Clinical trial NCT06124898: Multi-Component Breath Alcohol Intervention
Official title: Development and Initial Testing of a Multi-Component Breath Alcohol- Focused Intervention for Young Adults
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Alcohol Use
Alcohol Drinking
Drinking Behavior
Lead sponsor: Northeastern University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2023-11-09
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Technology utilization
timeFrame: Across the field testing period, 2-4 weeks
measure: Acceptability
timeFrame: At the end of the field testing period, 2-4 weeks
measure: Usability
timeFrame: At the end of the field testing period, 2-4 weeks
Secondary outcomes:
measure: Drinks per drinking day
timeFrame: Across the field testing period, 2-4 weeks
measure: Estimated blood alcohol content
timeFrame: Across the field testing period, 2-4 weeks
measure: Negative consquences
timeFrame: At the end of the field testing period, 2-4 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: EDGE Lab
state: Massachusetts
Study officials:
affiliation: Northeastern University
name: Robert F Leeman, PhD.
role: PRINCIPAL_INVESTIGATOR
References: