Behavioral Intervention for Alcohol Use Disorder

Recruiting at 2 trial locations

Overseen By Christine Timko, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: VA Office of Research and Development

Disqualifiers: Cognitive impairment, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

140 Participants Needed

Trial Summary

What is the purpose of this trial?

This pilot study will determine the feasibility, acceptability, and efficacy of Strengths-based Linkage to Alcohol Care (SLAC; a behavioral intervention) to link Veterans, identified as hazardous drinkers in VHA primary care, to alcohol care. Participants screening positive in VA primary care for hazardous drinking and posttraumatic stress disorders (PTSD) and/or depression in the past year will be recruited. Participants will be randomly assigned to one of two study conditions - SLAC plus usual care or usual care only. The investigators will determine the feasibility of conducting a larger scale study to evaluate SLAC in primary care and SLAC's acceptability among key stakeholders (e.g., Veterans, primary care providers). Other outcomes will include exploring whether SLAC improves linkage to an alcohol care or help option and/or reduces alcohol use and mental health (PTSD, depression) symptoms.

Do I have to stop taking my current medications for this trial?

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

What data supports the idea that Behavioral Intervention for Alcohol Use Disorder (also known as: Strengths-based Linkage to Alcohol Care (SLAC)) is an effective treatment?

The available research shows that while there are effective treatments for alcohol use disorder, there is a lack of specific data on the effectiveness of Behavioral Intervention for Alcohol Use Disorder, or SLAC, in the provided information. However, one study mentions the use of brief interventions and referrals to treatment, which are similar approaches, and these have been tested for their ability to reduce alcohol use and promote addiction services. This suggests that similar interventions can be effective, but more specific data on SLAC is needed to confirm its effectiveness. ^{1 2 3 4 5}

What safety data exists for the behavioral intervention for alcohol use disorder?

The provided research does not contain specific safety data for the behavioral intervention known as Strengths-based Linkage to Alcohol Care (SLAC) or similar treatments. The studies focus on gaps in care, pharmacotherapy utilization, and the impact of pharmacotherapies on healthcare systems, but do not address safety data for behavioral interventions. ^{1 6 7 8 9}

Is the treatment Strengths-based Linkage to Alcohol Care (SLAC) a promising treatment for alcohol use disorder?

Yes, SLAC is a promising treatment for alcohol use disorder because it focuses on connecting people to the care they need, which can help fill the gaps in treatment that many people with alcohol use disorder experience. This approach can encourage individuals to seek help and support, making it easier for them to access effective treatments. ^{1 3 7 8 10}

Research Team

Michael A Cucciare, PhD

Principal Investigator

Central Arkansas Veterans Healthcare System , Little Rock, AR

Keith N. Humphreys, PhD MA

Principal Investigator

VA Palo Alto Health Care System, Palo Alto, CA

Eligibility Criteria

This trial is for Veterans who drink hazardously, as shown by an AUDIT-C score over 5, and have had PTSD or depression in the past year. They must not be currently in substance use treatment or weekly support groups, should have a working phone, and someone who knows their contact info.

Inclusion Criteria

Have ongoing access to a mobile or landline telephone

Provide at least one contact who will know the Veteran's contact information

Have screened positive for hazardous drinking (AUDIT-C score > 5)

Exclusion Criteria

Not meeting any of the inclusion criteria

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to either SLAC plus usual care or usual care only, with SLAC being a behavioral intervention to link Veterans to alcohol care

3 months

Multiple visits (in-person and/or virtual)

Follow-up

Participants are monitored for linkage to alcohol care and changes in alcohol consumption, PTSD, and depression symptoms

3 months

Treatment Details

Interventions

• Strengths-based Linkage to Alcohol Care (SLAC)

Trial Overview The study tests SLAC—a behavioral intervention—against usual care to see if it helps link hazardous drinkers with alcohol care services. Participants are randomly placed into two groups: one receives SLAC plus usual care; the other gets only usual care.

Participant Groups

Group I: Strengths-based linkage to alcohol care (SLAC) Experimental Treatment 1 Intervention

SLAC is a behavioral intervention designed to link persons with substance use/misuse to a care or help option

Group II: Usual care Active Control 1 Intervention

Usual care consists of brief intervention in primary care and/or standard referral to more intensive alcohol care (e.g., outpatient/inpatient, pharmacotherapy)

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

The study found that while 81.4% of individuals with alcohol use disorder (AUD) utilized healthcare services and 69.9% were screened for alcohol use, only a small fraction received further care, with just 11.6% receiving a brief intervention and only 5.8% actually receiving treatment.

This highlights a significant gap in the treatment of AUD, suggesting that healthcare settings, especially primary care, could be crucial for implementing effective treatment strategies to improve outcomes for individuals with AUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A cascade of care for alcohol use disorder: Using 2015-2019 National Survey on Drug Use and Health data to identify gaps in past 12-month care. Mintz, CM., Hartz, SM., Fisher, SL., et al.[2023]

Project ENHANCE is a clinical trial involving 450 individuals with untreated alcohol use disorder (AUD) aimed at improving treatment engagement after hospital discharge through various intervention strategies, including brief negotiation interviews and medication initiation.

