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

Trial Summary

What is the purpose of this 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 days to deliver a feasible telehealth-based 26-week CM intervention. This study will test a telehealth PEth-based CM model in a sample of adults with AUD (n=200), recruited via online platforms by randomizing individuals to six months of 1) an online cognitive behavioral therapy for AUD (CBT4CBT) and telehealth PEth-based CM (CM condition) or 2) CBT4CBT and reinforcers for submitting blood samples (no abstinence required) (control condition). Investigators will assess group differences in PEth-defined abstinence and regular excessive drinking (PEth \>= 200 ng/mL), and alcohol-related harms (e.g., smoking, drug use). This study will address important gaps in CM research by assessing outcomes during a 12-month follow-up, which is much longer than most previous CM studies; using a conceptual model to identify predictors of post-treatment abstinence. Investigators will conduct an economic analysis to place the cost of this model in the context of downstream CM-associated cost-offsets and improvements in personal and public health.

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.

What data supports the effectiveness of the Virtual Incentive Treatment for Alcoholism?

Research shows that computer-based interventions, like the Virtual Incentive Treatment, can be effective for substance use disorders by increasing motivation to change and reducing substance use. Additionally, online therapy programs have been found useful for individuals with alcohol problems, especially those motivated to change their drinking habits. ^{1 2 3 4 5}

Is Virtual Incentive Treatment for Alcoholism safe for humans?

The studies reviewed focus on telehealth and automated systems for treating substance use disorders, including alcohol use disorder, and suggest these methods are generally well-accepted and feasible. However, specific safety data for Virtual Incentive Treatment itself is not provided. ^{1 6 7 8 9}

How is Virtual Incentive Treatment for Alcoholism different from other treatments?

Virtual Incentive Treatment for Alcoholism is unique because it combines digital incentives with telehealth and cognitive behavioral therapy (CBT) to encourage sobriety, using a biomarker (PEth) to monitor alcohol use. This approach leverages technology to provide accessible, personalized support and motivation, which can be more engaging and convenient than traditional face-to-face therapy. ^{1 2 3 5 10}

Research Team

Michael McDonell, PhD

Principal Investigator

Washington State University Elson S. Floyd College of Medicine

Nathalie Hill-Kapturczak, PhD

Principal Investigator

University of Texas Health San Antonio

Sean Murphy, PhD

Principal Investigator

Weill Cornell

Eligibility Criteria

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

Had 2 heavy drinking episodes (assigned male at birth > 4 standard drinks (SDs), assigned female at birth > 3 SDs) or ≥14 SDs in the prior 14 days verified by PEth 16:0/18:1 biomarker > 20 ng/mL (indicates at least 2 heavy drinking episodes in past two weeks)

Have a DSM-5 diagnosis of a current AUD as assessed by the Structured Clinical Interview for DSM-5

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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

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

2. United States 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. [2023]

3. Canada 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. [2023]

4. Australia pubmed.ncbi.nlm.nih.gov

Feasibility and preliminary effectiveness of internet-mediated 'relapse prevention therapy' for patients with alcohol use disorder: A pilot study. [2022]

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

Computer-based interventions for drug use disorders: a systematic review. [2022]

6. England 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. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Automated Reinforcement Management System: Feasibility study findings of an app-based contingency management treatment for alcohol use disorder. [2023]

8. England 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. [2022]

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

Telehealth-Based Contingency Management Targeting Stimulant Abstinence: A Case Series from the COVID-19 Pandemic. [2023]

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

Mobile Delivery of Treatment for Alcohol Use Disorders: A Review of the Literature. [2022]