Alcohol Use DisorderVITANCT06265506
Virtual Incentive Treatment for Alcohol
A study testing Contingency Management and Computer Based Training for Cognitive Behavioral Therapy for AUD (CBT4CBT) in people with Alcohol Use Disorder and Alcohol Drinking, run by Washington State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder, Alcohol Drinking, Alcohol Abuse
- What is being tested?
- Contingency Management and Computer Based Training for Cognitive Behavioral Therapy for AUD (CBT4CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2024to 4 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- have a current diagnosis of severe substance use disorder (other than AUD, tobacco, and cannabis);
- PEth biomarker ≤ 20 ng/mL (indicates no heavy drinking in past month)
- inability to provide informed consent based on the UBACC or MacCAT-CR;
- alcohol withdrawal-related seizure or hospitalization in prior 12 months;
- psychiatrically or medically unsafe to participate, as assessed by the PI; and/or
- currently enrolled in alcohol treatment or another alcohol treatment study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington State University
Spokane, Washington, 99201
Michael McDonell, PhD, 509-368-6967, mmcdonell@wsu.edu
About this study
Official title: Assessing the Clinical and Cost-Effectiveness of a Virtual PEth-based Contingency Management for Adults With AUD
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.
Read the detailed description
The overall objective of this study 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. In a pilot trial, we developed a telehealth-based PEth CM intervention where participants used a medical device, the TASSO-M20 to self-collect blood for PEth testing under the observation of research staff over Zoom. This intervention used a two-phase approach where the frequency of PEth testing and reinforcement was decreased from once a week, to as infrequently as every four weeks once participants achieved a PEth level consistent with two to four weeks of abstinence (< 20 ng/mL). Seventy-one percent of CM participants achieved >4 weeks of abstinence versus 21% of the treatment as usual (TAU) group, and 43% of CM participants achieved >24 weeks of abstinence compared to 0% of the TAU group (p < 0.05). Based on these promising results, 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. The primary barrier to the dissemination of this model is the cost of PEth testing and CM reinforcers. Investigators will conduct an economic analysis to place these costs in the context of downstream CM-associated cost- offsets and improvements in personal and public health. If this model increases alcohol abstinence and is cost-effective it could reach millions of Americans with AUD that cannot or do not seek in-person care.
- Being tested
- Contingency Management, Computer Based Training for Cognitive Behavioral Therapy for AUD (CBT4CBT)
- 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
- Medical subject headings
- Alcoholism, Alcohol Drinking, Alcohol Abstinence, Anhedonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contingency ManagementBehavioural
Also called Motivational Incentives
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Condition (Non-contingent Incentives + CBT4CBT) | Active comparator | 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. Receives: Behavioral: Computer Based Training for Cognitive Behavioral Therapy for AUD (CBT4CBT) |
| CM Condition (Contingency Management + CBT4CBT) | Experimental | 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. Receives: Behavioral: Contingency Management; Behavioral: Computer Based Training for Cognitive Behavioral Therapy for AUD (CBT4CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aim 1) Alcohol Abstinence & Aim 3) Predictors: PEth-Defined Alcohol Abstinence During CM (Aim 1) and Follow-Up (Aim 3)
Investigators will use PEth 16:0/18:1, detectable from 8 to 5,000+ ng/mL via HPLC/MS/MS to assess the primary outcome. Abstinence from alcohol, the primary outcome, will be defined as a week-over-week PEth 16:0/18:1 reduction in Initiation Phase and PEth 16:0/18:1 < 20 ng/mL in Maintenance Phase. The primary Aim 3 outcome will be PEth-defined abstinence (PEth 16:0/18:1 < 20 ng/mL) during the 12-month follow-up.
Measured: Every study visit, up to 18 months
Aim 2) Alcohol-Related Harms: Addiction Severity Index (ASI) Lite
The ASI Lite will be used to assess the impact of alcohol use on psychiatric, legal, medical, and family functioning, as well as self-reported drug use.
Measured: Once a month during the intervention, Follow Up, up to 18 months
Aim 2) Alcohol-Related Harms: Patient Health Questionnaire-9 (PHQ-9)
Depression symptoms will be assessed with the PHQ-9. Scores range from 0-27. A score of 1-4 is consistent with minimal depression, a score of 5-9 is consistent with mild depression, a score of 10-14 is consistent with moderate depression, a score of 15 to 19 is consistent with moderately severe depression, and a score of 20-27 is consistent with severe depression. Lower depression scores are treated as a better outcome.
