Medication + Cognitive Behavioral Therapy for Substance Use Disorder

(CARE-VASH Trial)

Overseen By Sonya E Gabrielian, MD MPH

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments to assist Veterans who have experienced homelessness and are part of the HUD-VASH program. It focuses on medication for addiction treatment (MAT) and cognitive behavioral therapy for substance use disorders (CBT-SUD) to reduce substance use and prevent a return to homelessness. The trial includes different groups: one receives standard support, another receives a training and support program, and the third adds educational materials and peer coaching. Veterans who have been homeless and are currently in the HUD-VASH program can join. As an unphased trial, this study offers Veterans a unique opportunity to access innovative support strategies that could significantly improve their quality of life.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study showed that cognitive behavioral therapy for substance use disorders (CBT-SUD) works well both on its own and when combined with other treatments. CBT carries little risk, although it might sometimes bring up uncomfortable feelings.

Research has also shown that medications for addiction treatment (MAT) are safe and effective. These medications, often used for issues like opioid addiction, do not harm a person's intelligence or physical abilities. Both CBT-SUD and MAT have strong safety records, making them trustworthy options for treating substance use disorders. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how combining Medication for Addiction Treatment (MAT) with Cognitive Behavioral Therapy for Substance Use Disorders (CBT-SUD) might enhance recovery outcomes. Unlike typical standalone treatments, this approach integrates medication with behavioral strategies, potentially offering a more comprehensive solution. Additionally, the trial investigates innovative implementation strategies, like stakeholder-informed training and consumer engagement, which could make these therapies more accessible and effective in real-world settings. This holistic approach aims to address both the physiological and psychological aspects of substance use disorder, offering hope for more sustainable recovery solutions.

What evidence suggests that this trial's treatments could be effective for substance use disorder?

Research has shown that Cognitive Behavioral Therapy for Substance Use Disorders (CBT-SUD) can help reduce substance use. It is effective both alone and in combination with other treatments. Studies have found that CBT can make a noticeable difference within the first 1–6 months of treatment. Similarly, Medications for Addiction Treatment (MAT) have proven effective in reducing substance use, improving health, and lowering the risk of overdose. Research also indicates that medications like buprenorphine and methadone can decrease the need for emergency care related to opioid use. In this trial, some participants will receive CBT-SUD and MAT as part of the REP + Consumer Engagement (CE) arm, which includes educational materials, peer coaching, and a toolkit to support implementation. Both treatments have strong evidence supporting their effectiveness in treating substance use disorders. ^{1 2 6 7 8}

Who Is on the Research Team?

Sonya Emi Gabrielian, MD MPH

Principal Investigator

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Emily Treichler, PhD

Principal Investigator

VA San Diego Healthcare System, San Diego, CA

Evelyn T Chang, MD MSHS

Principal Investigator

VA Greater Los Angeles Healthcare System, Sepulveda, CA

Erin P Finley, PhD MPH

Principal Investigator

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Are You a Good Fit for This Trial?

This trial is for Veterans who have experienced homelessness and are dealing with substance use disorders. They must be part of the HUD-VASH program, which provides housing and case management. Specific eligibility criteria were not provided.

Inclusion Criteria

Homeless-experienced Veterans (HEVs) enrolled in the Department of Housing and Urban Development-VA Supportive Housing (HUD-VASH) Program.

Exclusion Criteria

N/A

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of evidence-based practices (EBPs) for SUDs, including Medications for Addiction Treatment (MAT) and cognitive behavioral therapy for SUDs (CBT-SUD) in 12 HUD-VASH sites

18 months

Regular visits for MAT and CBT-SUD sessions

Follow-up

Participants are monitored for the sustainment and reach of MAT and CBT-SUD, as well as housing retention and provider experience

9-18 months

Evaluation

Evaluation of the impacts of REP vs. REP+CE, including budget impact analysis and development of an implementation playbook

18-27 months

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Behavioral Therapy for Substance Use Disorders (CBT-SUD)
• Medication for Addiction Treatment (MAT)

Trial Overview The study tests how effective Medication for Addiction Treatment (MAT) and Cognitive Behavioral Therapy for Substance Use Disorders (CBT-SUD) are in helping Veterans within the HUD-VASH program to manage their addiction issues.

How Is the Trial Designed?

Group I: Replicating Effective Programs (REP) Experimental Treatment 2 Interventions

A stakeholder-informed training and technical assistance implementation strategy

Group II: Control Group Active Control 1 Intervention

No MAT or CBT-SUD implementation

Group III: REP + Consumer Engagement (CE) Active Control 2 Interventions

REP plus CE package (educational materials, peer coaching, toolkit) to support MAT and CBT-SUD implementation.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

University of California, Los Angeles

Collaborator

Trials

1,594

Recruited

10,430,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2897895/

Cognitive-Behavioral Therapy for Substance Use Disorders Cognitive behavioral therapy (CBT) for substance use disorders has demonstrated efficacy as both a monotherapy and as part of combination treatment strategies.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10572095/

An Evaluation of Cognitive Behavioral Therapy for ... CBT produced small to moderate effects on substance use when compared to inactive treatment and was most effective at early follow-up (1–6 months post-treatment) ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0376871625002091

Cognitive-behavioral interventions for co-occurring ... The current meta-analysis provides an overview of cognitive-behaviorally-based interventions (CBI) that treat co-occurring alcohol and other drug use (AOD)

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2767358

Combined Pharmacotherapy and Cognitive Behavioral ... This meta-analysis and systemic review assess combined cognitive behavioral therapy and pharmacotherapy for alcohol or other substance use ...

5. dovepress.com dovepress.com/efficacy-of-cognitive-behavioral-therapy-for-alcohol-and-other-drug-us-peer-reviewed-fulltext-article-SAR

Efficacy of CBT for substance use disorders | SAR A survey of US treatment facilities shows 96% of program administrators report use of relapse prevention and 94% report use of CBT, and these ...

6. mayoclinic.org mayoclinic.org/tests-procedures/cognitive-behavioral-therapy/about/pac-20384610

Cognitive behavioral therapy In general, there's little risk in getting cognitive behavioral therapy. But you may feel emotions that aren't comfortable at times. This is ...

7. cdc.gov cdc.gov/overdose-prevention/treatment/index.html

Treatment of Substance Use Disorders There are safe and effective ways to recover from SUDs. Finding the right treatment option can be the key to a successful recovery journey.

8. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2025.1486338/full

The effects of cognitive behavioral therapy-based digital ... These findings suggest that digital CBT-based interventions can be an effective alternative to face-to-face CBT for reducing alcohol use and related symptoms.