Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04656925 |
| Other study ID # |
IRB 18376 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 29, 2021 |
| Est. completion date |
December 8, 2021 |
Study information
| Verified date |
January 2022 |
| Source |
Washington State University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Alcohol abuse remains a significant cause of preventable morbidity and mortality in the US.
Yet only 15% of those with alcohol use disorders receive treatment. Contingency Management
(CM) is a cost-effective intervention for drug addiction where individuals are rewarded when
they submit biological verification of drug abstinence. The researchers propose to develop an
integrated CM system capable of incorporating mobile device input, that would allow them to
deliver a CM intervention for problematic drinking to anyone who owns a smartphone. The
mobile device input will incorporate ecological momentary assessments (EMA), geospatial
mapping, and biomarker-based feedback from a portable measuring device.
Description:
The researchers propose to develop an integrated Contingency Management (CM) system capable
of incorporating mobile device input, which would allow them to deliver a CM intervention for
problematic drinking to anyone who owns a smartphone. The location of participants through
their cell phone will be recorded. The researchers will be using this data to create a
"heat-map" to find problem areas of drinking. The application works only on iPhone 7 or a
newer version with an (iPhone Operating System) iOS 13.5. If the participant does not have an
iPhone 7 or a newer version, the researcher can loan one to the participant if he/she knows
how to use it, but it must be returned at the end of the study.
The primary aim is to combine mobile technology, geospatial mapping, and biomarker
measurement, with individual goal setting and ecological momentary assessments (EMA) feedback
to launch behavioral modification strategies and progress monitoring.
People can participate if they are 1) age 18-65 years; 2) have an Alcohol Use Disorders
Identification Test (AUDIT) score of 8 or higher; 3) have the ability to read and speak
English; 4) have the ability to provide written informed consent; 5) have a breath alcohol of
0.00 during informed consent, and 6) can operate a smartphone with an active service
provider.
The researchers will utilize an A-B-A completely within-subject design with the intent of
recruiting twenty total participants from the Community in Spokane.
During the first A phase, participants will receive reinforcement for simply submitting
breath samples 3 times per day between 4 and 6 hours apart.
During the B phase, the delivery of reinforcers will be contingent upon the submission of an
alcohol negative breath sample on an escalating schedule.
The A phase or return to the baseline phase will involve the delivery reinforcers for simply
submitting a sample during the designated windows of time.
The researchers will also collect other EMA data on stress, anxiety, depression, and other
brief measures daily through participants' smartphone. Each phase will last a total of 4
weeks (i.e., 2 weeks of the first A phase, 4 weeks of the B phase, and then 2 more weeks of
the A-phase) each for a total of 8 weeks of participation. Participants will be asked to
submit 3 breath samples per day through a Bluetooth enabled breathalyzer developed by
BACTrack no less than 8 hours apart and no more than 12 hours apart. Test results for breath
alcohol will be available instantly to the participant and uploaded to the CM response system
almost immediately.
As part of this CM system, participants will have the capability to receive multi-modal
message reminders when they enter a new window of needed biochemical sample submission and
additional reminders when the window of sample submission is about to close. While
participants will receive information messages to this effect during the A phase,
participants will receive additional personalized multi-modal message reminders once the CM
platform can detect that they have entered a cold or hot zone. For example, upon entering a
hot zone radius during the B phase wherein they had a greater 50% likelihood of drinking in
that zone during the A phase, they will receive a text message encouraging them to change
surroundings in order to better promote abstinence. Also, if the participant is within a
window of time where they are eligible to submit a sample and receive a dose of
reinforcement, this is another action that the individual can take to help bolster their
attempt to remain abstinent. All these data (i.e., biochemical results, location of sample
submission, time of submission, and other bits of data) will be collected and be presented in
summary form to the research team. This will help the team devise an action plan if the
participant's drinking behavior is proving impervious to intervention or if the participant's
goals are being met, this is something the researcher can encourage about.
