Virtual Incentive Treatment for Alcoholism

(VITA Trial)

Overseen By Julianne Jett, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington State University

Disqualifiers: Severe substance use disorder, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 26 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore a new method to support individuals with alcohol use disorder (AUD) through telehealth and virtual incentives, known as Virtual Incentive Treatment. Participants will be randomly assigned to one of two groups, both receiving online cognitive behavioral therapy (CBT) for 26 weeks. One group will receive rewards for alcohol-free blood tests, while the other will receive rewards for simply submitting samples. Suitable participants should have experienced recent heavy drinking episodes and not be currently receiving treatment for AUD. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could shape future AUD treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that participants should not be receiving treatment for alcohol use disorder (AUD) or be enrolled in another alcohol treatment study.

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

Research has shown that using virtual incentives through telehealth, combined with a blood test called phosphatidylethanol (PEth), holds promise for managing alcohol use disorder. PEth is a blood marker that can detect alcohol use for up to 28 days, allowing monitoring without frequent doctor visits.

Earlier studies found this method well-received, with participants typically not experiencing severe side effects. The approach uses incentives to encourage positive behavior and is generally safe. By incorporating cognitive behavioral therapy and incentives, it avoids the risks associated with medications.

The study is currently in a phase where safety is still being evaluated, but previous research has not identified major safety concerns. Since this treatment doesn't involve new drugs, it usually carries fewer risks. Participants can feel reassured knowing that the focus is on behavioral change, which is generally safe and supportive. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Virtual Incentive Treatment for alcoholism because it combines cognitive behavioral therapy (CBT) with innovative digital incentives to encourage sobriety. Unlike traditional treatments such as medication or in-person therapy, this approach uses a web-based program called CBT4CBT, which allows participants to learn at their own pace through videos and lessons. The unique aspect of this treatment is its use of virtual incentives, where participants earn rewards based on their progress in reducing alcohol consumption, creating a personalized and motivating experience. This method aims to enhance engagement and adherence, potentially leading to better outcomes compared to standard care options.

What evidence suggests that this trial's treatments could be effective for alcoholism?

Research shows that a telehealth-based reward system can effectively help people with alcohol use disorder (AUD) reduce their drinking. In this trial, participants in the CM Condition (Contingency Management + CBT4CBT) receive incentives based on their PEth test results, which previous studies have found promising. One study showed that 71% of participants using a similar reward system stayed alcohol-free for more than four weeks, compared to just 21% in the usual treatment group. Additionally, 43% of participants in the reward system remained alcohol-free for over 24 weeks. This approach uses a blood test called phosphatidylethanol (PEth) to check for alcohol use and offers incentives for staying alcohol-free. These findings suggest that this virtual reward treatment could be a promising way to support those trying to cut down or stop drinking. ^{1 3 4 6 7}

Who Is on the Research Team?

Nathalie Hill-Kapturczak, PhD

Principal Investigator

University of Texas Health San Antonio

Sean Murphy, PhD

Principal Investigator

Weill Cornell

Michael McDonell, PhD

Principal Investigator

Washington State University Elson S. Floyd College of Medicine

Are You a Good Fit for This Trial?

This trial is for adults with Alcohol Use Disorder (AUD) who are willing to participate in a telehealth-based study. Participants will be recruited online and must be comfortable submitting blood samples. The study excludes individuals not meeting the specific requirements set by the researchers.

Inclusion Criteria

Are not receiving treatment for AUD

I am over 18 years old.

I can do study visits over Zoom.

Exclusion Criteria

Have a current diagnosis of severe substance use disorder (other than AUD, tobacco, and cannabis)

PEth biomarker ≤ 20 ng/mL (indicates no heavy drinking in past month)

Alcohol withdrawal-related seizure or hospitalization in prior 12 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 26-week telehealth-based CM intervention with PEth testing and CBT4CBT

26 weeks

Weekly visits initially, then bi-weekly and monthly

Follow-up

Participants are monitored for alcohol abstinence and related outcomes

12 months

Monthly visits

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Incentive Treatment

Trial Overview The trial tests a virtual treatment program using an online cognitive behavioral therapy (CBT4CBT) combined with incentives based on abstinence from alcohol, verified through a blood biomarker called PEth. It compares this approach against CBT4CBT with incentives just for providing blood samples, without requiring abstinence.

How Is the Trial Designed?

Group I: CM Condition (Contingency Management + CBT4CBT) Experimental Treatment 2 Interventions

Participants will receive 8 weeks of CBT4CBT and incentives for timely shipping. In addition, those in the CM Condition will receive at least $20 for each PEth-negative sample. Participants will receive an additional $5 for each week of consecutive negative PEth tests, with a $90 cap. In Initiation Phase, participants will attend virtual visits, provide PEth samples, and be rewarded for a decrease in PEth weekly. Maintenance Phase will begin when a participant's PEth sample is \< 20 ng/mL. In Maintenance Phase, participants will attend visits and submit PEth samples every two weeks for four weeks (i.e., weeks 6 \& 8). They will then attend visits and submit PEth samples every four weeks (weeks 12, 16, 20, 24), and on week 26. If participants submit a positive PEth sample, they will return to Initiation Phase and receive $20 for their next negative sample. Participants will attend visits and submit samples weekly until their PEth level is \< 20 ng/mL and they restart Maintenance Phase.

Group II: Control Condition (Non-contingent Incentives + CBT4CBT) Active Control 1 Intervention

Participants will receive 8 weeks of Computer Based Training for Cognitive Behavioral Health (CBT4CBT). CBT4BCT is a self paced web-based program that uses videos and lessons to help people learn skills they can use to cut down or stop drinking. Participants will receive a $10 e-gift card for every PEth sample submitted within 48 hours of the visit regardless of the result. Participants will receive gift card incentives when they attend visits and provide blood samples (PEth Samples). Participants will submit PEth samples weekly for the first four weeks of the study, then every two weeks (weeks six, eight), then every four weeks (weeks 12,16, 20, 24), and at week 26. Each time they submit a PEth sample, they will receive gift cards equal to the average CM earnings during the previous month, resulting in total average earnings equivalent to the CM group. This group will receive incentives regardless of the results of their PEth tests.

Who Is Running the Clinical Trial?

Washington State University

Lead Sponsor

Trials

114

Recruited

58,800+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

The University of Texas Health Science Center at San Antonio

Collaborator

Trials

486

Recruited

92,500+

Weill Medical College of Cornell University

Collaborator

Trials

1,103

Recruited

1,157,000+

Published Research Related to This Trial

Computer-based interventions for drug use disorders have shown high acceptability and can lead to reduced substance use, increased motivation to change, and better retention compared to traditional treatment methods, based on a review of 12 studies.

These interventions offer a promising alternative due to their lower cost and greater accessibility, suggesting they could significantly transform treatment approaches for drug use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-based interventions for drug use disorders: a systematic review. Moore, BA., Fazzino, T., Garnet, B., et al.[2022]

An online alcohol check-up program was developed and tested with 1,455 participants over 25 months, revealing that 83% had scores indicating problem drinking, highlighting the program's potential to reach individuals with untreated alcohol issues.

Participants with higher ambivalence about their drinking found the automated program particularly helpful, suggesting that computer-administered therapy can effectively engage those motivated to change their substance use behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determinants of satisfaction with an automated alcohol evaluation program. Lieberman, DZ.[2019]

This study will compare the effectiveness of a web-based relapse prevention therapy (e-RPT) to traditional face-to-face therapy (RPT) for adults with alcohol use disorder (AUD), involving 60 participants over 10 sessions.

The research aims to demonstrate that e-RPT can reduce relapse rates and improve quality of life, self-efficacy, and resilience, while also being more accessible and cost-effective than traditional therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing and Implementing a Web-Based Relapse Prevention Psychotherapy Program for Patients With Alcohol Use Disorder: Protocol for a Randomized Controlled Trial. Eadie, J., Gutierrez, G., Moghimi, E., et al.[2023]

Mobile phone systems for treating alcohol-use disorders (AUDs) are categorized into four groups, with comprehensive recovery management systems showing the strongest theoretical support and longest-lasting effects.

While text-messaging applications may offer some benefits, they are likely not sufficient as standalone interventions for AUDs, highlighting the need for more robust and evidence-based solutions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Delivery of Treatment for Alcohol Use Disorders: A Review of the Literature. Quanbeck, A., Chih, MY., Isham, A., et al.[2022]

A pilot study involving 32 adult men with alcohol use disorder showed that synchronous internet-mediated relapse prevention therapy (i-RPT) is feasible and acceptable, with 71.9% of participants completing all five sessions.

The therapy demonstrated modest effectiveness, leading to significant increases in days of abstinence and reductions in alcohol consumption, craving, and maladaptive coping behaviors, suggesting it could be a valuable tool for managing alcohol use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and preliminary effectiveness of internet-mediated 'relapse prevention therapy' for patients with alcohol use disorder: A pilot study. Sharma, A., Das, K., Sharma, S., et al.[2022]

The National Institute on Drug Abuse (NIDA) is prioritizing the development of incentive-based interventions for treating substance use disorders (SUDs), emphasizing the need for innovative approaches in this area.

Digital therapeutics are highlighted as a promising method to enhance the effectiveness and dissemination of incentive-based treatments, with opportunities for integration into pharmacotherapy trials and available funding for researchers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

National Institute on Drug Abuse (NIDA) research priorities to support the development of incentive-based treatments for substance use disorders. Aklin, WM., Herrmann, ES.[2023]

Patients with substance use disorders who used telehealth services via video in the first 14 days of treatment had a significantly lower risk of dropout compared to those receiving only in-person services, indicating that telehealth can enhance retention in treatment.

Early engagement in treatment was notably higher for patients using telehealth, both via video and telephone, compared to those receiving in-person care, suggesting that telehealth may improve initial treatment uptake for individuals seeking help.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Telehealth on Dropout and Retention in Care among Treatment-Seeking Individuals with Substance Use Disorder: A Retrospective Cohort Study. Gainer, DM., Wong, C., Embree, JA., et al.[2023]

In a study involving 270 participants undergoing an 8-week internet-delivered cognitive behavioral therapy (ICBT) program for alcohol misuse, significant reductions in alcohol consumption were observed, indicating the efficacy of ICBT itself (with large effect sizes).

However, adding a pre-treatment assessment interview or clinician guidance did not significantly enhance drinking outcomes, although guidance did improve adherence to the therapy modules.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing internet-delivered cognitive behaviour therapy for alcohol misuse-a randomized factorial trial examining effects of a pre-treatment assessment interview and guidance. Sundström, C., Peynenburg, V., Chadwick, C., et al.[2022]

The Automated Reinforcement Management System (ARMS) was tested with 12 participants with mild to moderate Alcohol Use Disorder (AUD) and showed high feasibility, with an average of 2.02 breathalyzer samples submitted daily and an 83.3% completion rate over 8 weeks.

Participants reported that the ARMS app was easy to use and helpful in reducing alcohol consumption, with 91.7% recommending it as a useful addition to traditional AUD treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated Reinforcement Management System: Feasibility study findings of an app-based contingency management treatment for alcohol use disorder. Miguel, AQ., Smith, CL., Rodin, NM., et al.[2023]

Telehealth-based contingency management (CM) for stimulant use disorder has shown preliminary feasibility and acceptability, allowing participants to successfully engage in treatment and verify abstinence through self-administered oral fluid testing.

Improvements are needed in the remote interpretation of toxicology test results to ensure accurate detection of abstinence, which is critical for delivering therapeutic incentives effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth-Based Contingency Management Targeting Stimulant Abstinence: A Case Series from the COVID-19 Pandemic. Forster, SE., Torres, TM., Steinhauer, SR., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06265506?cond=Alcohol&viewType=Table&rank=10

NCT06265506 | Virtual Incentive Treatment for Alcohol Seventy-one percent of CM participants achieved >4 weeks of abstinence versus 21% of the treatment as usual (TAU) group, and 43% of CM participants achieved >24 ...

2. reporter.nih.gov reporter.nih.gov/search/7_NkgDDx30aJw2vBLRmIrA/project-details/10929460

Project Details Seventy-one percent of CM participants achieved >4 weeks of abstinence versus 21% of the treatment as usual (TAU) group, and 43% of CM participants achieved >24 ...

3. trialx.com trialx.com/clinical-trials/listings/293393/virtual-incentive-treatment-for-alcohol/?&radius=10&place=All%20Participating%20Sites&user_country=Germany

Virtual Incentive Treatment for Alcohol Seventy-one percent of CM participants achieved >4 weeks of abstinence versus 21% of the treatment as usual (TAU) group, and 43% of CM ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1551714425000011

A randomized controlled trial to assess whether a ... A telehealth-based CM model that utilizes phosphatidylethanol (PEth) to confirm abstinence is effective at reducing alcohol use during a 26-week intervention ...

5. withpower.com withpower.com/trial/phase-alcohol-drinking-1-2024-174b5

Virtual Incentive Treatment for Alcoholism (VITA Trial) The overall objective of this program of research is to utilize phosphatidylethanol (PEth), a blood-based biomarker that can detect alcohol use for up to 28 ...

6. reporter.nih.gov reporter.nih.gov/project-details/11171603

Project Details - NIH RePORTER This intervention used a two-phase approach where the frequency of PEth testing and reinforcement was decreased from once a week, to as infrequently as every ...

7. trial.medpath.com trial.medpath.com/clinical-trial/36c7f70150f3691c/nct06265506-clinical-cost-effectiveness-virtual-PEth-AUD

Virtual Incentive Treatment for Alcohol | MedPath The overall objective of this study is to utilize phosphatidylethanol (PEth), a blood-based biomarker that can detect alcohol use for up to 28 days to deliver a ...