Multi-Component Intervention for Alcohol Use Disorder

(BAMTECH Trial)

Overseen By Allie Farone, MS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Northeastern University

Disqualifiers: Substance use disorder, Psychotic, Liver disease, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test new methods to help young adults manage alcohol consumption through telehealth counseling and mobile technology. Participants will receive guidance via either a simpler or more advanced tech setup, using apps and devices to track and moderate drinking. The goal is to evaluate the effectiveness of these tools in real-life situations. Ideal participants are young adults who have recently experienced frequent heavy drinking days and are open to using smartphone apps to help reduce their drinking. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new ways of managing alcohol consumption.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does exclude participants with certain medical conditions that contraindicate alcohol consumption.

What prior data suggests that this multi-component intervention is safe for young adults?

Research has shown that treatments involving multiple steps to reduce breath alcohol are generally easy for people to handle. Other studies have found that these treatments can lower blood alcohol levels over time, suggesting they work well. One study found that people managed the treatment comfortably. While minor side effects might occur, they are usually easy to deal with. Participants in similar studies have not reported any serious issues, indicating that the treatment is relatively safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it introduces a novel approach to managing Alcohol Use Disorder by combining technology with counseling. Unlike traditional treatments like medication or standard behavioral therapy, this trial tests the use of moderate drinking technologies, such as a breath alcohol device and app, a blood alcohol content estimator app, and a self-texting procedure. These tools are paired with either "lower tech" or "higher tech" facilitation, offering a personalized and interactive way to monitor and potentially modify drinking behaviors. This tech-enabled method could provide a more engaging and immediate way for individuals to manage their alcohol consumption, which is a fresh departure from conventional methods.

What evidence suggests that this trial's treatments could be effective for alcohol use disorder?

Research has shown that programs like the Multi-Component Breath Alcohol Intervention, which participants in this trial may receive, can help reduce heavy drinking. This trial will test two different facilitation methods for using moderate drinking technologies. One group will use a breath alcohol device, an app to estimate blood alcohol levels, and a self-texting system with "lower tech" facilitation, while another group will use these tools with "higher tech" facilitation. Studies have found that telehealth services in these programs effectively manage alcohol use. Early results suggest that motivational interviewing, a counseling method used here, helps people change their drinking habits. Overall, combining these elements has been shown to reduce alcohol consumption. ^{1 2 3 6 7}

Who Is on the Research Team?

Robert F Leeman, PhD.

Principal Investigator

Northeastern University

Are You a Good Fit for This Trial?

This trial is for young adults who regularly drink alcohol, can read English, and complete study evaluations. It's not specified who cannot join the trial.

Inclusion Criteria

You can read and understand English well enough to answer questions about the study.

You drink alcohol often.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Formative Research and Initial Testing

Conduct formative research to obtain input from the study population and test the telehealth version of the brief counseling and psychoeducation

2-4 weeks

Telehealth sessions

Field Testing

Participants use moderate drinking technologies with either 'lower tech' or 'higher tech' facilitation

2-4 weeks

Ongoing technology use

Follow-up

Participants are monitored for acceptability, technology utilization, and usability after the intervention

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Multi-Component Breath Alcohol Intervention

Trial Overview The study tests a new intervention combining telehealth counseling, psychoeducation on alcohol levels, and three mobile technologies aimed at promoting moderate drinking over about one month.

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: Attention control condition Active Control 2 Interventions

To be determined attention control condition, which will involve either non-personalized information about alcohol or feedback regarding another health behavior with minimal relationship to alcohol use, followed by related technology use.

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+

Published Research Related to This Trial

In a study involving 22,863 patients at a Veterans Affairs clinic, only 15% of those with unhealthy drinking used the electronic clinical reminder for brief intervention, indicating low engagement despite its availability.

The use of the clinical reminder did not significantly improve the resolution of unhealthy drinking among patients, suggesting that simply providing reminders is not enough and that more proactive strategies are needed to encourage brief interventions in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of an electronic clinical reminder to facilitate brief alcohol-counseling interventions in primary care. Williams, EC., Achtmeyer, CE., Kivlahan, DR., et al.[2022]

The Remote Brief Intervention and Referral to Treatment (R-BIRT) model was found to be feasible, with a 40% acceptance rate among 125 eligible emergency department patients, indicating potential for wider implementation.

Patients who received consultations during their emergency department visit had a significantly higher completion rate of 90% compared to only 10% for those contacted after their visit, suggesting that immediate intervention may enhance engagement in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The remote brief intervention and referral to treatment model: Development, functionality, acceptability, and feasibility. Boudreaux, ED., Haskins, B., Harralson, T., et al.[2018]

A systematic review of 15 studies on remote monitoring of substance use disorders (SUDs) using wearable devices found that most research focused on the intoxication stage, highlighting a gap in monitoring during withdrawal and craving phases.

Despite the potential of wearable sensors to track physiological parameters like heart rate and temperature, the current evidence is insufficient to support their use for effective real-time monitoring of SUDs due to small sample sizes and low compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review: Wearable remote monitoring to detect nonalcohol/nonnicotine-related substance use disorder symptoms. Oesterle, TS., Karpyak, VM., Coombes, BJ., et al.[2023]

The COMBINE study is a large-scale trial involving 1,375 participants that aims to evaluate the effectiveness of naltrexone and acamprosate, both alone and in combination, alongside behavioral therapies for treating alcohol dependence.

