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.
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
- Conditions the study is for
- Substance Abuse, Intravenous, Prevention and Control
- What is being tested?
- Break the Cycle Intervention and Bacterial Infection Prevention
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- 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
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 group | Role | What they receive |
|---|---|---|
| Break the Cycle Intervention | Experimental | Break 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 Prevention | Active comparator | 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. Receives: Behavioral: Bacterial Infection Prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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.
- First posted18 Apr 2018
- Study start31 Aug 2016
- Primary completion1 Apr 2019
- Study completion2 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Abuse, IntravenousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tartu, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Don Des Jarlais, PhD, Principal investigator, New York UniversityAnneli Uuskula, PhD, Principal investigator, University of Tartu
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
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Break the Cycle: Adapting Break the Cycle to Reduce Initiation Into Injecting Drug Use in Tallinn, Estonia and New York City, USA
- ClinicalTrials.gov ID
- NCT03502525
- Acronym / sponsor ID
- GCO 15-1445
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 402 participants (actual)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Collaborators
- University of Tartu, National Institute on Drug Abuse (NIDA)
- Study start
- 31 Aug 2016 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 2 Sep 2022 (actual)
- First posted
- 18 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Break the Cycle Intervention | Experimental | Behavioral: Break the Cycle InterventionBreak the Cycle intervention uses motivational interviewing to enhance current injectors' motivation and skills to avoid helping with and promoting first injections among non-PWID. |
| Bacterial Infection Prevention | Active comparator | Behavioral: Bacterial Infection PreventionBacterial 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Break the Cycle InterventionThe 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. | Behavioural | Break the Cycle Intervention |
| Bacterial Infection PreventionBacterial 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. | Behavioural | Bacterial Infection Prevention |
Primary outcome
Number of participants helping with first injections
Time frame: 6 months
Number of participants who helped persons who do not inject drugs with a first injection
3 secondary outcomes
Number of participants who say positive things
Time frame: 6 months
Number of participants injecting in front of other people
Time frame: 6 months
Number of participants offering to give first injection
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Individual participant dataSharing planned: No
Related trials for Substance Abuse, Intravenous
Active, not recruiting
Implementing PrEP for Women Who Inject Drugs
HIV, Intravenous Substance Abuse
Active, not recruiting
Kentucky Outreach Service Kiosk (KyOSK): Reducing HIV, HCV, and Overdose Risk
Opioid-Related Disorders, Hepatitis C (HCV)
Enrolling by invitationObservational study
Histiocytosis in Injecting Drug Users
Histiocytosis
RecruitingObservational study
A Cross-Sectional Observational Study on Retained Drug Needle Fragments in People Who Use Intravenous Drugs
Drug Abuse, Intravenous, Substance Dependence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Don Des Jarlais, PhD principal investigator
New York University
Anneli Uuskula, PhD principal investigator
University of Tartu
2 sites in 2 countries: see every site and its status.
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.