Purpose

This is the third stage of a three-stage, NIH-funded study to develop and test a multi-modal intervention concerning blood/breath alcohol concentration for young adults who drink heavily. The multimodal intervention will be made up of brief telehealth counseling and psychoeducation and use of three existing mobile technologies. The brief counseling/psychoeducation and mobile technologies provide personalized feedback regarding blood or breath alcohol content. The long-term goal of use of these mobile technologies will be to facilitate moderate drinking. However, the main goals of the proposed research are to learn more about feasibility of our procedures, perceived value of the technologies and ease of use from the research participants' points of view. In this third stage of the study, the investigators will conduct a randomized controlled trial building on the formative research conducted in Stages 1 and 2.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 25 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Criteria

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Moderate drinking technologies with "lower tech" facilitation
Brief motivational-interviewing-based counseling followed by use of three moderate drinking technologies (breath alcohol device and app, blood alcohol content estimator app and self-texting procedure) with "lower tech" facilitation.
  • Device: Alcohol-related mobile health technologies
    Participants will be asked to use the mobile technologies as they choose while drinking for a four-week period.
    Other names:
    • Smartphone Breathalyzer
    • BAC Estimator App
    • Self-Texting App
  • 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.
    Other names:
    • M.I.
  • Behavioral: 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.
Experimental
Moderate drinking technologies with "higher tech" facilitation
Brief motivational-interviewing-based counseling followed by use of three moderate drinking technologies (breath alcohol device and app, blood alcohol content estimator app and self-texting procedure) with "higher tech" facilitation
  • Device: Alcohol-related mobile health technologies
    Participants will be asked to use the mobile technologies as they choose while drinking for a four-week period.
    Other names:
    • Smartphone Breathalyzer
    • BAC Estimator App
    • Self-Texting App
  • 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.
    Other names:
    • M.I.
  • Behavioral: Higher tech facilitation
    Participants will use an app developed during the study, SmartSip, that will provide protective behavioral strategies and reminders for use of the three moderate drinking technologies during drinking situations.
    Other names:
    • SmartSip
Active Comparator
Alcohol Education Condition
Brief session administering non-personalized information about alcohol followed by the option to receive educational alcohol-related information via text
  • Behavioral: Alcohol Education
    Brief 25/30-minute psychoeducation on generalized alcohol use providing information about alcohol and its effects, adapted from the National Institute on Alcohol Abuse and Alcoholism (NIAAA) Rethinking Drinking resources
  • Device: Alcohol Education Technology
    Participants will be able to prompt text messages which will provide them one-off trivia facts using information provided during the attention control psychoeducation session

Recruiting Locations

Northeastern University
Boston, Massachusetts 02115-5005
Contact:
Jade Martinez, B.S.
617-697-7169
ja.martinez@northeastern.edu

More Details

Status
Recruiting
Sponsor
Northeastern University

Study Contact

Jade Martinez, B.S.
(617) 373-5132
ja.martinez@northeastern.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.