Measured: Once a month during the intervention, Follow Up, up to 18 months
Aim 2) Alcohol-Related Harms: Generalized Anxiety Disorder-7 (GAD-7)
Anxiety symptoms will be assessed using the GAD-7. A score of 0-4 is consistent with minimal anxiety, 5-9 with mild anxiety, 10-14 with moderate anxiety, and 15-21 with severe anxiety. A lower anxiety score is treated as a better outcome.
Measured: Once a month during the intervention, Follow Up, up to 18 months
Aim 2) Alcohol-Related Harms: Short Form Health Survey-12 (SF-12)
Physical health will be assessed using the SF-12. Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health. Higher scores will be considered a more positive outcome.
Measured: 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
Service utilization, employment, and education will be assessed by self-report using an NMOS form. Healthcare utilization will be assessed by self-reported, time-anchoring methods. Healthcare services will include non-study: inpatient, outpatient, emergency department; SUD medications; residential and outpatient SUD treatment days; hospital detoxification days; and mental health treatment visits. This information will be gathered for the 30 days prior to baseline, then "since the last assessment." Use of non-medical and other resources required for the economic evaluation from state-policymaker and societal perspectives (e.g., criminal-legal, safety-net utilization, labor productivity, travel time to medical care) will also be collected.
Measured: Once a month during the intervention, Follow Up, up to 18 months
Aim 2) Alcohol Related Harms: Fagerstrom
Nicotine use will be assessed using the Fagerstrom Test for Nicotine Dependence.
Measured: Once a month during the intervention, Follow Up, up to 18 months
Aim 2) Alcohol Related Harms: Urine Drug Tests
Point of care urine drug test immunoassay cups will be used to assess cocaine, amphetamine, methamphetamine, cannabis, and opioid use . Participants will collect urine in the privacy of their bathroom, and display the results of their urine drug test on camera to study staff. Results are binary positive/negative for each drug class.
Measured: Every study visit, up to 18 months
Aim 2) Alcohol Related Harms: Perceived Stress Scale (PSS-10)
Stress will be assessed with the 10-item PSS-10 to determine perceived stress. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress. Lower scores will be considered better outcomes.
Measured: Every study visit, up to 18 months
Aim 3) Predictors: Demographics
Demographics, such as age, sex assigned at birth, gender, race, ethnicity, education level, housing status, and income will be assessed of predictors of alcohol use outcomes.
Measured: Baseline
Aim 3) Predictors: Addictions Neuroclinical Assessment (ANA) Questionnaire
The ANA domains of executive functioning, negative affect, and incentive salience will be assessed via a 15-item questionnaire. Subdomains will be assessed as predictors of alcohol use outcomes.
Measured: Every study visit, up to 18 months
Aim 3) Predictors: TestMyBrain
Performance-base measures of executive functioning, including divided attention, working memory, mental flexibility, response inhibition, impulsivity, and delay discounting will be self-administered remotely using the TestMyBrain.org platform
Measured: Baseline
Aim 3) Predictors: Positive Negative Affect Schedule (PANAS)
Anhedonia will be measured with the 20-item PANAS. Positive Affect Score: Scores can range from 10 - 50, with higher scores representing higher levels of positive affect. Negative Affect Score: Scores can range from 10 - 50, with lower scores representing lower levels of negative affect. Scores will be assessed as predictors of alcohol use outcomes.
Measured: Every study visit, up to 18 months
Aim 3) Predictors: Situational Confidence Questionnaire-8 (SCQ-8)
Alcohol Craving will be measured with the 8-item SCQ-8. Each item, representing a "situation", is scored from 0 to 100. High scores (80 and above) indicate high confidence in being able to cope with craving. Low scores (0 to 20) indicate lower confidence in coping with craving and avoiding alcohol use. A global self-efficacy score can be calculated by taking the average of all of the situations. Scores will be assessed as predictors of alcohol use outcomes.
Measured: Every study visit, up to 18 months
Aim 3) Predictors: Alcohol Craving VAS
Alcohol Craving self-report over the past week and during the visit will be measured with a 1-100 Visual Analog Scale. A score of 0 is consistent with no alcohol craving, a score of 100 is consistent with the most alcohol craving. Scores will be assessed as predictors of alcohol use outcomes.
