Virtual Incentive Treatment for Alcohol Use Disorder
This study is testing a new way to help people with Alcohol Use Disorder (AUD) reduce their drinking. It combines an online program called Computer Based Training for Cognitive Behavioral Therapy for AUD (CBT4CBT) with a system called Contingency Management (CM). CM uses positive reinforcement, like gift cards, for desired behaviors such as negative alcohol biomarker tests. You might be eligible if you are 18 or older, have been diagnosed with AUD, and have had specific heavy drinking episodes recently, confirmed by a blood test (PEth biomarker). The study aims to see if this approach helps people achieve alcohol abstinence and reduces alcohol-related harms. The current recruitment status is unclear, and the study plans to enroll 200 participants.
- Study design
- This interventional study plans to enroll 200 participants. Individuals will be randomly assigned to one of two groups for six months: either CBT4CBT with telehealth PEth-based CM, or CBT4CBT with reinforcers for submitting blood samples (no abstinence required).
- What's involved
- Participants will have study visits, including blood tests (PEth biomarker) to check for alcohol use, and complete questionnaires like the Addiction Severity Index (ASI) Lite and Patient Health Questionnaire-9 (PHQ-9) monthly during the intervention and follow-up.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 18 months after the intervention period to assess alcohol abstinence and alcohol-related harms.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Virtual Incentive Treatment for Alcohol
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- 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
Who to contact
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What this trial measures
- Aim 1) Alcohol Abstinence & Aim 3) Predictors: PEth-Defined Alcohol Abstinence During CM (Aim 1) and Follow-Up (Aim 3)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) LiteOnce 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)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)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)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) formOnce 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: FagerstromOnce 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 TestsEvery 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)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: DemographicsBaseline
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) QuestionnaireEvery 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: TestMyBrainBaseline
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)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)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 VASEvery 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)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: PROPrOnce 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.