eHaRT-A for Alcoholism

(eHaRT-A Trial)

Overseen By Tessa Frohe, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University of Washington

Disqualifiers: Other treatment studies, Safety risk, others

No Placebo Group All 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 Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 3 months

160 Participants Needed

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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

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

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

Group I: Housing First + eHaRT-A Experimental Treatment 1 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 Usual Active Control 1 Intervention

Housing First as usual includes housing provision and management, fulfillment of basic needs (e.g., food, clothing), nursing/medical services and case management.

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

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 e-therapy program for problem drinkers, involving therapist support, led to a significant reduction in alcohol consumption and related health issues among 527 Dutch-speaking patients, despite a high dropout rate.

Patient satisfaction with the e-therapy was high, indicating its feasibility and potential to engage individuals who might not typically seek help for alcohol-related problems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of an e-therapy program for problem drinkers: a pilot study. Postel, MG., De Haan, HA., De Jong, CA.[2019]

Various treatment methods for alcoholism, including chemotherapy, psychotherapy, behavior modification, and Alcoholics Anonymous, have shown success but each has its own limitations and potential risks.

Effective treatment for alcoholism necessitates long-term follow-up and often involves family participation to ensure the best outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rehabilitation for alcoholics. Smith, JW.[2019]

The COMBINE Study successfully adapted the Systematic Assessment for Treatment Emergent Events (SAFTEE) to standardize the assessment of adverse events for naltrexone and acamprosate in treating alcohol dependence, ensuring consistent and reliable data collection.

The SAFTEE demonstrated high fidelity and flexibility in measuring adverse events across various settings, suggesting it could be a valuable tool for future clinical studies evaluating the safety and efficacy of new therapeutic drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The COMBINE SAFTEE: a structured instrument for collecting adverse events adapted for clinical studies in the alcoholism field. Johnson, BA., Ait-Daoud, N., Roache, JD.[2019]

Acamprosate, when used alongside psychosocial treatment, is effective in helping alcohol-dependent patients maintain abstinence, as shown in a review of 13 clinical trials involving 4234 participants.

The treatment is generally safe, with mild to moderate side effects like diarrhea and flatulence, and it can be used in patients with liver issues, although a dose reduction is advised for those with kidney problems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acamprosate: safety and tolerability in the treatment of alcohol dependence. Rosenthal, RN., Gage, A., Perhach, JL., et al.[2011]

About 13.5% of American adults use prescription medications that interact with alcohol, and among these, 5.6% consume three or more alcoholic drinks on each occasion, highlighting a significant risk for adverse effects.

Certain groups, such as men aged 20-54 and current smokers, are more likely to combine alcohol with these medications, suggesting a need for better screening and communication about the dangers of mixing alcohol with alcohol-interactive medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A profile of concurrent alcohol and alcohol-interactive prescription drug use in the US population. Jalbert, JJ., Quilliam, BJ., Lapane, KL.[2022]

The expansion of coverage for acamprosate and naltrexone in Ontario significantly increased their utilization rates among individuals with alcohol use disorder (AUD), with acamprosate use rising by 98.1% after coverage expansion.

However, a subsequent shortage of acamprosate led to a dramatic 98.1% drop in its use, while naltrexone prescribing remained unaffected, indicating that the availability of specific medications can greatly influence treatment options for AUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of policy changes and drug shortages on acamprosate and naltrexone use in Ontario, Canada. Konstantelos, N., Tourchian, N., McCormack, D., et al.[2023]

From 1980 to 2003, the rate of repeat adverse drug reactions (ADRs) leading to hospitalization in older Australians increased significantly, with repeat ADRs accounting for 30.3% of all ADRs by 2003.

The most common repeat ADRs included nausea/vomiting and hemorrhage from anticoagulants, highlighting the need for improved safety measures, especially for anticoagulants and antineoplastic drugs, which were frequently implicated in these repeat incidents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repeat adverse drug reactions causing hospitalization in older Australians: a population-based longitudinal study 1980-2003. Zhang, M., Holman, CD., Preen, DB., et al.[2018]

References

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

Alcoholism treatment in the United States. An overview. [2023]

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

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

3. England pubmed.ncbi.nlm.nih.gov

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

4. England pubmed.ncbi.nlm.nih.gov

Evaluation of an e-therapy program for problem drinkers: a pilot study. [2019]

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

Rehabilitation for alcoholics. [2019]

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

The COMBINE SAFTEE: a structured instrument for collecting adverse events adapted for clinical studies in the alcoholism field. [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Acamprosate: safety and tolerability in the treatment of alcohol dependence. [2011]

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

A profile of concurrent alcohol and alcohol-interactive prescription drug use in the US population. [2022]

9. Ireland pubmed.ncbi.nlm.nih.gov

Impact of policy changes and drug shortages on acamprosate and naltrexone use in Ontario, Canada. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Repeat adverse drug reactions causing hospitalization in older Australians: a population-based longitudinal study 1980-2003. [2018]