160 Participants Needed

eHaRT-A for Alcoholism

(eHaRT-A Trial)

ET
TF
Overseen ByTessa Frohe, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: University of Washington
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment eHaRT-A for alcoholism?

The evaluation of an e-therapy program for problem drinkers showed a significant decrease in alcohol consumption and related health issues, suggesting that online therapy can be effective for reducing alcohol use.12345

What safety data exists for eHaRT-A or similar treatments for alcoholism?

The safety of acamprosate, a treatment for alcohol dependence, has been evaluated in multiple clinical trials. In these studies, the overall incidence of adverse events was similar between those taking acamprosate and those taking a placebo, suggesting it is generally safe for use in humans.678910

What is the purpose of this trial?

The goal of this project is to transform a successful, face-to-face harm-reduction treatment (HaRT-A) into a digital format, creating eHaRT-A. This new platform is specifically designed for people who have experienced homelessness and an alcohol use disorder (AUD), living within the framework of permanent, supportive, Housing First (HF) facilities. We hypothesize eHaRT-A will be more effective than the standard HF services in reducing alcohol-related harm and improving the overall quality of life for participants.

Research Team

TF

Tessa Frohe, PhD

Principal Investigator

University of Washington

Eligibility Criteria

This trial is for English-speaking adults over 21 who are registered at Housing First sites, currently drink alcohol, and meet the criteria for an Alcohol Use Disorder (AUD) as per the Diagnostic and Statistical Manual of Mental Health Disorders.

Inclusion Criteria

Currently drinking (has used alcohol in the past 2 weeks)
Speaking English fluently
Currently a registered client at one of the Housing First sites
See 2 more

Exclusion Criteria

Enrollment in any related treatment studies (including studies by this research team)
I cannot or do not want to give consent for treatment.
Constituting a risk to the safety and security of residents or staff

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the eHaRT-A intervention, which includes tracking alcohol-related harm, setting harm-reduction goals, and discussing safer-drinking strategies

3 months
Virtual sessions

Follow-up

Participants are monitored for changes in quality of life, alcohol consumption, and harm reduction outcomes

3 months
1- or 3-month follow-up

Treatment Details

Interventions

  • eHaRT-A
Trial Overview The study is testing eHaRT-A, a digital version of a face-to-face harm-reduction treatment designed for people with AUD who have experienced homelessness. It aims to see if it's more effective than standard services in reducing alcohol-related harm.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Housing First + eHaRT-AExperimental Treatment1 Intervention
HaRT-A comprises three concrete treatment components: 1) measurement and participant-led tracking of indicators of alcohol-related harm (e.g., number of drinks, blackouts), 2) elicitation of harm-reduction and health related quality of life (HRQoL) goals (e.g., drink slower, eat healthier, reconnect with family), and 3) discussion of safer-drinking strategies (e.g., taking B-complex vitamins, eating prior to or during alcohol use, avoiding mixing alcohol and other drugs). HaRT-A honors community representation within harm-reduction intervention development and acknowledges the larger forces (familial, community, geopolitical) at play in substance use, thus emphasizing the wisdom of the participant in defining their own pathway to recovery.
Group II: Housing First As UsualActive Control1 Intervention
Housing First as usual includes housing provision and management, fulfillment of basic needs (e.g., food, clothing), nursing/medical services and case management.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials
1,858
Recruited
2,023,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials
865
Recruited
1,091,000+

Findings from Research

Detoxification is often the first step in alcoholism treatment for over 700,000 people in the U.S. daily, and it can be combined with behavioral therapies like cognitive-behavioral therapy and Alcoholics Anonymous.
A major clinical study, Project MATCH, found no significant differences in outcomes among various behavioral treatment approaches, suggesting that the choice of therapy may depend more on individual patient characteristics rather than the type of therapy itself.
Alcoholism treatment in the United States. An overview.Fuller, RK., Hiller-Sturmhöfel, S.[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.
Testing combined pharmacotherapies and behavioral interventions in alcohol dependence: rationale and methods.[2019]
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.
Characteristics of problem drinkers in e-therapy versus face-to-face treatment.Postel, MG., de Haan, HA., Ter Huurne, ED., et al.[2022]

References

Alcoholism treatment in the United States. An overview. [2023]
Testing combined pharmacotherapies and behavioral interventions in alcohol dependence: rationale and methods. [2019]
Characteristics of problem drinkers in e-therapy versus face-to-face treatment. [2022]
Evaluation of an e-therapy program for problem drinkers: a pilot study. [2019]
Rehabilitation for alcoholics. [2019]
The COMBINE SAFTEE: a structured instrument for collecting adverse events adapted for clinical studies in the alcoholism field. [2019]
Acamprosate: safety and tolerability in the treatment of alcohol dependence. [2011]
A profile of concurrent alcohol and alcohol-interactive prescription drug use in the US population. [2022]
Impact of policy changes and drug shortages on acamprosate and naltrexone use in Ontario, Canada. [2023]
Repeat adverse drug reactions causing hospitalization in older Australians: a population-based longitudinal study 1980-2003. [2018]
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