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

Substance Abuse, Intravenous Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03502525
• Other study ID #: GCO 15-1445
• Secondary ID: 5DP1DA039542-05
• Status: Recruiting
• Phase: N/A
• Start date: August 31, 2016
• Est. completion date: June 2021

Study information

• Verified date: February 2020
• Source: New York University
• Contact: David M. Barnes, PhD
• Phone: 212-992-3729
• Email: barned05[@]nyu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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. The study uses 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Prevention and Control
• Substance Abuse, Intravenous
• Substance-Related Disorders

Intervention

Behavioral:
• Break the Cycle Intervention
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.

Locations

Country	Name	City	State
Estonia	University of Tartu	Tallinn
United States	New York University	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
New York University	National Institute on Drug Abuse (NIDA), University of Tartu

Countries where clinical trial is conducted

United States,  Estonia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants helping with first injections	Number of participants who helped persons who do not inject drugs with a first injection	6 months
Secondary	Number of participants who say positive things	Number of participants who saying positive things about injecting to persons who do not inject drugs	6 months
Secondary	Number of participants injecting in front of other people	Number of participants injecting in front of people who do not inject drugs	6 months
Secondary	Number of participants offering to give first injection	Number of participants offering to give a first injection to persons who do not inject drugs	6 months