Measured: Every study visit, up to 18 months
Aim 4) Cost Analysis: Drug Abuse Treatment Cost Analysis Program (DATCAP)
Resources required to implement and sustain each intervention will be identified via microcosting analysis and the DATCAP, a standardized, customizable tool that captures intervention costs in a manner conducive to estimating costs across settings.
Measured: Baseline
Aim 4) Cost Analysis: PROPr
The Patient-Reported Outcomes Measurement Information System (PROMIS)-Preference (PROPr) measures a participant's health-related quality-of-life (HRQoL) across PROMIS domains of cognition, depression, anxiety, fatigue, pain interference, pain intensity, physical function, sleep disturbance, and ability to participate in social roles and activities. PROPr can generate a health utility index value, based on the participant's domain scores, that represents the US population's reference for the respondent's current health state. PROPr has five levels for each domain, ranging from "no" to "extreme" problems.
Measured: Once a month during the intervention, Follow Up, up to 18 months
Secondary outcomes (1)
Aim 1) Alcohol Abstinence: Regular excessive drinking
Defined as PEth 16:0/18:1 >=200 ng/mL.
Measured: Every study visit, up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start18 Jun 2024
- Primary completion3 Apr 2027 (estimated)
- Study completion4 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We will test the efficacy of our CM model against an evidence-based online intervention, CBT4CBT, by randomizing participants to six months of: 1. CBT4CBT and reinforcement for submitting blood samples (no requirement for abstinence) (Control Condition), or 2. CBT4CBT and reinforcement for PEth tests that are consistent with alcohol abstinence (CM Condition).
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington State University
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Texas Health Science Center at San Antonio, Weill Medical College of Cornell University, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Michael McDonell, Washington State University
- Investigators
- Michael McDonell, PhD, Principal investigator, Washington State University Elson S. Floyd College of MedicineNathalie Hill-Kapturczak, PhD, Principal investigator, University of Texas Health San AntonioSean Murphy, PhD, Principal investigator, Weill Cornell
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06265506
- Sponsor's protocol ID
- 20320
- Other IDs
- R01AA031013
- Acronym
- VITA
- Status last verified
- May 2025
- First submitted
- 11 Jan 2024
- Last updated
- 30 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified information will be shared through the NIAAA Data Archive. Data will be linked to a GUID and include surveys, interviews, and biological test results
Publications
Jett JD, Tyutyunnyk D, Beck R, Palmer K, Ryan D, Sanchez J, Weeks DL, McPherson SM, Chaytor N, Kiluk B, Javors MA, Ginsburg BC, Murphy S, Hill-Kapturczak N, McDonell MG. A randomized controlled trial to assess whether a telehealth-based contingency management intervention reduces alcohol use for individuals with alcohol use disorder. Contemp Clin Trials. 2025 Mar;150:107807. doi: 10.1016/j.cct.2025.107807. Epub 2025 Jan 15.
PubMed 39824379
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Clinical and Cost-Effectiveness of a Virtual PEth-based Contingency Management for Adults With AUD
- ClinicalTrials.gov ID
- NCT06265506
- Acronym / sponsor ID
- VITA / 20320
- Keywords
- Contingency Management, Alcohol Abstinence, Adult, Biological Markers, Blood, Clinical effectiveness, Cognitive Therapy, Blood collection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Washington State UniversityUniversity, hospital or other
- Collaborators
- The University of Texas Health Science Center at San Antonio, Weill Medical College of Cornell University, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 18 Jun 2024 (actual)
- Primary completion
- 3 Apr 2027 (estimated)
- Study completion
- 4 Apr 2028 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The overall objective of this study 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. In a pilot trial, we developed a telehealth-based PEth CM intervention where participants used a medical device, the TASSO-M20 to self-collect blood for PEth testing under the observation of research staff over Zoom. This intervention used a two-phase approach where the frequency of PEth testing and reinforcement was decreased from once a week, to as infrequently as every four weeks once participants achieved a PEth level consistent with two to four weeks of abstinence (< 20 ng/mL). Seventy-one percent of CM participants achieved >4 weeks of abstinence versus 21% of the treatment as usual (TAU) group, and 43% of CM participants achieved >24 weeks of abstinence compared to 0% of the TAU group (p < 0.05). Based on these promising results, 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. The primary barrier to the dissemination of this model is the cost of PEth testing and CM reinforcers. Investigators will conduct an economic analysis to place these costs in the context of downstream CM-associated cost- offsets and improvements in personal and public health. If this model increases alcohol abstinence and is cost-effective it could reach millions of Americans with AUD that cannot or do not seek in-person care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We will test the efficacy of our CM model against an evidence-based online intervention, CBT4CBT, by randomizing participants to six months of: 1. CBT4CBT and reinforcement for submitting blood samples (no requirement for abstinence) (Control Condition), or 2. CBT4CBT and reinforcement for PEth tests that are consistent with alcohol abstinence (CM Condition).
