Virtual Incentive Treatment for Alcohol
NCT06265506 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2025-05-30
Summary
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.
Conditions
- Alcohol Use Disorder
- Alcohol Drinking
- Alcohol Abuse
- Alcohol Dependence
Interventions
- BEHAVIORAL
-
Contingency Management
Contingency Management (CM) is an intervention that uses positive reinforcement (e.g. gift cards) to reinforce a desired behavior (e.g. negative alcohol biomarker tests) on a frequent (e.g. weekly), escalating (e.g. $5/week) schedule (e.g. 26 weeks) in order to increase the occurrence of that behavior (e.g. long term alcohol abstinence or reduction in drinking).
- BEHAVIORAL
-
Computer Based Training for Cognitive Behavioral Therapy for AUD (CBT4CBT)
CBT4CBT is an evidence-based online intervention that teaches CBT principles and skills to help people with alcohol use disorder reduce their drinking. CBT4CBT teaches CBT principles through video, graphics, audio instruction, and interactive exercises. Modules include video-based examples to emphasize learning of behavioral, cognitive, and affective strategies, with an emphasis on learning from examples of individuals using skills in a range of situations. Skills taught include functional analysis, coping with craving and emotions, problem solving, decision making, challenging thoughts, and assertive alcohol refusal. Interactive exercises and homework are used to encourage skills learning and practice.
Sponsors & Collaborators
-
The University of Texas Health Science Center at San Antonio
collaborator OTHER -
Weill Medical College of Cornell University
collaborator OTHER -
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
collaborator NIH -
Washington State University
lead OTHER
Principal Investigators
-
Michael McDonell, PhD · Washington State University Elson S. Floyd College of Medicine
-
Nathalie Hill-Kapturczak, PhD · University of Texas Health San Antonio
-
Sean Murphy, PhD · Weill Cornell
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-06-18
- Primary Completion
- 2027-04-03
- Completion
- 2028-04-04
Countries
- United States
Study Locations
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