Initial pilot studies indicate that the combination of pharmacotherapy and behavioral interventions is safe and acceptable, suggesting that this multimodal approach could enhance treatment outcomes for individuals with alcohol dependence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testing combined pharmacotherapies and behavioral interventions in alcohol dependence: rationale and methods. [2019]

The study involved 18 participants with alcohol use disorders who received eight sessions of group therapy via videoconferencing over four weeks, with 14 completing at least four sessions and assessments.

Participants reported high satisfaction with the telepsychiatry service, comparable attendance rates to traditional therapy, and 82% would recommend the service, indicating that videoconferencing is a feasible and effective method for delivering therapy to individuals with AUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth service delivery for persons with alcoholism. Frueh, BC., Henderson, S., Myrick, H.[2007]

In a study involving 359 participants who were substance dependent, a telephone-based monitoring and brief counseling intervention (TEL) showed better outcomes for alcohol use compared to standard 12-step group counseling (STND) in individuals with alcohol dependence.

For participants with cocaine dependence, there were no significant differences in abstinence-related outcomes between TEL and the other interventions, indicating that TEL may be particularly effective for those struggling with alcohol rather than cocaine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of telephone-based continuing care in the clinical management of alcohol and cocaine use disorders: 12-month outcomes. McKay, JR., Lynch, KG., Shepard, DS., et al.[2014]

The study analyzed 4593 clients and found that e-therapy programs attracted a different demographic compared to traditional face-to-face treatment, indicating that online options can reduce barriers to accessing help for problem drinking.

Over time, the e-therapy population began to resemble traditional treatment clients more closely, suggesting that as e-therapy becomes more accepted, it may need to maintain anonymity to continue reaching a diverse range of individuals seeking help.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics of problem drinkers in e-therapy versus face-to-face treatment. Postel, MG., de Haan, HA., Ter Huurne, ED., et al.[2022]

The chapter focuses on intervention techniques aimed at reducing hazardous drinking patterns before severe alcohol dependence develops, emphasizing that total abstinence is not the only goal.

The primary objective of these interventions is to lower the quantity and frequency of alcohol consumption to safe levels, promoting moderate and nonproblematic drinking as a common and effective outcome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Techniques to modify hazardous drinking patterns. Miller, WR.[2019]

The telehealth in-home-messaging-device was developed to enhance access to treatment for patients with substance use disorders, addressing barriers like transportation and treatment availability in rural areas.

A pilot study with six outpatient veterans showed that the Substance Use Disorder telehealth management program was well-received, being considered acceptable, easy to use, and helpful in managing their substance use issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an in-home telehealth program for outpatient veterans with substance use disorders. Santa Ana, EJ., Stallings, DL., Rounsaville, BJ., et al.[2019]

Therapeutic models for alcohol dependence should incorporate a comprehensive approach that addresses medical, psychological, and social factors, reflecting the complexity of alcohol misuse.

Strategies based on motivational interviewing and harm reduction can be effectively applied to populations experiencing hazardous and harmful alcohol use, suggesting a need for updated interventions tailored to current patterns of alcohol consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[New patterns of alcohol consumption: what management?]. Plat, A.[2012]

The breathalyser-based eHealth system did not show a significant improvement in self-reported abstinent days compared to the control group, but it did reveal a small positive effect on phosphatidyl ethanol (PEth) levels, indicating some efficacy in monitoring alcohol use.

The study found severe quality issues with the timeline follow-back (TLFB) method for reporting abstinence, as a large percentage of self-reported abstinent days were contradicted by objective eHealth data, suggesting that measurement-based data may be more reliable than self-reports in assessing alcohol use disorder outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breathalyser-Based eHealth Data Suggest That Self-Reporting of Abstinence Is a Poor Outcome Measure for Alcohol Use Disorder Clinical Trials. Hämäläinen, MD., Zetterström, A., Winkvist, M., et al.[2021]

In a study of 4121 patients receiving alcohol use disorder treatment via telehealth, 50.1% retained treatment for 90 days, indicating a significant level of engagement with the program.

Patients showed a substantial reduction in daily estimated peak blood alcohol concentration (BAC), decreasing from a mean of 0.092 on day 1 to 0.038 by day 90, demonstrating the efficacy of telehealth in promoting drinking reductions across various patient subgroups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment retention and reductions in blood alcohol concentration (BAC) during the first 90 days of a telehealth program for alcohol use disorder. Hallgren, KA., Galloway, GP., Witkiewitz, K., et al.[2023]

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 Clinical trial for Alcohol Use | Alcohol Drinking | Drinking Behavior , Multi-Component Breath Alcohol Intervention Phase 3.

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

Multi-Component Intervention for Alcohol Use Disorder ... The available research shows that telehealth services, which are part of the Multi-Component Intervention for Alcohol Use Disorder, are effective. In one study, ...

4. ctv.veeva.com ctv.veeva.com/study/multi-component-breath-alcohol-intervention

Multi-Component Breath Alcohol Intervention (BAMTECH) A three-stage, NIH-funded study to develop and test initially a multi-modal intervention concerning blood/breath alcohol concentration for young adults.

5. 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. •.

6. withpower.com withpower.com/trial/phase-alcohol-drinking-4-2025-845e6

Breath Alcohol Intervention for Alcohol Use Disorder The BAMTECH medical study, being run by Northeastern University, is evaluating whether Multi-Component Breath Alcohol Intervention will have tolerable side ...

7. clinconnect.io clinconnect.io/trials/NCT06994962

Multi-Component Breath Alcohol Intervention Phase 3 ClinConnect Summary. This clinical trial is exploring a new way to help young adults who drink heavily to manage their alcohol consumption.