| Arm | Type | Receives |
|---|---|---|
| Control Condition (Non-contingent Incentives + CBT4CBT) | Active comparator | Behavioral: Computer Based Training for Cognitive Behavioral Therapy for AUD (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. |
| CM Condition (Contingency Management + CBT4CBT) | Experimental | Behavioral: Contingency Management, Behavioral: Computer Based Training for Cognitive Behavioral Therapy for AUD (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- have a current diagnosis of severe substance use disorder (other than AUD, tobacco, and cannabis);
- PEth biomarker ≤ 20 ng/mL (indicates no heavy drinking in past month)
- inability to provide informed consent based on the UBACC or MacCAT-CR;
- alcohol withdrawal-related seizure or hospitalization in prior 12 months;
- psychiatrically or medically unsafe to participate, as assessed by the PI; and/or
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contingency ManagementAlso: Motivational IncentivesContingency 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). | Behavioural | CM Condition (Contingency Management + CBT4CBT) |
| 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. | Behavioural | CM Condition (Contingency Management + CBT4CBT), Control Condition (Non-contingent Incentives + CBT4CBT) |
Primary outcome
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
Investigators will use PEth 16:0/18:1, detectable from 8 to 5,000+ ng/mL via HPLC/MS/MS to assess the primary outcome. Abstinence from alcohol, the primary outcome, will be defined as a week-over-week PEth 16:0/18:1 reduction in Initiation Phase and PEth 16:0/18:1 < 20 ng/mL in Maintenance Phase. The primary Aim 3 outcome will be PEth-defined abstinence (PEth 16:0/18:1 < 20 ng/mL) during the 12-month follow-up.
Aim 2) Alcohol-Related Harms: Addiction Severity Index (ASI) Lite
Time frame: Once a month during the intervention, Follow Up, up to 18 months
The ASI Lite will be used to assess the impact of alcohol use on psychiatric, legal, medical, and family functioning, as well as self-reported drug use.
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
Depression symptoms will be assessed with the PHQ-9. Scores range from 0-27. A score of 1-4 is consistent with minimal depression, a score of 5-9 is consistent with mild depression, a score of 10-14 is consistent with moderate depression, a score of 15 to 19 is consistent with moderately severe depression, and a score of 20-27 is consistent with severe depression. Lower depression scores are treated as a better outcome.
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
Anxiety symptoms will be assessed using the GAD-7. A score of 0-4 is consistent with minimal anxiety, 5-9 with mild anxiety, 10-14 with moderate anxiety, and 15-21 with severe anxiety. A lower anxiety score is treated as a better outcome.
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
Physical health will be assessed using the SF-12. Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health. Higher scores will be considered a more positive outcome.
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
Service utilization, employment, and education will be assessed by self-report using an NMOS form. Healthcare utilization will be assessed by self-reported, time-anchoring methods. Healthcare services will include non-study: inpatient, outpatient, emergency department; SUD medications; residential and outpatient SUD treatment days; hospital detoxification days; and mental health treatment visits. This information will be gathered for the 30 days prior to baseline, then "since the last assessment." Use of non-medical and other resources required for the economic evaluation from state-policymaker and societal perspectives (e.g., criminal-legal, safety-net utilization, labor productivity, travel time to medical care) will also be collected.
Aim 2) Alcohol Related Harms: Fagerstrom
Time frame: Once a month during the intervention, Follow Up, up to 18 months
Nicotine use will be assessed using the Fagerstrom Test for Nicotine Dependence.
Aim 2) Alcohol Related Harms: Urine Drug Tests
Time frame: Every study visit, up to 18 months
Point of care urine drug test immunoassay cups will be used to assess cocaine, amphetamine, methamphetamine, cannabis, and opioid use . Participants will collect urine in the privacy of their bathroom, and display the results of their urine drug test on camera to study staff. Results are binary positive/negative for each drug class.
