LEAP for Alcohol Use Disorder

(LEAP Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: Inability to consent, Safety risk, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: 3

Duration: 12 months

161 Participants Needed

Trial Summary

What is the purpose of this trial?

People experiencing chronic homelessness comprise a small yet high-morbidity, high-cost subset of the larger homeless population and are disproportionately impacted by alcohol-related harm. Unfortunately, traditional abstinence-based treatment does not adequately reach or engage this population, and both firsthand (problems stemming from one's own alcohol use) and secondhand (problems stemming from others' alcohol use) alcohol-related harm persists even after housing attainment. There have therefore been calls for more flexible and client-centered approaches tailored to this population's needs. Housing First, which entails the provision of immediate, permanent, low-barrier, nonabstinence-based housing, is a response to this call. Research has shown that Housing First is associated with decreased alcohol use, alcohol-related harm, and publicly funded service utilization. Nonetheless, Housing First residents continue to experience both first- and secondhand alcohol-related harm. Thus, further community-based interventions are necessary. To this end, a pilot project was conducted in which researchers as well as Housing First residents, staff and management codeveloped, implemented, and initially evaluated the Life Enhancing Alcohol-management Program (LEAP). The LEAP entails low-barrier, community-level, house-wide resident programming-including leadership opportunities, activities, and pathways to recovery. At the 6-month follow up, LEAP participants reported significantly more engagement in meaningful activities than control participants (p \< .001). Moreover, high levels of LEAP program engagement (\>2 activities per month) predicted significant reductions in alcohol use and alcohol-related harm (ps \< .01). To build on these promising findings, we propose a larger, cluster-randomized controlled trial of LEAP (N=160) as an innovative, community-based, and client-driven adjunct to Housing First. Analyses will test LEAP effectiveness in increasing engagement in meaningful activities, decreasing alcohol use, ameliorating both first- and secondhand alcohol-related harm, and improving quality of life. Engagement in meaningful activities will also be tested as a mediator of the LEAP effect on alcohol and quality-of-life outcomes. Finally, we will assess whether LEAP is associated with reduced costs stemming from participants' use of emergency health-care and criminal justice services.

Will I have to stop taking my current medications?

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

What safety data exists for LEAP treatment in humans?

The safety of pharmacological treatments for alcohol use disorder (AUD) varies, with some medications like acamprosate, naltrexone, nalmefene, and disulfiram being approved in certain regions. Safety considerations include the impact of high alcohol consumption, other health conditions, and additional medications. Each treatment has a unique safety profile that should be considered alongside the treatment goals and patient preferences. ^{1 2 3 4 5}

Research Team

Seema L Clifasefi, PhD MSW

Principal Investigator

University of Washington

Eligibility Criteria

This trial is for current DESC clients living in certain Housing First sites who have a history of chronic homelessness and at-risk drinking. To join, men must score over 3 and women over 2 on the AUDIT-C screening. Participants must be able to consent to research and not pose a safety risk.

Inclusion Criteria

At-risk drinking as established by the AUDIT-C at screening (cut-off scores: men >= 3, women >= 2)

Having a history of chronic homelessness according to the widely accepted federal definition (i.e., having a psychiatric, medical, or substance use disorder paired with being homeless for a year or more or having 4 or more episodes of homelessness in the past 3 years)

Being a current DESC client living in 1 of 10 participating Housing First sites

Exclusion Criteria

Constituting a risk to the safety and security of other clients or staff

I am unable or unwilling to give consent for research participation.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in the Life Enhancing Alcohol-management Program (LEAP) activities, including leadership opportunities and pathways to recovery, as part of a 12-month intervention

12 months

Monthly engagement in activities

Follow-up

Participants are monitored for changes in alcohol use, quality of life, and service utilization costs

12 months

3, 6, and 12-month follow-up assessments

Treatment Details

Interventions

• LEAP

Trial Overview The LEAP program is being tested as an adjunct to Housing First housing. It's a community-based initiative offering leadership opportunities, activities, and recovery pathways aimed at reducing alcohol use and related harm while improving engagement in meaningful activities.

Participant Groups

Group I: LEAP Active Control 1 Intervention

Housing First plus LEAP

Group II: Service-As-Usual Active Control 1 Intervention

Housing First

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+

Washington State University

Collaborator

Trials

114

Recruited

58,800+

Findings from Research

Alcohol use disorder (AUD) is common but often under-treated, with only three approved medications, highlighting the need for more diverse and effective treatment options.

The review discusses various pharmacotherapies, including both approved and novel agents, showing promise for improving treatment efficacy and supporting personalized medicine approaches for individuals with AUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel Agents for the Pharmacological Treatment of Alcohol Use Disorder. Burnette, EM., Nieto, SJ., Grodin, EN., et al.[2022]

A significant gap exists in the treatment of alcohol use disorder (AUD), as only 20.5% of individuals with severe AUD received treatment despite high rates of healthcare utilization and screening for alcohol use.

The study highlights that while many individuals with AUD are screened in healthcare settings, there is a substantial drop-off in receiving brief interventions and referrals to treatment, indicating a critical opportunity for improving pharmacologic treatment implementation in primary care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Cascade of Care for Alcohol Use Disorder: Using 2015-2018 National Survey on Drug Use and Health Data to Identify Gaps in Care. Mintz, CM., Hartz, SM., Fisher, SL., et al.[2022]

Pharmacological treatments for alcohol use disorders (AUD), such as acamprosate, naltrexone, nalmefene, and disulfiram, are effective but underused, highlighting the need for better implementation despite their proven efficacy.

Each medication has a distinct safety profile that must be carefully considered alongside individual patient circumstances, including their drinking patterns and any comorbid conditions, to optimize treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Tolerability of Pharmacological Treatment of Alcohol Dependence: Comprehensive Review of Evidence. Sinclair, JM., Chambers, SE., Shiles, CJ., et al.[2018]

Current medications for alcohol use disorder (AUD), including disulfiram, naltrexone, acamprosate, and the newly approved nalmefene, have limited efficacy, benefiting only a small number of individuals with AUD.

Research is ongoing to develop new medications targeting various pharmacological pathways, with a focus on improving effectiveness and safety, which is crucial for better treatment outcomes for patients with AUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in Pharmacotherapy Development: Human Clinical Studies. Litten, RZ., Falk, DE., Ryan, ML., et al.[2022]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Novel Agents for the Pharmacological Treatment of Alcohol Use Disorder. [2022]

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

A Cascade of Care for Alcohol Use Disorder: Using 2015-2018 National Survey on Drug Use and Health Data to Identify Gaps in Care. [2022]

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

Medications for Alcohol Use Disorder and Retention in Care in Medicaid-Enrolled Youth, 2014-2019. [2023]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Safety and Tolerability of Pharmacological Treatment of Alcohol Dependence: Comprehensive Review of Evidence. [2018]

5. Germany pubmed.ncbi.nlm.nih.gov

Advances in Pharmacotherapy Development: Human Clinical Studies. [2022]