Recruiting

Virtual Incentive Treatment

Sponsor:

Washington State University

Code:

NCT06265506

Conditions

Alcohol Use Disorder

Alcohol Drinking

Alcohol Abuse

Alcohol Dependence

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Contingency Management

Computer Based Training for Cognitive Behavioral Therapy for AUD (CBT4CBT)

Study Details

Brief 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

Study ID

NCT06265506

Start date

Jun 18, 2024

Status verified date

May, 2025

Completion date

Apr 4, 2028

Anticipated

Primary completion date

Apr 3, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Control Condition (Non-contingent Incentives + CBT4CBT)

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.

experimental: CM Condition (Contingency Management + CBT4CBT)

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.

Interventions

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).

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.

Primary outcome measure

  • Aim 1) Alcohol Abstinence & Aim 3) Predictors: PEth-Defined Alcohol Abstinence During CM (Aim 1) and Follow-Up (Aim 3) [ Time Frame: Every study visit, up to 18 months ]
  • Aim 2) Alcohol-Related Harms: Addiction Severity Index (ASI) Lite [ Time Frame: Once a month during the intervention, Follow Up, up to 18 months ]
  • Aim 2) Alcohol-Related Harms: Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Once a month during the intervention, Follow Up, up to 18 months ]
  • Aim 2) Alcohol-Related Harms: Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: Once a month during the intervention, Follow Up, up to 18 months ]
  • Aim 2) Alcohol-Related Harms: Short Form Health Survey-12 (SF-12) [ Time Frame: 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 [ Time Frame: Once a month during the intervention, Follow Up, up to 18 months ]
  • Aim 2) Alcohol Related Harms: Fagerstrom [ Time Frame: Once a month during the intervention, Follow Up, up to 18 months ]
  • Aim 2) Alcohol Related Harms: Urine Drug Tests [ Time Frame: Every study visit, up to 18 months ]
  • Aim 2) Alcohol Related Harms: Perceived Stress Scale (PSS-10) [ Time Frame: Every study visit, up to 18 months ]
  • Aim 3) Predictors: Demographics [ Time Frame: Baseline ]
  • Aim 3) Predictors: Addictions Neuroclinical Assessment (ANA) Questionnaire [ Time Frame: Every study visit, up to 18 months ]
  • Aim 3) Predictors: TestMyBrain [ Time Frame: Baseline ]
  • Aim 3) Predictors: Positive Negative Affect Schedule (PANAS) [ Time Frame: Every study visit, up to 18 months ]
  • Aim 3) Predictors: Situational Confidence Questionnaire-8 (SCQ-8) [ Time Frame: Every study visit, up to 18 months ]
  • Aim 3) Predictors: Alcohol Craving VAS [ Time Frame: Every study visit, up to 18 months ]
  • Aim 4) Cost Analysis: Drug Abuse Treatment Cost Analysis Program (DATCAP) [ Time Frame: Baseline ]
  • Aim 4) Cost Analysis: PROPr [ Time Frame: Once a month during the intervention, Follow Up, up to 18 months ]

Central Contacts and Locations

Central contacts

Rachael M Beck, BS

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

Julianne Jett, PhD

509-368-6816julianne.jett@wsu.edu

Locations

Washington State University

Recruiting

Spokane, Washington, United States, 99201

Contacts

Michael McDonell, PhD

509-368-6967mmcdonell@wsu.edu

More Information

Sponsor

Washington State University

Last update posted

May 30, 2025

Last verified

May, 2025

Keywords

  • 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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Washington State University on 2025-05-30.