Targeting alcohol-opioid co-use among young adults with a new mobile health tool

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project develops and pilots an adaptive mHealth intervention designed for 18- to 25-year-olds who use alcohol and opioids together. The study uses ecological momentary assessment to understand real-time patterns of co-use and to inform the app's features. The goal is to create a practical tool that can reach young adults not currently in treatment and support reductions in co-use and related harms. The intervention is led by Brown University with collaboration from NIAAA and will be implemented at Brown University’s Center for Alcohol and Addiction Studies in Providence, RI. No phase is specified, and the work emphasizes development and pilot testing of the technology and user experience.

Why it matters

Who can join: the full rules

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

Where it's running

• Brown University Center for Alcohol and Addiction Studies
  Providence, Rhode Island, United States Recruiting

Study contacts

• Study coordinator: Robert Miranda, PhD
• Email: Robert_Miranda_Jr@brown.edu
• Phone: 401-863-6658

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.