An interventional study of mHealth Intervention in Alcohol Drinking and Opioid Use, sponsored by Brown University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-23.
Sponsored by Brown University · Not applicable, Interventional, and Treatment
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.
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.
701 studies on the registry are indexed under Alcohol Drinking; 133 are open to participants now.
This study's planned enrollment of 30 is below the median of 122 across 607 interventional studies indexed under Alcohol Drinking.
Browse Alcohol Drinking studies →Brown University is the lead sponsor of 290 studies on the registry; 40 are open to participants now.
Of its 26 completed or terminated interventional studies of FDA-regulated products, 19 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
The number of participants who complete all weeks of the mHealth intervention.
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
Acceptability and satisfaction of treatment. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.
Time frame: 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.
Time frame: Through study completion, an average of 1 year
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Started Jun 2026 (actual). Primary completion is estimated for Apr 2027, 10 months after the start.
Of 328 non-industry interventional studies with no phase under Alcohol Drinking, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's planned 10 months is below that.
Counting every sponsor, half of 336 studies reached it within 24 months; a quarter within 10 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
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