search
Back to results

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

Primary Purpose

Substance Abuse, Intravenous, Prevention and Control

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Break the Cycle Intervention
Sponsored by
New York University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Substance Abuse, Intravenous

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York UniversityRecruiting
  • University of TartuRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Break the Cycle Intervention

Arm Description

All study participants are assigned to this experimental arm.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of participants who say positive things
Number of participants who saying positive things about injecting to persons who do not inject drugs
Number of participants injecting in front of other people
Number of participants injecting in front of people who do not inject drugs
Number of participants offering to give first injection
Number of participants offering to give a first injection to persons who do not inject drugs

Full Information

First Posted
April 11, 2018
Last Updated
February 25, 2020
Sponsor
New York University
Collaborators
University of Tartu, National Institute on Drug Abuse (NIDA)
search

1. Study Identification

Unique Protocol Identification Number
NCT03502525
Brief Title
Break the Cycle: Prevention for Reducing Initiation Into Injection Drug Use
Official Title
Break the Cycle: Adapting Break the Cycle to Reduce Initiation Into Injecting Drug Use in Tallinn, Estonia and New York City, USA
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 31, 2016 (Actual)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York University
Collaborators
University of Tartu, National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse, Intravenous, Prevention and Control

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Break the Cycle Intervention
Arm Type
Experimental
Arm Description
All study participants are assigned to this experimental arm.
Intervention Type
Behavioral
Intervention Name(s)
Break the Cycle Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants helping with first injections
Description
Number of participants who helped persons who do not inject drugs with a first injection
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of participants who say positive things
Description
Number of participants who saying positive things about injecting to persons who do not inject drugs
Time Frame
6 months
Title
Number of participants injecting in front of other people
Description
Number of participants injecting in front of people who do not inject drugs
Time Frame
6 months
Title
Number of participants offering to give first injection
Description
Number of participants offering to give a first injection to persons who do not inject drugs
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David M. Barnes, PhD
Phone
212-992-3729
Email
barned05@nyu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Don Des Jarlais, PhD
Organizational Affiliation
New York University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anneli Uuskula, PhD
Organizational Affiliation
University of Tartu
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University
City
New York
State/Province
New York
ZIP/Postal Code
10012
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David M. Barnes, PhD
Phone
212-992-3729
Email
barned05@nyu.edu
Facility Name
University of Tartu
City
Tallinn
Country
Estonia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ave Talu, MS
Email
ave.talu@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs