Virtual Incentive Treatment for Alcohol (VITA)

May 23, 2025 updated by: Michael McDonell, Washington State University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Washington
      • Spokane, Washington, United States, 99201
        • Recruiting
        • Washington State University
        • Contact:

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: 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.
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.
Behavioral: 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.
Behavioral: 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).
Other Names:
  • Motivational Incentives

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
Nicotine use will be assessed using the Fagerstrom Test for Nicotine Dependence.
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
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.
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
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.
Every study visit, up to 18 months
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.
Baseline
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.
Every study visit, up to 18 months
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
Baseline
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.
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
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.
Every study visit, up to 18 months
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.
Every study visit, up to 18 months
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.
Baseline
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.
Once a month during the intervention, Follow Up, up to 18 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Aim 1) Alcohol Abstinence: Regular excessive drinking
Time Frame: Every study visit, up to 18 months
Defined as PEth 16:0/18:1 >=200 ng/mL.
Every study visit, up to 18 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Aim 1) Alcohol Abstinence: uEtG-Defined Alcohol Abstinence
Time Frame: Every study visit, up to 18 months
Urine samples will be tested for uEtG at each visit using uEtG dipcards with a threshold of 300 ng/mL
Every study visit, up to 18 months
Aim 1) Alcohol Abstinence: Self-reported Alcohol Abstinence and Heavy Drinking
Time Frame: Every study visit, up to 18 months
Assessed by the Alcohol Timeline Follow Back (TLFB)
Every study visit, up to 18 months
Additional Implementation Data: Attrition
Time Frame: Every study visit, up to 18 months
We will record attrition, defined as one month of no contact with the study team, and track attendance at study appointments.
Every study visit, up to 18 months
Additional Implementation Data: CSQ-8
Time Frame: Weeks 4 & 26
To assess participant satisfaction, we will administer the 8-item Client Satisfaction Questionnaire (CSQ-8) at weeks four and 26, with a mean score of > 23 indicating overall satisfaction.
Weeks 4 & 26
Adverse Events
Time Frame: Every study visit, up to 18 months
Risks related to suicidality, dangerous alcohol use, and withdrawal symptoms will be recorded. Withdrawal symptoms will be assessed at every visit using the Sweating, Hallucinations, Orientation, Tremor (SHOT) scale, with adaptations for virtual observation and evaluation. Time spent in inpatient mental and physical health care, incarceration, visits to residential treatment programs, and other controlled environments will be recorded. Symptoms of suicidal risk will be assessed at monthly and follow-up visits.
Every study visit, up to 18 months
Computer Based Training for Cognitive Behavioral Health (CBT4CBT) Program Use
Time Frame: Treatment & Follow up, up to 18 months
Completion of CBT4CBT modules, scores on practice quizzes, and participant reported use of CBT4CBT skills will be recorded.
Treatment & Follow up, up to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Washington State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Weill Medical College of Cornell University
The University of Texas Health Science Center at San Antonio

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael McDonell, PhD, Washington State University Elson S. Floyd College of Medicine
  • Principal Investigator: Nathalie Hill-Kapturczak, PhD, University of Texas Health San Antonio
  • Principal Investigator: Sean Murphy, PhD, 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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 18, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 3, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 4, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 11, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20320
  • R01AA031013 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

Data uploads to the archive will begin April 1 2024

IPD Sharing Access Criteria

Account with the NIAAA Data Archive

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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