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Opioid-Related DisordersNCT03610672

Mobile Intervention for Young Opioid Users

A study testing OD prevention/response training and OD prevention/response training + PI mobile application in people with Opioid-Related Disorders, run by National Development and Research Institutes, Inc. at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 29 yearsHealthy volunteers can take part
Conditions the study is for
Opioid-Related Disorders
What is being tested?
OD prevention/response training and OD prevention/response training + PI mobile application
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteUnited States
Study dates
15 Sep 2017to 28 Feb 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 29 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Michelle Acosta contact

2128454535

acosta@ndri.org

Honoria Guarino contact

2128454540

guarino@ndri.org

United States1 site, 1 recruiting
  • National Development and Research Institutes, Inc.

    New York, New York, 10010

    Lisa Bernhard, 212-845-4567, bernhard@ndri.org

    Recruiting

Other trials in United States

About this study

Official title: Preventing Injection: An mHealth Intervention That Leverages Social Networks to Prevent Progression to Injection Among Young Opioid Users

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.

Read the detailed description

Opioid use disorders (OUD) are the second most common type of drug use disorder in the US, with nearly 2 million reporting prescription opioid (PO) use and ~570,000 reporting heroin use consistent with an OUD. Further, drug overdose (OD) has become the leading cause of accidental death in the US, with opioid-involved OD driving this epidemic. The recent escalation in OUD has been most pronounced among youth, with nearly 1/3 of youth reporting PO misuse by age 21, and studies have documented the trajectory from PO misuse to injection drug use (IDU) in youth. An ongoing study conducted by the current investigators documented an alarming trajectory, wherein these youth progress from nonmedical PO use in adolescence (first PO use M=16.7 y/o), to oral / intranasal heroin use in young adulthood (M=19.1 y/o), with 64% progressing to injection drug use (IDU), within a year of heroin initiation (first injection M=20.1 y/o. This progression to IDU is characterized by uniquely high levels of risk for youth, including higher rates of injection risk behaviors and OD, and higher incidence of HIV and HCV within the first few years of transitioning to injection, compared to older peers. Thus, young opioid users are at uniquely high risk for a number of negative outcomes during the critical period of transitioning to injection. This rapid progression from PO use to IDU and the extreme risk associated with new injection status among youth indicate that there is a brief, but critical, period during which we may intervene to prevent progression to injection and its associated risk behaviors and negative health outcomes. Several robust predictors have been found for progression to IDU, including psychosocial factors (i.e., homelessness, physical abuse), OUD severity (i.e., dependence severity, polydrug use), and IDU norms and behaviors within one's social network. While there is some understanding of the mechanisms that promote IDU, there is virtually no research on strategies to prevent this transition. Only one intervention has been examined targeting intranasal heroin users in an attempt to prevent progression to IDU. This "sniffers" intervention found potent effects; half as many intervention participants progressed to injection (33% vs. 16%), compared to the control condition (who received HIV/AIDS education), indicating that direct intervention with opioid users may be an effective way to prevent progression to IDU and its associated harms. It is unclear why so few interventions have targeted this population, although young opioid users face a number of unique barriers, including social, economic, and motivational, that may prevent them from seeking and receiving treatment. Given the paucity of interventions available to the large and vulnerable group of opioid-using young adults, there is an urgent need to develop and evaluate innovative, engaging approaches to prevent young opioid users from transitioning to IDU.

The current application is being submitted in response to PA 16-073, "Behavioral and Integrative Treatment Development Program." The proposed project is a Stage Ib study that will adapt a mobile, evidence-based psychosocial intervention for opioid dependence (Check-In App) to prevent progression to injection in young opioid users (18-29 y/o) who have not progressed to regular injection.

Aim 1: During months 1-12, we will adapt the Check-In App to target reducing opioid use and preventing progression to injection among young oral / intranasal opioid users. We will tailor our existing mHealth intervention (including daily text messages plus key components of evidence-based cognitive behavioral interventions, Functional Analysis of Drug Use, Self-Management, and Social / Recreational Counseling), for young opioid users. New components specific to youth will focus on the role of peers in opioid use / IDU, and OD prevention / response training including use of naloxone. 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 newly tailored mHealth intervention with young opioid users (18-29 y/o) 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 the Preventing Injection Application. We will evaluate the intervention's feasibility, acceptability, diffusion, and preliminary effectiveness. Feasibility and acceptability will be assessed via participant feedback, retention, and app 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 and 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 episodes, opioid-related problems (e.g., withdrawal episodes), and social network IDU-related norms and behaviors.

If results are promising, this intervention will be evaluated in a large-scale efficacy / effectiveness trial. This intervention may have tremendous impact on improving access, acceptability, and potency of opioid use interventions for youth, given the extremely widespread use of mobile apps among young adults (98% of 18-29 y/o own mobile phones and spend ~3 hr/day using mobile apps).

Being tested
OD prevention/response training, OD prevention/response training + PI mobile application
Medical subject headings
Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OD prevention/response trainingBehavioural

    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 + PI mobile applicationBehavioural

    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.

Study groups in NCT03610672
Study groupRoleWhat they receive
OD prevention/response trainingActive comparatorImmediately 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.
Receives: Behavioral: OD prevention/response training
OD training + mobile PI interventionExperimentalParticipants 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.
Receives: Behavioral: OD prevention/response training + PI mobile application

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in opioid use

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

    Measured: Change from baseline to 12 weeks

  2. Change in self-reported injection status via Timeline Followback

    Self-reports of frequency and duration of injection drug use

    Measured: Change from baseline to 12 weeks

Secondary outcomes (3)
  1. Change in HIV/HCV risk behavior

    self-reported HIV/HCV risk behavior (combined injection and sexual risk behavior)

    Measured: Change from baseline to 12 weeks

  2. OD

    frequency and severity of self-reported overdose (OD) episodes

    Measured: 12 weeks

  3. Peer IDU norms

    Self-reported perceptions of peer injection drug use-related norms

    Measured: Change from baseline to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2018
  2. Study start15 Sep 2017
  3. Primary completion28 Nov 2019 (estimated)
  4. Study completion28 Feb 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Model description
The current study is a two-armed, open randomized clinical trial design.
Masking
None (open label)
Enrolment
64 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03610672
Sponsor's protocol ID
R34DA043957
Status last verified
Jul 2018
First submitted
16 Jul 2018
Last updated
2 Aug 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing OD prevention/response training and OD prevention/response training + PI mobile application in people with Opioid-Related Disorders, run by National Development and Research Institutes, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Michelle Acosta (2128454535, acosta@ndri.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in opioid use (time frame: Change from baseline to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2018.

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