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Behavioural Intervention
CM Condition (Contingency Management + CBT4CBT) for Alcoholism (VITA Trial)
N/A
Waitlist Available
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every study visit, up to 18 months
Awards & highlights
VITA Trial 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.Check my eligibility
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.See study design
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.
VITA Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
Aim 1) Alcohol Abstinence: Regular excessive drinking
Other outcome measures
Additional Implementation Data: Attrition
Additional Implementation Data: CSQ-8
Adverse Events
+3 moreVITA 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
2003
Completed Phase 2
~3220
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center at San AntonioOTHER
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91,214 Total Patients Enrolled
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National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
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Weill Medical College of Cornell UniversityOTHER
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Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available vacancies for potential participants in this research study?
"As per clinicaltrials.gov, the current trial is not actively seeking participants. Originally posted on 2/19/2024 and last modified on 2/9/2024, this study has concluded its recruitment phase. However, there are numerous other opportunities available with 385 ongoing studies welcoming new participants at this time."
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