- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07663448
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
Betingelser
Intervention / Behandling
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
- Navn: Robert Miranda, PhD
- Telefonnummer: 401-863-6658
- E-mail: Robert_Miranda_Jr@brown.edu
Undersøgelse Kontakt Backup
- Navn: Kristin Rogers, MS
- Telefonnummer: 401-863-6463
- E-mail: Kristin_Rogers@brown.edu
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:
- Ages 18 to 25 years, inclusive
- 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).
- 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.
- Able to understand written and oral instructions in English, communicate understanding of the consent form, and provide written informed consent.
- Complete all assessments required at screening.
- 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.
- Own a smartphone with data plan. Almost all participants (98%) in our preliminary work owned a smartphone with data plan.
- Currently reside in the United States of America.
Exclusion Criteria:
- Pregnant or nursing
- Current suicidality
- 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.
Sponsor
Samarbejdspartnere
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
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Alkohol drikke
-
University of California, San FranciscoNational Institute on Drug Abuse (NIDA)Afsluttet
-
New York UniversityNational Institute on Alcohol Abuse and Alcoholism (NIAAA)RekrutteringHeavy Episodic DrinkingForenede Stater
-
Florida International UniversityNational Institute on Alcohol Abuse and Alcoholism (NIAAA); UConn HealthRekrutteringUnge voksne | Heavy Episodic Drinking | MBSRForenede Stater
-
University of North Carolina, Chapel HillNational Institute on Alcohol Abuse and Alcoholism (NIAAA)RekrutteringHIV-forebyggelse | Alkoholforbrug | PrEP optagelse | HIV behandling | Seneste Heavy DrinkingMalawi
-
Arizona State UniversityUniversity of Iowa; University of New MexicoAfsluttetRisikofyldt seksuel adfærd | Heavy Episodic Drinking | Seksuelt aggressiv adfærdForenede Stater
-
University Medicine GreifswaldGerman Federal Ministry of Education and ResearchAfsluttetAlkohol afhængighed | Alkohol misbrug | Risiko-drikning | Heavy Episodic Drinking
Kliniske forsøg med mHealth Intervention
-
The Hong Kong Polytechnic UniversityThe University of Hong Kong; Kwong Wah Hospital; University of Glasgow; Tsan...RekrutteringLivskvalitet | Familieforhold | Postnatal depressionHong Kong
-
University of CadizAndalusian Health ServiceRekruttering
-
Children's National Research InstituteRekrutteringSeksuelt overførte sygdommeForenede Stater
-
Ohio State University Comprehensive Cancer CenterNational Cancer Institute (NCI); Ohio UniversitySuspenderetMelanom | Brystkræft | Myelomatose | Lungekræft | ProstatakræftForenede Stater
-
Kaiser PermanenteAfsluttetRygning | RygestopForenede Stater
-
KU LeuvenJomo Kenyatta University of Agriculture and TechnologyAfsluttet
-
University of FloridaAfsluttet
-
Fundació Institut de Recerca de l'Hospital de la...Afsluttet
-
New York State Psychiatric InstituteNational Institute of Mental Health (NIMH); Northwell Health, Early Treatment... og andre samarbejdspartnereAfsluttetSkizofreni | Psykose i første afsnitForenede Stater
-
University of OklahomaAfsluttetBørnemishandling | Forældreskab | Børns udvikling | Forsømmelse af børnForenede Stater