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

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ClinicalTrials.gov Identifier: NCT03502525
Recruitment Status : Recruiting
First Posted : April 18, 2018
Last Update Posted : May 24, 2018
Sponsor:
Collaborators:
University of Tartu
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

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.

Condition or disease Intervention/treatment Phase
Substance Abuse, Intravenous Prevention and Control Behavioral: Break the Cycle Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Break the Cycle: Adapting Break the Cycle to Reduce Initiation Into Injecting Drug Use in Tallinn, Estonia and New York City, USA
Actual Study Start Date : August 31, 2016
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Arm Intervention/treatment
Experimental: Break the Cycle Intervention
All study participants are assigned to this experimental arm.
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Number of participants who say positive things [ Time Frame: 6 months ]
    Number of participants who saying positive things about injecting to persons who do not inject drugs

  2. Number of participants injecting in front of other people [ Time Frame: 6 months ]
    Number of participants injecting in front of people who do not inject drugs

  3. Number of participants offering to give first injection [ Time Frame: 6 months ]
    Number of participants offering to give a first injection to persons who do not inject drugs



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03502525


Contacts
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Contact: David M. Barnes, PhD 212-256-2594 david.barnes@mountsinai.org

Locations
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United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: David M. Barnes, PhD    212-256-2594    david.barns@mountsinai.org   
Estonia
University of Tartu Recruiting
Tallinn, Estonia
Contact: Ave Talu, MS       ave.talu@gmail.com   
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
University of Tartu
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Don Des Jarlais, PhD Icahn School of Medicine at Mount Sinai
Principal Investigator: Anneli Uuskula, PhD University of Tartu

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Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03502525     History of Changes
Other Study ID Numbers: GCO 15-1445
5DP1DA039542-05 ( U.S. NIH Grant/Contract )
First Posted: April 18, 2018    Key Record Dates
Last Update Posted: May 24, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Substance-Related Disorders
Substance Abuse, Intravenous
Chemically-Induced Disorders
Mental Disorders