NCT07663448

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress36%
Jun 2026Apr 2027

First Submitted

Initial submission to the registry

June 4, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

June 8, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 23, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

June 23, 2026

Status Verified

May 1, 2026

Enrollment Period

11 months

First QC Date

June 4, 2026

Last Update Submit

June 17, 2026

Conditions

Alcohol DrinkingOpioid Use

Outcome Measures

Primary Outcomes (3)

  • The number of participants who complete all weeks of the mHealth intervention.

    The number of participants who complete all weeks of the mHealth intervention.

    Through study completion, an average of 1 year

  • Client Satisfaction Questionnaire

    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)

    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

Study Arms (1)

mHealth Intervention

EXPERIMENTAL

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.

Behavioral: mHealth Intervention

Interventions

mHealth InterventionBEHAVIORAL

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.

mHealth Intervention

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Pregnant or nursing
  • Current suicidality
  • History of psychosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brown University Center for Alcohol and Addiction Studies

Providence, Rhode Island, 02912, United States

RECRUITING

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Central Study Contacts

Robert Miranda, PhD

CONTACT

401-863-6658Robert_Miranda_Jr@brown.edu

Kristin Rogers, MS

CONTACT

401-863-6463Kristin_Rogers@brown.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2026

First Posted

June 23, 2026

Study Start

June 8, 2026

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2027

Last Updated

June 23, 2026

Record last verified: 2026-05

Locations

US(1)