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Substance Abuse, IntravenousNCT03502525

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

A study testing Break the Cycle Intervention and Bacterial Infection Prevention in people with Substance Abuse, Intravenous and Prevention and Control, run by New York University at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Break the Cycle Intervention and Bacterial Infection Prevention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
402 participants
Where
2 sitesin 2 countries
Study dates
31 Aug 2016to 2 Sep 2022
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • have injected drugs non-medically in the last 2 months
  • able to provide informed consent
  • age 18 or older
  • able to participate in the interview and intervention in English (in New York City), Russian or Estonian (in Tallinn, Estonia)

Who cannot join

  • none

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site
  • New York University

    New York, New York, 10012

Other trials in United States

Estonia1 site
  • University of Tartu

    Tallinn

Other trials in Estonia

About this study

Official title: Break the Cycle: Adapting Break the Cycle to Reduce Initiation Into Injecting Drug Use in Tallinn, Estonia and New York City, USA

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 to initiate others into injection drug use; role- playing talking with other PWID about not encouraging non-PWID to start injecting; imparting safer injection practices when helping with a first injection seems like the best option; and receiving training in and using Narcan to reverse overdoses.

Read more

In the second iteration of Break the Cycle in New York City, a second arm to the trial was added: an attentional control intervention, Bacterial Infection Prevention. The content of Bacterial Infection Prevention is representative of the infection prevention information injection drug users ought to receive, and sometimes do, when they engage with service providers, such as syringe exchange programs. Bacterial Infection Prevention does not use Motivational Interviewing principles, but is more informational/educational in nature. This intervention focuses on bacterial infection risks that accompany injection drug use, with a special focus on risk reduction, identification, and treatment of abscesses and endocarditis. Participants eligible for Break the Cycle are randomized to either receive the Break the Cycle intervention or the Bacterial Infection Prevention intervention. Enrollment in this iteration ended in March 2020, with the advent of the Covid pandemic in the United States.

The third iteration of the Break the Cycle intervention in New York City will transform the second iteration into a phone-based study in which both Break the Cycle and Bacterial Infection Prevention are delivered to participants over the telephone. Both interventions have been slightly abbreviated to adjust to phone delivery. This iteration will commence in early spring, 2021.

Being tested
Break the Cycle Intervention, Bacterial Infection Prevention
Medical subject headings
Substance Abuse, Intravenous

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Break the Cycle InterventionBehavioural

    The intervention uses motivational interviewing to enhance persons who inject drugs' (PWID) motivation and skills to avoid helping non-PWID transition to injecting. The intervention entails discussions with participants in 8 areas: the participant's first time injecting; the participant's exposures to situations where helping with non-PWIDs' first injections is an option, and the extent to which they helped; their behaviors that might encourage non-PWID to inject for the first time; the risks associated with injection drug use; role-playing in which participants develop behaviors and scripts for avoiding or refusing requests to initiate non-PWID into injection; role- playing talking with other PWID about not encouraging non-PWID to start injecting; imparting safer injection practices when helping with a first injection seems like the best option; and receiving training in and using naloxone to reverse overdoses.

  • Bacterial Infection PreventionBehavioural

    Bacterial Infection Prevention is an attention control intervention. The content of Bacterial Infection Prevention is representative of the infection prevention information injection drug users ought to receive, and sometimes do, when they engage with service providers, such as syringe exchange programs. Bacterial Infection Prevention does not use Motivational Interviewing principles, but is more informational/educational in nature. This intervention focuses on bacterial infection risks that accompany injection drug use, with a special focus on risk reduction, identification, and treatment of abscesses and endocarditis.

Study groups in NCT03502525
Study groupRoleWhat they receive
Break the Cycle InterventionExperimentalBreak the Cycle intervention uses motivational interviewing to enhance current injectors' motivation and skills to avoid helping with and promoting first injections among non-PWID.
Receives: Behavioral: Break the Cycle Intervention
Bacterial Infection PreventionActive comparatorBacterial Infection Prevention is an attention control intervention. The content of Bacterial Infection Prevention is representative of the infection prevention information injection drug users ought to receive, and sometimes do, when they engage with service providers, such as syringe exchange programs. Bacterial Infection Prevention does not use Motivational Interviewing principles, but is more informational/educational in nature. This intervention focuses on bacterial infection risks that accompany injection drug use, with a special focus on risk reduction, identification, and treatment of abscesses and endocarditis.
Receives: Behavioral: Bacterial Infection Prevention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants helping with first injections

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

    Measured: 6 months

Secondary outcomes (3)
  1. Number of participants who say positive things

    Number of participants who saying positive things about injecting to persons who do not inject drugs

    Measured: 6 months

  2. Number of participants injecting in front of other people

    Number of participants injecting in front of people who do not inject drugs

    Measured: 6 months

  3. Number of participants offering to give first injection

    Number of participants offering to give a first injection to persons who do not inject drugs

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2018
  2. Study start31 Aug 2016
  3. Primary completion1 Apr 2019
  4. Study completion2 Sep 2022

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
In the second and third iterations of the study in New York City, participants are randomized to either Break the Cycle or an attention control intervention.
Masking
None (open label)
Enrolment
402 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03502525
Sponsor's protocol ID
GCO 15-1445
Other IDs
5DP1DA039542-05
Status last verified
Feb 2020
First submitted
11 Apr 2018
Last updated
25 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Break the Cycle Intervention and Bacterial Infection Prevention in people with Substance Abuse, Intravenous and Prevention and Control, run by New York University at 2 sites in 2 countries.

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 4 inclusion and 1 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 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Estonia. 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?

Number of participants helping with first injections (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 25 May 2025.

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