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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program called LEAP, a therapeutic intervention designed to assist individuals in Housing First communities who face alcohol use issues. The goal is to determine if LEAP can increase participation in meaningful activities, reduce alcohol consumption, and lower alcohol-related problems, thereby improving overall quality of life. The trial compares LEAP to the usual Housing First approach to identify which is more effective. It is suitable for individuals with a history of chronic homelessness who currently live in a Housing First site and have been identified as at-risk drinkers. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance support for at-risk drinkers in Housing First communities.

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 prior data suggests that the LEAP program is safe for participants?

Research has shown that the Life Enhancing Alcohol-management Program (LEAP) has been studied within the Housing First approach for individuals with alcohol use disorder. In earlier studies, participants in LEAP reported engaging in more meaningful activities, which helped them reduce alcohol consumption and experience fewer alcohol-related issues. Although specific safety details for LEAP are not provided, the program emphasizes community activities rather than medications or medical procedures, suggesting a lower risk of serious side effects compared to drug-based treatments.

As LEAP is part of a larger supportive housing program, it likely shares the safe nature of similar community-based programs. For those considering joining a trial with LEAP, the focus on activities and community support suggests it is likely safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for Alcohol Use Disorder, which often focus on medication-assisted therapy or behavioral interventions, LEAP is unique because it combines the Housing First approach with a specialized intervention. Housing First provides stable housing as a foundation, which is believed to support recovery better than traditional methods that might require sobriety before housing. Researchers are excited about LEAP because it integrates life-skills training and personalized support directly within the housing environment, potentially offering a more holistic and supportive path to recovery. This approach could address the root causes of alcohol use disorder more effectively, offering hope for improved outcomes.

What evidence suggests that the LEAP program is effective for reducing alcohol-related harm in people experiencing chronic homelessness?

Research shows that the Life Enhancing Alcohol-management Program (LEAP) helps people with alcohol use disorder drink less and experience fewer negative effects from alcohol. This trial will assign participants to either the LEAP program or a Service-As-Usual group. An initial study found that participants in LEAP engaged in more meaningful activities and significantly reduced their alcohol use compared to those not in the program. High involvement in the program, defined as participating in more than two activities each month, led to a noticeable drop in alcohol-related problems. These results suggest that LEAP can not only help reduce drinking but also improve overall quality of life by encouraging participation in positive, community-based activities. ^{1 6 7 8 9}

Who Is on the Research Team?

Seema L Clifasefi, PhD MSW

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11142616/

Outcomes of the LEAP feasibility trial—A low-threshold, ... The retention rate was 45% (n = 14) to the main recruitment site. Adherence to the exercise sessions and nutritional intervention was 90% and ...

2. wellcomeleap.org wellcomeleap.org/ua/program/

Untangling Addiction Program Details For alcohol addiction, studies have shown relapse rates of approximately 50% within the first three months after completion of intensive inpatient programs. One ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04302740

Life Enhancing Alcohol-management Program (LEAP) LEAP effectiveness in reducing alcohol use and alcohol-related harm and improving QoL. Compared to controls, LEAP participants will report less alcohol use ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2949875925001729

Quality of life assessment instruments used in clinical trials ... Quality of life (QoL) measures are increasingly used as outcome indicators in both pharmacological and non-pharmacological intervention ...

5. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2024.1396855/full

Clinical characteristics and 6-month follow-up of adults with ... Our findings suggest that the short-term risk of subsequent suicidal behavior may be elevated in patients with AUD. Educational interventions to ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9887652/

Predictors of Abstinence, No Heavy Drinking Days, and a 2 ... Data from trials of medications for alcohol use disorder (AUD) can be used to identify predictors of drinking outcomes regardless of treatment, ...

7. nature.com nature.com/articles/s41380-025-03259-8

Crosstalk between alcohol use disorder and obesity: two ... Furthermore, AUD and obesity often present with similar medical consequences related to organ damage, including liver and cardiovascular ...

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1111/acer.14877

Predictors of abstinence, no heavy drinking days, and a 2‐ ... Data from trials of medications for alcohol use disorder (AUD) can be used to identify predictors of drinking outcomes regardless of ...

9. bmjopen.bmj.com bmjopen.bmj.com/content/13/5/e069249

Effect of environmental enrichment on relapse rates in ... This study aims at assessing the effectiveness of exposure to a newly designed EE protocol during AUD treatment in reducing relapse to alcohol use.