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Biosensor Feedback Intervention for Alcohol Abuse
N/A
Waitlist Available
Led By Lisa Fucito, PhD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18-25 years of age
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 weeks
Awards & highlights
Study Summary
This trial will test whether an intervention delivered through biosensors and an electronic diary can help reduce heavy drinking and improve health in young adults.
Who is the study for?
This trial is for young adults aged 18-25 who drink heavily, as indicated by specific scores on a drinking risk test (AUDIT-C), and have had at least four heavy drinking episodes in the past month. They must speak English and own a smartphone. People with recent or current treatment for alcohol/sleep issues, drug use (except marijuana), severe alcohol use disorder, sleep disorders, psychiatric illness, or substance abuse can't join.Check my eligibility
What is being tested?
The study is testing a new way to help young adults drink less using technology. It involves monitoring heart rate variability, resting heart rate, and sleep patterns through biosensors and electronic diaries to provide feedback aimed at reducing alcohol consumption.See study design
What are the potential side effects?
Since this intervention is behavioral involving self-management techniques and feedback from sensors rather than medication or medical procedures, it may not have typical side effects but could include increased awareness of personal health behaviors which might lead to stress or anxiety.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 25 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Total drinks consumed
Secondary outcome measures
Alcohol-related consequences
Drinks per drinking day
Heart Rate Variability (HRV)
+6 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: Self-Monitoring and FeedbackActive Control1 Intervention
The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep behaviors daily during this time. On weeks two, four, and six subjects will receive personalized health feedback based on the PPG device data and sleep diaries.
Group II: Self-MonitoringPlacebo Group1 Intervention
The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep behaviors daily during this time.
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Who is running the clinical trial?
Yale UniversityLead Sponsor
1,848 Previous Clinical Trials
2,737,758 Total Patients Enrolled
6 Trials studying Alcohol Abuse
1,161 Patients Enrolled for Alcohol Abuse
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
800 Previous Clinical Trials
1,362,937 Total Patients Enrolled
81 Trials studying Alcohol Abuse
28,511 Patients Enrolled for Alcohol Abuse
Lisa Fucito, PhDPrincipal InvestigatorAssociate Professor of Psychiatry; Director, Tobacco Treatment Service, Psychiatry
4 Previous Clinical Trials
341 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 25 years old.I have a history of sleep disorders.
Research Study Groups:
This trial has the following groups:- Group 1: Self-Monitoring and Feedback
- Group 2: Self-Monitoring
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research encompassing elderly participants aged 85 and over?
"This trial only allows people between 18 and 25 to apply. However, there are separate medical studies available for younger individuals as well as seniors aged 65+."
Answered by AI
How many participants are being accepted for this medical experiment?
"Indeed, clinicaltrials.gov's data suggests that this medical experiment is presently recruiting participants - it was first posted on February 23rd 2022 and most recently edited on April 25th 2022. The research team seeks to have 60 individuals enrolled at 1 site."
Answered by AI
How can I access this experimental treatment?
"To qualify for this clinical study, applicants must be between 18 and 25 years old and have a history of excessive alcohol consumption. There are 60 total places available in the trial."
Answered by AI
Is entry into this experiment being offered to participants at the present time?
"Affirmative. The details hosted on clinicaltrials.gov indicate that this medical investigation, made public on February 23rd 2022 is still recruiting volunteers. A total of 60 people should be registered at one location for the trial to move forward."
Answered by AI
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