Mobile Intervention for Young Opioid Users

NCT03610672 | Unknown

• 1 other identifier: R34DA043957
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid-Related Disorders

Outcome Measures

Primary Outcomes (2)

• Change in opioid use

  Participant opioid use will be assessed via self-reported Timeline Followback, urine toxicology, and hair toxicology

  Change from baseline to 12 weeks

• Change in self-reported injection status via Timeline Followback

  Self-reports of frequency and duration of injection drug use

  Change from baseline to 12 weeks

Secondary Outcomes (3)

• Change in HIV/HCV risk behavior

  Change from baseline to 12 weeks

• OD

  12 weeks

• Peer IDU norms

  Change from baseline to 12 weeks

Study Arms (2)

OD prevention/response training

ACTIVE COMPARATOR

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

OD training + mobile PI intervention

EXPERIMENTAL

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

Interventions

OD prevention/response training BEHAVIORAL

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.

OD prevention/response training

OD prevention/response training + PI mobile application BEHAVIORAL

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.

OD training + mobile PI intervention

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Development and Research Institutes, Inc.: lead

Study Sites (1)

National Development and Research Institutes, Inc.

New York, New York, 10010, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Michelle Acosta

  NIDA/NIH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle Acosta

CONTACT

2128454535; acosta@ndri.org

Honoria Guarino

CONTACT

2128454540; guarino@ndri.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The current study is a two-armed, open randomized clinical trial design.

Study Record Dates

• First Submitted: July 16, 2018
• First Posted: August 1, 2018
• Study Start: September 15, 2017
• Primary Completion: November 28, 2019
• Study Completion: February 28, 2020
• Last Updated: August 2, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)