Recruiting

mHealth Intervention

Sponsor:

Brown University

Code:

NCT07663448

Conditions

Alcohol Drinking

Opioid Use

Eligibility Criteria

Sex: All

Age: 18 - 25

Healthy Volunteers: Accepted

Interventions

mHealth Intervention

Study Details

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.

Conditions

Alcohol Drinking

Opioid Use

Study ID

NCT07663448

Start date

Jun 8, 2026

Status verified date

May, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 25

Healthy Volunteers: Accepted

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

mHealth Intervention

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.

Primary outcome measure

  • The number of participants who complete all weeks of the mHealth intervention. [ Time Frame: Through study completion, an average of 1 year ]
  • Client Satisfaction Questionnaire [ Time Frame: Through study completion, an average of 1 year ]
  • System Usability Scale (SUS) [ Time Frame: Through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

Locations

Brown University Center for Alcohol and Addiction Studies

Recruiting

Providence, Rhode Island, United States, 02912

More Information

Sponsor

Brown University

Last update posted

Jun 23, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brown University on 2026-06-23.