RecruitingNot Applicable

Virtual Incentive Treatment for Alcohol

United States200 participantsStarted 2024-06-18

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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;
. 18+ (individuals over 65 will be assessed for cognitive impairments)
. Are not receiving treatment for AUD
. Are able to complete virtual study visits via Zoom

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Every study visit, up to 18 months

Aim 2) Alcohol-Related Harms: Addiction Severity Index (ASI) Lite

Timeframe: Once a month during the intervention, Follow Up, up to 18 months

Aim 2) Alcohol-Related Harms: Patient Health Questionnaire-9 (PHQ-9)

Timeframe: Once a month during the intervention, Follow Up, up to 18 months

Aim 2) Alcohol-Related Harms: Generalized Anxiety Disorder-7 (GAD-7)

Timeframe: Once a month during the intervention, Follow Up, up to 18 months

Aim 2) Alcohol-Related Harms: Short Form Health Survey-12 (SF-12)

Timeframe: Once a month during the intervention, Follow Up, up to 18 months

Aim 2) Alcohol-Related Harms & Aim 4) Cost Analysis: Non-study Medical and Other Services (NMOS) form

Timeframe: Once a month during the intervention, Follow Up, up to 18 months

Trial details

NCT IDNCT06265506

SponsorWashington State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-04-03

Contact for this trial

Rachael M Beck, BS

509-818-7024 prism.vitastudy@wsu.edu

View on ClinicalTrials.gov More Alcohol Use Disorder trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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;
. 18+ (individuals over 65 will be assessed for cognitive impairments)
. Are not receiving treatment for AUD
. Are able to complete virtual study visits via Zoom