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Behavioural Intervention

Virtual Incentive Treatment for Alcoholism (VITA Trial)

N/A

Recruiting

Led By Sean Murphy, PhD

Research Sponsored by Washington State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Inability to provide informed consent based on the UBACC or MacCAT-CR

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every study visit, up to 18 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to use a blood test biomarker called phosphatidylethanol (PEth) to detect alcohol use for up to 28 days. The study will involve 200 adults with

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since the interventions involve computer-based training and contingency management rather than medication, traditional side effects are not expected. However, participants may experience stress or discomfort related to regular blood sample submissions.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am able to understand and agree to the study's requirements.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every study visit, up to 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every study visit, up to 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and every study visit, up to 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Aim 1) Alcohol Abstinence & Aim 3) Predictors: PEth-Defined Alcohol Abstinence During CM (Aim 1) and Follow-Up (Aim 3)

Aim 2) Alcohol Related Harms: Fagerstrom

Aim 2) Alcohol Related Harms: Perceived Stress Scale (PSS-10)

+14 more

Secondary study objectives

Aim 1) Alcohol Abstinence: Regular excessive drinking

Other study objectives

Additional Implementation Data: Attrition

Additional Implementation Data: CSQ-8

Adverse Events

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CM Condition (Contingency Management + CBT4CBT)Experimental Treatment2 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 Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Contingency Management

2014

Completed Phase 4

~3440

0 / 1Eligibility criteria met