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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06124898
Other study ID # IRB22-11-43
Secondary ID R34AA029224-01
Status Recruiting
Phase N/A
First received
Last updated
Start date November 9, 2023
Est. completion date February 28, 2025

Study information

Verified date January 2024
Source Northeastern University
Contact Jade Martinez, BS
Phone (617)697-7169
Email ja.martinez@northeastern.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 intervention will be made up of brief telehealth counseling and psychoeducation and use of three mobile technologies to facilitate moderate drinking. In the first stage of the study, we will conduct formative research to obtain input from the study population, test initially the telehealth version of the brief counseling and psychoeducation and to develop a simple, "low tech" approach to coaching participants to use the three mobile technologies in typical drinking situations. Participation will last approximately one month.


Recruitment information / eligibility

Status Recruiting
Enrollment 115
Est. completion date February 28, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 25 Years
Eligibility Each subject must: 1. Be between the ages of 18-25 2. Be able to read English and complete study evaluations 3. 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 4. 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. 5. Meet, at minimum, DSM-5 criteria for a mild alcohol use disorder (i.e., meet at least 2 diagnostic criteria) 6. 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: 1. Have been in inpatient or intensive outpatient treatment within the past 12 months 2. Have used a smartphone application to facilitate moderate drinking more than 1 time within the past 12 months 3. 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. 4. 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. 5. Be psychotic or otherwise severely psychiatrically disabled 6. 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)

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Alcohol-related mobile health technologies
Participants will be asked to use the three mobile technologies as they choose while drinking for a two-week period.
Behavioral:
Motivational interview and psychoeducation on blood/breath alcohol concentration
Brief 25/30-minute motivational interview and psychoeducation on blood/breath alcohol concentration that includes both personalized and standardized information.
Lower tech facilitation
Study staff will review instructions for technology use closely with participants and guide them in use of existing phone technologies as reminders for use of the three moderate drinking technologies during drinking situations.
Device:
Higher tech facilitation
Participants will use an app developed during the study that will provide protective behavioral strategies and reminders for use of the three moderate drinking technologies during drinking situations.
Behavioral:
Attention control psychoeducation
Brief 25/30-minute psychoeducation on a topic not related to alcohol use that will be developed in the course of the study.
Device:
Attention control technology
App or other form of technology that will be developed in the course of the study to deliver information not related to alcohol use

Locations

Country Name City State
United States EDGE Lab Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Northeastern University National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Technology utilization Percentage of reported drinking days on which one reports that moderate drinking technology use has occurred Across the field testing period, 2-4 weeks
Primary Acceptability Score on acceptability subscale of Modified System Usability Scale At the end of the field testing period, 2-4 weeks
Primary Usability Score on acceptability subscale of Modified System Usability Scale At the end of the field testing period, 2-4 weeks
Secondary Drinks per drinking day Number of drinks per day during field testing period Across the field testing period, 2-4 weeks
Secondary Estimated blood alcohol content Average estimated blood alcohol content reached on drinking days Across the field testing period, 2-4 weeks
Secondary Negative consquences Score on the Young Adult Alcohol Consequences Questionnaire At the end of the field testing period, 2-4 weeks
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