Breath Alcohol Intervention for Alcohol Use Disorder

(BAMTECH Trial)

Overseen By Allie Farone, M.S.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Northeastern University

Disqualifiers: Severe substance use disorder, psychotic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new approach to help young adults who drink heavily manage their alcohol intake. Participants will use mobile technologies, such as a breath alcohol device and apps, to receive personalized feedback on their drinking habits. The study compares different methods of using these tools, focusing on their ease of use and value for participants. It seeks young adults who frequently consume several drinks at a time and drink on at least 12 days a month. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could lead to new strategies for managing alcohol consumption.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this multi-component breath alcohol intervention is safe?

Research has shown that the multi-part breath alcohol program helps people reduce their drinking. It employs mobile apps and short counseling sessions to give feedback on blood or breath alcohol levels. While specific safety data from earlier stages is unavailable, monitoring alcohol levels with mobile apps and devices is generally safe.

As this trial is in its final stage and does not involve new drugs or invasive procedures, the program is likely manageable. It relies on existing technology and counseling to support moderate drinking, indicating a low risk of side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to manage alcohol use disorder by using technology to encourage moderate drinking. Unlike traditional treatments like counseling or medication, this approach combines motivational interviewing with cutting-edge tools, such as a breath alcohol device, a blood alcohol content estimator app, and a self-texting procedure. The trial tests two versions of this tech-assisted intervention: one with "higher tech" facilitation and another with "lower tech" facilitation, offering a unique blend of personal support and technology use. This could lead to more personalized and accessible treatment options, making it easier for individuals to manage their alcohol consumption effectively.

What evidence suggests that this trial's multi-component breath alcohol intervention could be effective for alcohol use disorder?

This trial will evaluate a multi-component breath alcohol intervention to help manage alcohol use. Participants will be assigned to different arms: one arm will use moderate drinking technologies with "higher tech" facilitation, another with "lower tech" facilitation, and a third will receive an alcohol education condition. Studies have shown that such multi-part programs, which include short counseling sessions via phone or video and use mobile technology to provide personalized feedback on drinking habits, can lower blood alcohol levels over time. Research indicates that these tools are more effective at reducing heavy drinking than standard methods. This combined approach shows promise for adults who have difficulty with alcohol use. The goal is to encourage healthier drinking habits. ^{1 2 6 7 8}

Who Is on the Research Team?

Robert F Leeman, Ph.D.

Principal Investigator

Northeastern University

Are You a Good Fit for This Trial?

This trial is for young adults who drink heavily and are interested in moderating their alcohol consumption. Participants should be willing to engage with telehealth counseling, psychoeducation, and use mobile technologies that provide feedback on their alcohol levels.

Inclusion Criteria

Be able to read English and complete study evaluations

At least occasional heavy episodic drinking (i.e., 4 or more drinks for women and 5 or more drinks for men) over the prior 30 days

Frequent consumption of 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.

Exclusion Criteria

Be psychotic or otherwise severely psychiatrically disabled

Severe substance use disorder

I have a health condition that prevents me from drinking alcohol.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive brief telehealth counseling and psychoeducation, and use three mobile technologies for personalized feedback on blood or breath alcohol content

4 weeks

Telehealth sessions and mobile app usage

Follow-up

Participants are monitored for feasibility, perceived value, and ease of use of the technologies

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Multi-Component Breath Alcohol Intervention

Trial Overview

The study tests a multi-modal intervention combining brief telehealth counseling/psychoeducation with three mobile technologies aimed at providing personalized feedback on blood or breath alcohol content to promote moderate drinking habits.

How Is the Trial Designed?

Group I: Moderate drinking technologies with "lower tech" facilitation Experimental Treatment 3 Interventions

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.

Group II: Moderate drinking technologies with "higher tech" facilitation Experimental Treatment 3 Interventions

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

Group III: Alcohol Education Condition Active Control 2 Interventions

Brief session administering non-personalized information about alcohol followed by the option to receive educational alcohol-related information via text

Who Is Running the Clinical Trial?

Northeastern University

Lead Sponsor

Trials

103

Recruited

72,600+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06994962

Multi-Component Breath Alcohol Intervention Phase 3 | ...

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 ...

2.

trialx.com

trialx.com/clinical-trials/listings/306411/multi-component-breath-alcohol-intervention-phase-3/

Multi-Component Breath Alcohol Intervention Phase 3

The multimodal intervention will be made up of brief telehealth counseling and psychoeducation and use of three existing mobile technologies.

3.

withpower.com

withpower.com/trial/phase-1-alcohol-drinking-9-2023-ef5a1

Multi-Component Intervention for Alcohol Use Disorder ...

Studies indicate that these interventions can lead to significant reductions in blood alcohol concentration over time, suggesting they are effective in ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S0376871624003296

Integrated behavioral interventions for adults with alcohol ...

Studies revealed that integrated intervention led to significant reductions in heavy drinking compared to usual care or other interventions. •.

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10882804/

Predictors of treatment outcome for individuals with alcohol ...

A total of 57% of individuals in BSCT attained a level of CD, as opposed to 43% in MET. Females were significantly better in attaining low-risk ...

6.

trialx.com

trialx.com/clinical-trials/listings/280544/multi-component-breath-alcohol-intervention/

Multi-Component Breath Alcohol Intervention

This is the first stage of a three-stage, NIH-funded study to develop and test initially a multi-modal intervention concerning blood/breath ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12238138/

Investigating Therapeutic Targets for Alcohol Use Disorder

This study aims to explore therapeutic targets in AUD by analyzing interventional clinical trials registered on ClinicalTrials.gov. It seeks to ...

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S2772598724000291

Digital interventions for alcohol use disorders: A narrative ...

This narrative review aimed to summarize recent evidence on the use of digital interventions for AUD, and to critically assess the promise and pitfalls of ...