Telehealth program using blood tests to help treat alcohol use disorder
Assessing the Clinical and Cost-Effectiveness of a Virtual PEth-based Contingency Management for Adults With AUD
This study is testing a new telehealth program that uses blood tests to help people with alcohol use disorder by combining online therapy with rewards for submitting their test results.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Washington State University Academic / other |
| Locations | 1 site (Spokane, Washington) |
| Trial ID | NCT06265506 on ClinicalTrials.gov |
What this trial studies
This program aims to evaluate a telehealth-based intervention that utilizes phosphatidylethanol (PEth), a biomarker for alcohol use, to deliver a contingency management (CM) approach over 26 weeks. Participants will be randomly assigned to either receive online cognitive behavioral therapy combined with PEth-based CM or therapy with incentives for submitting blood samples without requiring abstinence. The study will assess differences in alcohol abstinence and excessive drinking over a 12-month follow-up period. This innovative approach addresses gaps in existing CM research by utilizing a longer follow-up and a conceptual model to identify predictors of treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a current diagnosis of alcohol use disorder who have experienced heavy drinking episodes.
Not a fit: Patients with severe substance use disorders other than alcohol or those who have not engaged in heavy drinking recently may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve abstinence rates and reduce alcohol-related harms for individuals with alcohol use disorder.
How similar studies have performed: Previous pilot trials have shown promising results with similar contingency management approaches, indicating potential for success in this study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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); 2. Have a DSM-5 diagnosis of a current AUD as assessed by the Structured Clinical Interview for DSM-5; 3. 18+ (individuals over 65 will be assessed for cognitive impairments) 4. Are not receiving treatment for AUD 5. Are able to complete virtual study visits via Zoom Exclusion Criteria: 1. have a current diagnosis of severe substance use disorder (other than AUD, tobacco, and cannabis); 2. PEth biomarker ≤ 20 ng/mL (indicates no heavy drinking in past month) 3. inability to provide informed consent based on the UBACC or MacCAT-CR; 4. alcohol withdrawal-related seizure or hospitalization in prior 12 months; 5. psychiatrically or medically unsafe to participate, as assessed by the PI; and/or 6. currently enrolled in alcohol treatment or another alcohol treatment study.
Where this trial is running
Spokane, Washington
- Washington State University — Spokane, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Michael McDonell, PhD — Washington State University Elson S. Floyd College of Medicine
- Study coordinator: Rachael M Beck, BS
- Email: prism.vitastudy@wsu.edu
- Phone: 509-818-7024
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.