Multi-Component Breath Alcohol Intervention Phase 3
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
- Alcohol Use
- Alcohol Drinking
- Drinking Behavior
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
| Arm | Description | Assigned 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. |
|
|
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 |
|
|
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 |
|
Recruiting Locations
Boston, Massachusetts 02115-5005
More Details
- Status
- Recruiting
- Sponsor
- Northeastern University