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Targeting Alcohol-Opioid Co-Use Among Young Adults Using a Novel MHealth Intervention

17. juni 2026 opdateret af: Brown University
The goal of this treatment development project is to develop and pilot an adaptive mobile health (mHealth) intervention that targets the co-use of alcohol and opioids in young adults.

Studieoversigt

Status

Rekruttering

Detaljeret beskrivelse

The goal of this treatment development project is to develop and pilot an adaptive mobile health (mHealth) intervention that targets the co-use of alcohol and opioids in young adults. Alcohol is an under-recognized contributor to the opioid crisis that, when used with opioids, substantially increases the risk of opioid overdose and other use-related problems. Despite clear public health significance, however, no existing intervention targets alcohol-opioid co-use. This gap is especially detrimental to young adults aged 18-25, who have the highest rates of alcohol and opioid (i.e., nonmedical prescription opioid or heroin) use and use disorders of any age group. Over half of young adults who use nonprescription opioids report past-year alcohol-opioid co-use, yet few young adults receive treatment for either substance. MHealth interventions, which use technology (e.g., smartphone applications) to intervene in daily life, are highly accessible and acceptable to young adults. MHealth thus offers a means of targeting alcohol-opioid co-use that can reach young adults not currently in treatment. However, developing an effective mHealth intervention requires an ecologically valid understanding of the target behavior, which does not exist for alcohol-opioid co-use. Thus, the first step of the proposed project is to use ecological momentary assessment (EMA), wherein 60 young adults (ages 18-25) with mild to moderate OUD who report regular alcohol-opioid co-use will complete EMA multiple times daily via smartphone for 3 weeks to examine how, why, and when young adults co-use alcohol and opioids in real-time in their daily lives. Using established guidelines for developing mHealth interventions, the investigators will then use this EMA knowledge base to develop a smartphone-based mHealth platform targeting alcohol-opioid co-use. The intervention will be founded on principles of motivational enhancement therapy and cognitive behavioral therapy and deliver tailored micro-interventions based on participants' responses to EMA assessments. The investigators will refine the intervention based on feedback from two iterative usability studies with 10 participants. Finally, in a new sample of 60 young adults, participants will use the intervention for 28-days. The investigators will evaluate the intervention's feasibility, acceptability, and putative mechanisms of action. This study will address national priorities to respond to the accelerating opioid crisis. It will provide vital new information on the nature of alcohol-opioid co-use in daily life and develop and pilot an innovative adaptive mHealth intervention to address this behavior in young adults.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

    • Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02912
        • Rekruttering
        • Brown University Center for Alcohol and Addiction Studies

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

  1. Ages 18 to 25 years, inclusive
  2. Self-report interest in reducing their alcohol-opioid co-use - outside a research study, people who do not wish to change their co-use are unlikely to download and use an mHealth app designed to reduce co-use. It is important to recruit participants who most closely resemble the intended users of the eventual mHealth intervention. This is defined as reporting any alcohol-opioid co-use goal (i.e., not selecting "No goal" in response to the alcohol-opioid co-use goal question at the screening visit).
  3. Self-report engaging in simultaneous alcohol-opioid co-use (i.e., use of both substances within two hours) ≥ 1 day/week on average in the past 28 days (i.e., at least 4 co-use events in the past 28 days). This requirement will ensure that we observe sufficient use episodes where the pharmacological effects of alcohol and opioids overlap to evaluate project aims.
  4. Able to understand written and oral instructions in English, communicate understanding of the consent form, and provide written informed consent.
  5. Complete all assessments required at screening.
  6. Agree to the schedule of visits, verbally acknowledge that he/she/they will be able to attend each scheduled visit, participate in phone visits and that he/she/they does not have any already scheduled events or a job that may substantially interfere with study participation.
  7. Own a smartphone with data plan. Almost all participants (98%) in our preliminary work owned a smartphone with data plan.
  8. Currently reside in the United States of America.

Exclusion Criteria:

  1. Pregnant or nursing
  2. Current suicidality
  3. History of psychosis

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: mHealth Intervention
Participants in the mHealth intervention condition will use the MHealth intervention app over the trial, completing EMA prompts, receiving micro-interventions, and accessing the information stored in the app.
Mobile health intervention, delivered via smartphone, in which the person using the intervention receives timely micro-interventions based on their responses to ecological momentary assessments that they complete.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The number of participants who complete all weeks of the mHealth intervention.
Tidsramme: Through study completion, an average of 1 year
The number of participants who complete all weeks of the mHealth intervention.
Through study completion, an average of 1 year
Client Satisfaction Questionnaire
Tidsramme: Through study completion, an average of 1 year
Acceptability and satisfaction of treatment. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.
Through study completion, an average of 1 year
System Usability Scale (SUS)
Tidsramme: Through study completion, an average of 1 year
Usability of the mHealth intervention app and app satisfaction. The SUS scoring ranges from 0-100 with higher scores indicating greater perceived usability.
Through study completion, an average of 1 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

8. juni 2026

Primær færdiggørelse (Anslået)

30. april 2027

Studieafslutning (Anslået)

30. april 2027

Datoer for studieregistrering

Først indsendt

4. juni 2026

Først indsendt, der opfyldte QC-kriterier

17. juni 2026

Først opslået (Faktiske)

23. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. juni 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2023003557

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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