Targeting Alcohol-Opioid Co-Use Among Young Adults Using a Novel MHealth Intervention
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-25
SponsorBrown University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Pregnant or nursing
Current suicidality
History of psychosis
Trial design
Design model
Single group
Treatments tested in this trial
mHealth Intervention
BehavioralMobile 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: mHealth InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 year2
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 year3
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 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Brown University
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Source ClinicalTrials.gov