The study will assess the effectiveness of these interventions on AUD treatment engagement and alcohol use outcomes, while also considering the impact of racial and ethnic disparities, ultimately aiming to inform better hospital-based treatment approaches for diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting alcohol treatment engagement post-hospitalization with brief intervention, medications and CBT4CBT: protocol for a randomized clinical trial in a diverse patient population. Edelman, EJ., Rojas-Perez, OF., Nich, C., et al.[2023]

A systematic approach was used to develop and validate 13 quality indicators for continuing care in individuals with alcohol use disorder (AUD), derived from 69 recommendations across 6 guidelines and 17 existing quality indicators.

The final set includes 10 process indicators and 3 outcome indicators, highlighting the need for further development due to the low level of evidence supporting effective components of continuing care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Validation of Quality Indicators on Continuing Care for Patients With AUD: A Delphi Study. Bekkering, GE., Zeeuws, D., Lenaerts, E., et al.[2017]

A brief intervention using the SBIRT approach significantly reduced heavy drinking days and stimulant use among 718 patients with mental health diagnoses, compared to a health education control group, at a 3-month follow-up.

The SBIRT intervention showed sustained effects on reducing heavy drinking and stimulant use over time, but did not impact cannabis use or increase abstinence rates or addiction treatment service utilization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of screening, brief intervention and referral to treatment for unhealthy alcohol and other drug use in mental health treatment settings: a randomized controlled trial. Karno, MP., Rawson, R., Rogers, B., et al.[2022]

A study involving 78 alcohol-dependent inpatients showed that a self-administered care assessment tool effectively measures treatment outcomes, demonstrating strong agreement with standard clinical assessments.

The tool, which takes about 20 minutes for patients to complete, can help clinicians understand how routine inpatient care impacts alcohol consumption and recovery, with baseline severity being a key predictor of outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does this treatment work? Validation of an outcomes module for alcohol dependence. Rost, KM., Ross, RL., Humphrey, J., et al.[2019]

In a study of U.S. Veterans Affairs patients with alcohol use disorder (AUD) and co-occurring psychiatric disorders, only 7% to 11% received pharmacotherapy for AUD, while 69% to 82% received treatment for their other psychiatric conditions.

The low rates of AUD pharmacotherapy, compared to higher rates for other disorders, highlight a significant gap in treatment access, suggesting a need for improved systems to address barriers to medication for AUD in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative utilization of pharmacotherapy for alcohol use disorder and other psychiatric disorders among U.S. Veterans Health Administration patients with dual diagnoses. Rubinsky, AD., Chen, C., Batki, SL., et al.[2015]

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]

In a study of 10,394 individuals diagnosed with alcohol use disorder (AUD) in Ontario, only a small number received first-line medications like naltrexone and acamprosate, with a dispensing rate of just 3.56 per 1000 population in the year following diagnosis.

The low rate of medication dispensing did not vary significantly between sexes, indicating a potential gap in treatment access for individuals diagnosed with AUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-line medications for alcohol use disorders among public drug plan beneficiaries in Ontario. Spithoff, S., Turner, S., Gomes, T., et al.[2018]

Education sessions significantly increased the dispensing rates of Naltrexone for treating alcohol use disorder, with rates rising 2.47 times, 3.7 times, and 4.81 times after successive presentations.

The study also found that these educational efforts led to a 35% reduction in emergency department visits and a 21% decrease in hospital admissions for alcohol use disorder, highlighting the potential of pharmacotherapy combined with counseling to improve treatment outcomes and reduce healthcare system demands.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How prescribing available pharmacotherapies for alcohol use disorder can impact the healthcare system: A retrospective quality improvement study. Szelest, I., Harries, B., Motluk, L., et al.[2021]

The Alcohol and Wellbeing Self-assessment (A&WS) is a highly feasible and acceptable web-based screening tool, with 81.8% of the 17,628 participants completing it and 95.62% finding it easy to use.

Participants showed significant reductions in alcohol consumption and psychological distress over a 3-month follow-up period, indicating that the A&WS may effectively support individuals in making positive changes, although further randomized controlled trials are needed to confirm these outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary Clinical Outcomes of the Hello Sunday Morning Alcohol and Wellbeing Self-Assessment: Feasibility and Acceptability Study. Fletcher, K., Moran-Pryor, A., Robert-Hendren, D.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

A cascade of care for alcohol use disorder: Using 2015-2019 National Survey on Drug Use and Health data to identify gaps in past 12-month care. [2023]

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

Promoting alcohol treatment engagement post-hospitalization with brief intervention, medications and CBT4CBT: protocol for a randomized clinical trial in a diverse patient population. [2023]

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

Development and Validation of Quality Indicators on Continuing Care for Patients With AUD: A Delphi Study. [2017]

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

Effect of screening, brief intervention and referral to treatment for unhealthy alcohol and other drug use in mental health treatment settings: a randomized controlled trial. [2022]

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

Does this treatment work? Validation of an outcomes module for alcohol dependence. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Comparative utilization of pharmacotherapy for alcohol use disorder and other psychiatric disorders among U.S. Veterans Health Administration patients with dual diagnoses. [2015]

7. 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]

8. Canada pubmed.ncbi.nlm.nih.gov

First-line medications for alcohol use disorders among public drug plan beneficiaries in Ontario. [2018]

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

How prescribing available pharmacotherapies for alcohol use disorder can impact the healthcare system: A retrospective quality improvement study. [2021]

10. Canada pubmed.ncbi.nlm.nih.gov

Preliminary Clinical Outcomes of the Hello Sunday Morning Alcohol and Wellbeing Self-Assessment: Feasibility and Acceptability Study. [2023]