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

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.

Study Overview

• Status: Recruiting
• Conditions: Alcohol Drinking; Opioid Use
• Intervention / Treatment: Behavioral: mHealth Intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Robert Miranda, PhD; Phone Number: 401-863-6658; Email: Robert_Miranda_Jr@brown.edu
• Study Contact Backup: Name: Kristin Rogers, MS; Phone Number: 401-863-6463; Email: Kristin_Rogers@brown.edu

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02912
      • Recruiting
      • Brown University Center for Alcohol and Addiction Studies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Brown University
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: June 4, 2026
• First Submitted That Met QC Criteria: June 17, 2026
• First Posted (Actual): June 23, 2026

Study Record Updates

• Last Update Posted (Actual): June 23, 2026
• Last Update Submitted That Met QC Criteria: June 17, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Drinking Behavior; Behavior; Alcohol Drinking
• Other Study ID Numbers: 2023003557

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No