Status:
ACTIVE_NOT_RECRUITING
Multi-Component Breath Alcohol Intervention
Lead Sponsor:
Northeastern University
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcohol Use
Alcohol Drinking
Eligibility:
All Genders
18-25 years
Phase:
NA
Brief Summary
This is the first stage of a three-stage, NIH-funded study to develop and test initially a multi-modal intervention concerning blood/breath alcohol concentration for young adults. The multimodal inter...
Eligibility Criteria
Inclusion
- Each subject must:
- Be between the ages of 18-25
- Be able to read English and complete study evaluations
- Report at least four days with heavy episodic drinking (i.e., 4 or more drinks for women and 5 or more drinks for men) out of the prior 30 days
- Report having consumed at least one alcoholic drink during a minimum of 12 days out of the prior 30 so that subjects will have multiple opportunities to use the moderate drinking technologies during the intervention period.
- Meet, at minimum, DSM-5 criteria for a mild alcohol use disorder (i.e., meet at least 2 diagnostic criteria)
- Self-report interest in using a smartphone app to help reduce drinking with a score of at least 3 on a 0-10 scale indicating at least a degree of openness to using technology to moderate drinking.
- Exclusion Criteria
- No subject may:
- Have been in inpatient or intensive outpatient treatment within the past 12 months
- Have used a smartphone application to facilitate moderate drinking more than 1 time within the past 12 months
- Meet DSM-5 criteria for current substance use disorder with the exception of tobacco use disorder, mild or moderate alcohol use disorder or mild cannabis use disorder.
- History of alcohol withdrawal or medically-assisted detoxification as individuals with this history will likely be in need of more intensive treatment than is offered in this study.
- Be psychotic or otherwise severely psychiatrically disabled
- Report a history of a medical condition that would contraindicate the consumption of alcohol (e.g., liver disease, cardiac abnormality, pancreatitis, diabetes, neurological problems, and gastrointestinal disorders)
Exclusion
Key Trial Info
Start Date :
November 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT06124898
Start Date
November 9 2023
End Date
September 1 2025
Last Update
May 22 2025
Active Locations (1)
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1
EDGE Lab
Boston, Massachusetts, United States, 02115