RECRUITING

Virtual Incentive Treatment for Alcohol

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Assessing the Clinical and Cost-Effectiveness of a Virtual PEth-based Contingency Management for Adults With AUD

Quick Facts

Study Start:2024-06-18
Study Completion:2028-04-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06265506

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. Have a DSM-5 diagnosis of a current AUD as assessed by the Structured Clinical Interview for DSM-5;
  3. 3. 18+ (individuals over 65 will be assessed for cognitive impairments)
  4. 4. Are not receiving treatment for AUD
  5. 5. Are able to complete virtual study visits via Zoom
  1. 1. have a current diagnosis of severe substance use disorder (other than AUD, tobacco, and cannabis);
  2. 2. PEth biomarker ≤ 20 ng/mL (indicates no heavy drinking in past month)
  3. 3. inability to provide informed consent based on the UBACC or MacCAT-CR;
  4. 4. alcohol withdrawal-related seizure or hospitalization in prior 12 months;
  5. 5. psychiatrically or medically unsafe to participate, as assessed by the PI; and/or
  6. 6. currently enrolled in alcohol treatment or another alcohol treatment study.

Contacts and Locations

Study Contact

Rachael M Beck, BS
CONTACT
509-818-7024
prism.vitastudy@wsu.edu
Julianne Jett, PhD
CONTACT
509-368-6816
julianne.jett@wsu.edu

Principal Investigator

Michael McDonell, PhD
PRINCIPAL_INVESTIGATOR
Washington State University Elson S. Floyd College of Medicine
Nathalie Hill-Kapturczak, PhD
PRINCIPAL_INVESTIGATOR
University of Texas Health San Antonio
Sean Murphy, PhD
PRINCIPAL_INVESTIGATOR
Weill Cornell

Study Locations (Sites)

Washington State University
Spokane, Washington, 99201
United States

Collaborators and Investigators

Sponsor: Washington State University

  • Michael McDonell, PhD, PRINCIPAL_INVESTIGATOR, Washington State University Elson S. Floyd College of Medicine
  • Nathalie Hill-Kapturczak, PhD, PRINCIPAL_INVESTIGATOR, University of Texas Health San Antonio
  • Sean Murphy, PhD, PRINCIPAL_INVESTIGATOR, Weill Cornell

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-18
Study Completion Date2028-04-04

Study Record Updates

Study Start Date2024-06-18
Study Completion Date2028-04-04

Terms related to this study

Keywords Provided by Researchers

  • Contingency Management
  • Alcohol Abstinence
  • Adult
  • Biological Markers
  • Blood
  • Clinical effectiveness
  • Cognitive Therapy
  • Blood collection
  • Ethyl glucuronide
  • Health Care Costs
  • Heavy Drinking
  • Addictions Neuroclinical Assessment
  • Cognition
  • Incentives
  • Phosphatidylethanol
  • Incentive salience
  • Anhedonia
  • Longitudinal Studies
  • Prediction of Response to Therapy
  • Randomized Clinical Trial
  • Telehealth
  • Virtual Health
  • Video conference

Additional Relevant MeSH Terms

  • Alcohol Use Disorder
  • Alcohol Drinking
  • Alcohol Abuse
  • Alcohol Dependence