who helped with first injections, and who promoted injecting among non-PWID, in the 6 months prior to baseline with the proportions at the 6-month follow-up. Based on previous research on the intervention and on the underlying theory of motivational interviewing, increases in helping and promoting behaviors between baseline and follow-up would indicate that the intervention was not effective regardless of their effect size. Accordingly, the hypotheses that the intervention will produce reductions in assisting with first injections and engaging in injection promoting behaviors will be evaluated using one-tailed statistical tests. Break the Cycle intervention follows a motivational interviewing approach to enhance current injectors' motivation and skills to avoid helping with and promoting first injections among non-PWID. The intervention's core is a discussion between an interventionist and each participant on the following eight topics: the participant's first time injecting drugs; the participant's exposures to situations where helping with others' first injections is an option, and the extent to which they have helped; PWIDs' behaviors that might encourage non-PWID to inject for the first time; the range of risks associated with injection drug use; role-playing scenarios in which the participant develops behaviors and scripts for avoiding or refusing requests

Primary Outcome

Number of participants who helped persons who do not inject drugs with a first injection

Interventions

  • BEHAVIORAL Break the Cycle Intervention
  • BEHAVIORAL Bacterial Infection Prevention

Trial Details

FieldValue
Enrollment Target 402 participants
Start Date 2016-08-31
Est. Completion 2022-09-02
Phase NA
New York University

83 total trials

What the finished NCT03502525 record still lists

NCT03502525 is an interventional study that assigns participants to a tested intervention. The registered 402 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (71% lower).

The record links to 0 conditions, and to 2 interventions - of which Break the Cycle Intervention is the first listed.

NCT03502525 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03502525 about?

NCT03502525 is a clinical study titled "Break the Cycle: Prevention for Reducing Initiation Into Injection Drug Use". Break the Cycle is a two-session, one-on-one, in-person intervention study designed to reduce the role persons who inject drugs (PWID) play initiating non-PWID into injection drug use. Study implementation is at two sites: New York City and Tallinn, Estonia. At baseline, quantitative data are collec...

What is the current status of trial NCT03502525?

This trial is currently completed. It is a NA study. The enrollment target is 402 participants. The study started on 2016-08-31. Estimated completion is 2022-09-02.

What interventions are being tested in trial NCT03502525?

The interventions under investigation include: Break the Cycle Intervention (BEHAVIORAL), Bacterial Infection Prevention (BEHAVIORAL).

Who is sponsoring clinical trial NCT03502525?

This trial is sponsored by New York University, which has 83 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03502525's enrollment target sits among peer trials

402 245th of 2000 higher than 1,755 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03502525, the US trial registry maintained by the National Library of Medicine. NCT03502525 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.