Aim 2) Alcohol Related Harms: Perceived Stress Scale (PSS-10)
Time frame: Every study visit, up to 18 months
Stress will be assessed with the 10-item PSS-10 to determine perceived stress. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress. Lower scores will be considered better outcomes.
Aim 3) Predictors: Demographics
Time frame: Baseline
Demographics, such as age, sex assigned at birth, gender, race, ethnicity, education level, housing status, and income will be assessed of predictors of alcohol use outcomes.
Aim 3) Predictors: Addictions Neuroclinical Assessment (ANA) Questionnaire
Time frame: Every study visit, up to 18 months
The ANA domains of executive functioning, negative affect, and incentive salience will be assessed via a 15-item questionnaire. Subdomains will be assessed as predictors of alcohol use outcomes.
Aim 3) Predictors: TestMyBrain
Time frame: Baseline
Performance-base measures of executive functioning, including divided attention, working memory, mental flexibility, response inhibition, impulsivity, and delay discounting will be self-administered remotely using the TestMyBrain.org platform
Aim 3) Predictors: Positive Negative Affect Schedule (PANAS)
Time frame: Every study visit, up to 18 months
Anhedonia will be measured with the 20-item PANAS. Positive Affect Score: Scores can range from 10 - 50, with higher scores representing higher levels of positive affect. Negative Affect Score: Scores can range from 10 - 50, with lower scores representing lower levels of negative affect. Scores will be assessed as predictors of alcohol use outcomes.
Aim 3) Predictors: Situational Confidence Questionnaire-8 (SCQ-8)
Time frame: Every study visit, up to 18 months
Alcohol Craving will be measured with the 8-item SCQ-8. Each item, representing a "situation", is scored from 0 to 100. High scores (80 and above) indicate high confidence in being able to cope with craving. Low scores (0 to 20) indicate lower confidence in coping with craving and avoiding alcohol use. A global self-efficacy score can be calculated by taking the average of all of the situations. Scores will be assessed as predictors of alcohol use outcomes.
Aim 3) Predictors: Alcohol Craving VAS
Time frame: Every study visit, up to 18 months
Alcohol Craving self-report over the past week and during the visit will be measured with a 1-100 Visual Analog Scale. A score of 0 is consistent with no alcohol craving, a score of 100 is consistent with the most alcohol craving. Scores will be assessed as predictors of alcohol use outcomes.
Aim 4) Cost Analysis: Drug Abuse Treatment Cost Analysis Program (DATCAP)
Time frame: Baseline
Resources required to implement and sustain each intervention will be identified via microcosting analysis and the DATCAP, a standardized, customizable tool that captures intervention costs in a manner conducive to estimating costs across settings.
Aim 4) Cost Analysis: PROPr
Time frame: Once a month during the intervention, Follow Up, up to 18 months
The Patient-Reported Outcomes Measurement Information System (PROMIS)-Preference (PROPr) measures a participant's health-related quality-of-life (HRQoL) across PROMIS domains of cognition, depression, anxiety, fatigue, pain interference, pain intensity, physical function, sleep disturbance, and ability to participate in social roles and activities. PROPr can generate a health utility index value, based on the participant's domain scores, that represents the US population's reference for the respondent's current health state. PROPr has five levels for each domain, ranging from "no" to "extreme" problems.
1 secondary outcome
Aim 1) Alcohol Abstinence: Regular excessive drinking
Time frame: Every study visit, up to 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Derived from this study: PubMed 39824379Jett JD, Tyutyunnyk D, Beck R, Palmer K, Ryan D, Sanchez J, Weeks DL, McPherson SM, Chaytor N, Kiluk B, Javors MA, Ginsburg BC, Murphy S, Hill-Kapturczak N, McDonell MG. A randomized controlled trial to assess whether a telehealth-based contingency management intervention reduces alcohol use for individuals with alcohol use disorder. Contemp Clin Trials. 2025 Mar;150:107807. doi: 10.1016/j.cct.2025.107807. Epub 2025 Jan 15.
- Individual participant dataSharing planned: Yes. De-identified information will be shared through the NIAAA Data Archive. Data will be linked to a GUID and include surveys, interviews, and biological test results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contingency Management and Computer Based Training for Cognitive Behavioral Therapy for AUD (CBT4CBT) in people with Alcohol Use Disorder and Alcohol Drinking, run by Washington State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachael M Beck, BS (509-818-7024, prism.vitastudy@wsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06265506, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.