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

115 Participants Needed

Trial Summary

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 data supports the idea that Multi-Component Intervention for Alcohol Use Disorder is an effective treatment?

The available research shows that telehealth services, which are part of the Multi-Component Intervention for Alcohol Use Disorder, are effective. In one study, participants who received group therapy through videoconferencing reported high satisfaction and found the treatment credible. They also had good attendance, similar to traditional in-person therapy, and 82% would recommend it to others. Another study found that a telephone-based intervention led to better outcomes for alcohol use compared to standard group counseling in participants with alcohol dependence. These findings suggest that Multi-Component Intervention, which includes telehealth, is a promising treatment for alcohol use disorder. ^{1 2 3 4 5}

What safety data exists for the Multi-Component Intervention for Alcohol Use Disorder?

The available research suggests that telehealth-based interventions for alcohol use disorder, which may include components like breathalyzer monitoring and counseling, are feasible and acceptable to patients. Studies indicate that these interventions can lead to significant reductions in blood alcohol concentration over time, suggesting they are effective in promoting safer drinking behaviors. However, specific safety data for the Multi-Component Intervention under its various names is not directly addressed in the provided research abstracts. ^{1 3 6 7 8}

Is the Multi-Component Breath Alcohol Intervention a promising treatment for Alcohol Use Disorder?

Yes, the Multi-Component Breath Alcohol Intervention is promising because it combines different methods like telehealth counseling and psychoeducation to help people manage their drinking. This approach can reduce risky alcohol use and support moderate drinking, making it a valuable option for those seeking help with alcohol use disorder. ^{3 9 10 11 12}

What is the purpose of this trial?

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.

Research Team

Robert F Leeman, PhD.

Principal Investigator

Northeastern University

Eligibility Criteria

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 drink alcohol often.

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

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 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]

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]

References

1. England 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. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Telehealth service delivery for persons with alcoholism. [2007]

3. Ireland pubmed.ncbi.nlm.nih.gov

The remote brief intervention and referral to treatment model: Development, functionality, acceptability, and feasibility. [2018]

4. United States 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. [2014]

5. England pubmed.ncbi.nlm.nih.gov

Characteristics of problem drinkers in e-therapy versus face-to-face treatment. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Development of an in-home telehealth program for outpatient veterans with substance use disorders. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Systematic review: Wearable remote monitoring to detect nonalcohol/nonnicotine-related substance use disorder symptoms. [2023]

8. England 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. [2023]

9. England pubmed.ncbi.nlm.nih.gov

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

10. France pubmed.ncbi.nlm.nih.gov

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

11. United States pubmed.ncbi.nlm.nih.gov

Techniques to modify hazardous drinking patterns. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Evaluation of an electronic clinical reminder to facilitate brief alcohol-counseling interventions in primary care. [2022]