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Mobile Intervention for Young Opioid Users

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ClinicalTrials.gov Identifier: NCT03610672
Recruitment Status : Unknown
Verified July 2018 by National Development and Research Institutes, Inc..
Recruitment status was:  Recruiting
First Posted : August 1, 2018
Last Update Posted : August 2, 2018
Sponsor:
Information provided by (Responsible Party):
National Development and Research Institutes, Inc.

Brief Summary:
Opioid use disorders (OUD) are the second most common type of drug use disorder in the US, with nearly 2 million Americans with prescription opioid- (PO) and ~570,000 with heroin-related OUD. The escalation in OUD during the past two decades has been most pronounced among youth, many of whom demonstrate a rapid transition from nonmedical PO use (16-17 y/o), to heroin (19-20 y/o), with most progressing to injection drug use (IDU), within a year of starting heroin use (20-21 y/o). Progression to IDU is characterized by uniquely high levels of risk for youth, including higher rates of overdose (OD) and HIV and HCV incidence, compared to older peers. Addiction severity, psychosocial functioning, and social networks are robust predictors of transitioning to IDU; however there is virtually no research on how to prevent or halt this transition to IDU. Given the paucity of interventions targeting this large and vulnerable group of youth, we propose to adapt and evaluate an innovative, engaging mHealth intervention to prevent young opioid users (18-29) from transitioning to IDU. Aim 1: During months 1-12, we will adapt our existing mobile intervention for OUD that includes daily text messages plus key components of evidence-based CBT interventions, including Functional Analysis of Drug Use, Self-Management, and Social / Recreational Counseling. New components specific to youth will focus on the role of peers on opioid use and IDU, and OD prevention / response training. Our iterative development process will include focus groups with opioid-using youth (n=24), interviews with important stakeholders (e.g., youth treatment providers; n=6), and feedback and usability data from opioid-using youth (n=30). Aim 2: During months 13-31, we will conduct a small randomized, controlled trial of the tailored mHealth intervention with young opioid users who have not transitioned to regular injection (n=64) and compare (1) assessment plus in-person OD prevention / response training (including naloxone) versus (2) assessment plus in-person OD prevention / response training (including naloxone) plus our mHealth intervention. Feasibility and acceptability will be assessed via participant feedback, retention, and usage data. Diffusion will be defined as the number of participants' peers who download the intervention app for their own use. Preliminary effectiveness will be measured via reductions in opioid use (TLFB, urine / hair toxicology) and self-reported injection status at 4, 8, and 12 weeks, and 3 and 6 month follow-up. Secondary outcomes include HIV/HCV risk behavior, OD, opioid-related problems (e.g., withdrawal episodes), and social network IDU-related norms and behaviors. If results are promising, this novel intervention will be expanded for examination in a large-scale efficacy / effectiveness trial.

Condition or disease Intervention/treatment Phase
Opioid-Related Disorders Behavioral: OD prevention/response training Behavioral: OD prevention/response training + PI mobile application Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: The current study is a two-armed, open randomized clinical trial design.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preventing Injection: An mHealth Intervention That Leverages Social Networks to Prevent Progression to Injection Among Young Opioid Users
Actual Study Start Date : September 15, 2017
Estimated Primary Completion Date : November 28, 2019
Estimated Study Completion Date : February 28, 2020

Arm Intervention/treatment
Active Comparator: OD prevention/response training
Immediately following the baseline assessment, trained research staff will conduct a brief (20 min.) OD training with each participant. Participants will be asked to view the NYC Department of Health and Mental Hygiene's 13-minute OD prevention and response training video (available online free-of-charge). Following the video, research staff will review key information, answer any questions participants may have, demonstrate assembly of the intranasal naloxone atomizer and ensure participants are able to execute this assembly procedure. A prescription for naloxone, as well as a standard naloxone kit containing two doses of the medication and atomizers for intranasal administration, will be given to participants, along with printed literature reviewing key training information.
Behavioral: OD prevention/response training
Participants will view a 13-minute OD prevention and response training video (available online free-of-charge). This video covers NY State's recommended curriculum for Overdose Prevention: how to prevent, identify, and respond to an OD, including information on the factors that could heighten risk for overdose (mixing drugs, changes in tolerance and drug purity, and using alone), how to respond to an overdose (rescue breathing, calling 911), and specific instructions on how and when to administer naloxone to someone who is overdosing. After the video, research staff will review key information, answer any questions participants may have, demonstrate assembly of the intranasal naloxone atomizer and ensure participants are able to assemble it. A prescription for naloxone, as well as a standard naloxone kit containing two doses of the medication and atomizers for intranasal administration, will be given to participants, along with printed literature reviewing key training information.

Experimental: OD training + mobile PI intervention
Participants will complete the same baseline assessment and OD training (plus naloxone) as those in the first condition. Participants also will receive mobile phones pre-loaded with the PI App and will be sent daily prompts. As part of the PI App, participants will be asked to share information about avoiding problems associated with opioid use with peers in their social network, and to encourage their peers to download the PI App for their own use.
Behavioral: OD prevention/response training + PI mobile application
Participants will receive the same OD intervention as those in the first arm, as well as receiving mobile phones pre-loaded with the PI App. This intervention includes daily prompts plus key components of evidence-based cognitive behavioral interventions, including Functional Analysis of Drug Use, Self-Management, and Social/Recreational Counseling and additional content on Distress Tolerance, the relationship between Peer Networks and Drug Use, and pertinent resources.




Primary Outcome Measures :
  1. Change in opioid use [ Time Frame: Change from baseline to 12 weeks ]
    Participant opioid use will be assessed via self-reported Timeline Followback, urine toxicology, and hair toxicology

  2. Change in self-reported injection status via Timeline Followback [ Time Frame: Change from baseline to 12 weeks ]
    Self-reports of frequency and duration of injection drug use


Secondary Outcome Measures :
  1. Change in HIV/HCV risk behavior [ Time Frame: Change from baseline to 12 weeks ]
    self-reported HIV/HCV risk behavior (combined injection and sexual risk behavior)

  2. OD [ Time Frame: 12 weeks ]
    frequency and severity of self-reported overdose (OD) episodes

  3. Peer IDU norms [ Time Frame: Change from baseline to 12 weeks ]
    Self-reported perceptions of peer injection drug use-related norms



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 29 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Current opioid use, defined as having used heroin and/or POs 12 or more times in the past 30 days (self-report verified by urine toxicology)
  • Aged 18-29 years, verified by photo ID
  • Able to understand and speak English
  • Willing and available to participate in the assigned intervention.

Exclusion Criteria:

  • Individuals are excluded if they report regular injection drug use (defined as injection 3 or more times/week in the past 30 days) for a period of more than 24 months

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): NCT03610672


Contacts
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Contact: Michelle Acosta 2128454535 acosta@ndri.org
Contact: Honoria Guarino 2128454540 guarino@ndri.org

Locations
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United States, New York
National Development and Research Institutes, Inc. Recruiting
New York, New York, United States, 10010
Contact: Lisa Bernhard    212-845-4567    bernhard@ndri.org   
Sponsors and Collaborators
National Development and Research Institutes, Inc.
Investigators
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Principal Investigator: Michelle Acosta NIDA/NIH
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Responsible Party: National Development and Research Institutes, Inc.
ClinicalTrials.gov Identifier: NCT03610672    
Other Study ID Numbers: R34DA043957 ( U.S. NIH Grant/Contract )
First Posted: August 1, 2018    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: July 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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Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders