- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07451574
Acceptability and Feasibility Study of Non-alcoholic Beverages
May 27, 2026 updated by: Molly Anne Bowdring, Stanford University
Non-alcoholic Beverages as a Therapeutic Adjunct in Alcohol Use Disorder Treatment: a Pilot Study of Acceptability and Feasibility
This project will elucidate the acceptability and feasibility of incorporating provision of non-alcoholic beers into alcohol use disorder treatment, for patients interested in using non-alcoholic beers as part of their recovery from alcohol use disorder.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- 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 Locations
-
-
California
-
Stanford, California, United States, 94304
- Stanford Prevention Research Center
-
-
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
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
Participants will be eligible if they report on the screening survey:
- living in California and provide a California mailing address (to ship study materials to)
- consuming ≤42 alcoholic beverages per week (as we seek to provide an equal count of the substitute beverage and budgetary restrictions prevent an amount greater than that)
- having alcohol use disorder documented with ≥2 symptoms on the Alcohol Symptom Checklist
- being enrolled in Ria Health treatment
- having English language fluency
Exclusion Criteria:
- Individuals will be excluded at the online screener survey stage if they do not meet all of the inclusion criteria.
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: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Non-alcoholic beer
Participants will receive non-alcoholic beers (volume matching alcohol volume intake prior to alcohol use disorder treatment enrollment) for 6 weeks.
|
Participants will receive non-alcoholic beers and will be encouraged to consume the beverages to the extent they find useful/desirable during the 6-week study period.
|
|
Other: Sparkling water
Participants will receive sparkling water (volume matching alcohol volume intake prior to alcohol use disorder treatment enrollment) for 6 weeks.
|
Participants will receive sparkling water and will be encouraged to consume the beverages to the extent they find useful/desirable during the 6-week study period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participant Beverage Satisfaction (Acceptability)
Time Frame: Assessed at the end of week 6
|
"How satisfied were you with the beverages you received in this study?"
with 5-pt scale response options ranging from "Very Unsatisfied" to "Very Satisfied."
Higher scores [split by condition] will indicate greater acceptability.
|
Assessed at the end of week 6
|
|
Participant Intention to Consume Assigned Beverage in the Future (Acceptability)
Time Frame: Assessed at the end of week 6
|
"Do you intend to consume the beverage type you received in the future?" with 5-pt scale response options ranging from "Definitely not" to "Definitely."
Higher scores [split by condition] will indicate greater acceptability.
|
Assessed at the end of week 6
|
|
Participant Likelihood of Recommending Beverage (Acceptability)
Time Frame: Assessed at the end of week 6
|
"Would you recommend the use of the beverage type you received for people who have alcohol use disorder?"
with 5-pt scale response options ranging from "Definitely not" to "Definitely."
Higher scores [split by condition] will indicate greater acceptability.
|
Assessed at the end of week 6
|
|
Screened Out of Contacted (Feasibility)
Time Frame: Beginning of recruitment to end of recruitment (approximately 3-6 months)
|
Percentage of participants who completed the screening measure out of those who were contacted.
Higher percentage will indicate greater feasibility.
|
Beginning of recruitment to end of recruitment (approximately 3-6 months)
|
|
Eligible Out of Screened (Feasibility)
Time Frame: Beginning of recruitment to end of recruitment (approximately 3-6 months)
|
Percentage of participants who screen eligible out of those who were screened.
Higher percentage will indicate greater feasibility.
|
Beginning of recruitment to end of recruitment (approximately 3-6 months)
|
|
Enrolled Out of Eligible (Feasibility)
Time Frame: Beginning of recruitment to end of recruitment (approximately 3-6 months)
|
Percentage of participants who enrolled out of those who screened eligible.
Higher percentage will indicate greater feasibility.
|
Beginning of recruitment to end of recruitment (approximately 3-6 months)
|
|
Retention (Feasibility)
Time Frame: Beginning of recruitment to end of data collection (approximately 3-6 months)
|
Percentage of participants who completed the study out of those who enrolled.
Higher percentage [split by condition] will indicate greater feasibility.
|
Beginning of recruitment to end of data collection (approximately 3-6 months)
|
|
Perception of Beverage Supply (Feasibility)
Time Frame: Assessed at the end of week 6
|
Percentage of participants whose response to "How was the supply of beverages you received throughout the study?" is "just right" [as opposed to "too little" or "too much"].
Higher percentage [split by condition] will indicate greater feasibility.
|
Assessed at the end of week 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Average Blood Alcohol Content Across 6 Weeks
Time Frame: Study weeks 1-6
|
Average blood alcohol content (measured via breathalyzer) across the 6-week period split by condition.
|
Study weeks 1-6
|
|
Change in Blood Alcohol Content Across 6 Weeks
Time Frame: Treatment entry to week 6
|
Slopes of blood alcohol content separated by condition for: a) start of treatment to pre-study and b) during the 6-week study period [split by condition].
|
Treatment entry to week 6
|
|
Average Number of Days with Breathalyzer Readings
Time Frame: Assessed at 6 weeks.
|
Average number of days with breathalyzer readings across the 6-week study.
|
Assessed at 6 weeks.
|
|
Median Number of Breathalyzer Readings Among Days with Readings
Time Frame: Assessed at 6 weeks.
|
Median number of breathalyzer readings among days with readings across the 6-week study.
|
Assessed at 6 weeks.
|
|
Change in Reported Alcohol Use
Time Frame: Baseline to 6 weeks.
|
Percentage of participants endorsing use of study-provided beverages who experienced (a) increase in alcohol use (defined as change in average use per week pre-study to average use per week across the study), (b) no change in alcohol use, (c) decrease in alcohol use [split by condition].
|
Baseline to 6 weeks.
|
|
Perceived Change in Craving
Time Frame: Assessed at 6 weeks.
|
Percentage of participants endorsing use of study-provided beverages who reported (a) increased in desire to drink alcohol, (b) no change in desire to drink alcohol, (c) decreased desire to drink alcohol [split by condition] in response to the item "When I drink the study provided beverages I experience…Less desire to drink alcohol; No change in my desire to drink alcohol; or More desire to drink alcohol.
|
Assessed at 6 weeks.
|
|
Perceived Change in Alcohol Use
Time Frame: Assessed at 6 weeks.
|
Percentage of participants endorsing use of study-provided beverages who reported (a) increased in alcohol use, (b) no change in alcohol use, (c) increased alcohol use [split by condition] in response to the item "Because I drink the study provided beverages I drink...Less alcohol than I otherwise would; The same amount of alcohol that I otherwise would; or More alcohol than I otherwise would."
|
Assessed at 6 weeks.
|
|
Perceived Impact of Beverages on Recovery
Time Frame: Assessed at 6 weeks.
|
Percentage of participants who responded to the item "What impact did the study provided beverages have on your recovery from alcohol use disorder?"
with (a) Harmful; (b) No impact; or (c) Helpful [split by condition].
|
Assessed at 6 weeks.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Molly A Bowdring, PhD, Stanford University
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)
May 14, 2026
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 1, 2026
Study Registration Dates
First Submitted
February 27, 2026
First Submitted That Met QC Criteria
February 27, 2026
First Posted (Actual)
March 5, 2026
Study Record Updates
Last Update Posted (Actual)
May 29, 2026
Last Update Submitted That Met QC Criteria
May 27, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Substance-Related Disorders
- Chemically-Induced Disorders
- Alcohol-Related Disorders
- Alcoholism
- Diet, Food, and Nutrition
- Physiological Phenomena
- Food and Beverages
- Inorganic Chemicals
- Beverages
- Anions
- Ions
- Electrolytes
- Hydroxides
- Alkalies
- Oxides
- Oxygen Compounds
- Water
- Mineral Waters
- Carbonated Beverages
- Drinking Water
- Carbonated Water
Other Study ID Numbers
- 83997
- 1K99AA031716 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Data will be uploaded to the NIAAA data archive
IPD Sharing Time Frame
Analytic code, data, and data dictionary will be uploaded upon at the time of primary results submission to an academic journal.
IPD Sharing Supporting Information Type
- ANALYTIC_CODE
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.
Clinical Trials on Alcohol Use Disorder (AUD)
-
University of Wisconsin, MadisonNational Institute on Alcohol Abuse and Alcoholism (NIAAA)RecruitingAlcohol Use Disorder | Alcohol Use Disorder (AUD)United States
-
Washington State UniversityRecruitingNicotine Use Disorder | Alcohol Use Disorder (AUD)United States
-
University of BernRecruitingAlcohol Use Disorder (AUD) | Substance Use Disorder (SUD) | Cocaine Use Disorder (CUD)Switzerland
-
Washington State UniversityNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Not yet recruiting
-
Felix MuellerUniversity of BernRecruiting
-
Brown UniversityRecruiting
-
University of PennsylvaniaActive, not recruitingAlcoholism | Alcohol Use Disorder (AUD)United States
-
Tempero Bio, Inc.TerminatedAlcohol Use Disorder (AUD)United States
-
Boston Medical CenterNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Completed
-
Brigham and Women's HospitalRecruitingAlcohol Use Disorder (AUD)United States
Clinical Trials on Non-alcoholic beer
-
Instituto Nacional de Ciencias Medicas y Nutricion...CompletedQuality of Life | Nutritional Status | Endothelial Dysfunction
-
Universidade do PortoNOVA Medical School; Center for Health Technology and Services ResearchUnknownDiabetes Mellitus, Type 2Portugal
-
David FaehNot yet recruitingGlycemic Index | Dietary Fiber | Blood Glucose Concentration | Non-alcoholic Beer
-
State University of New York - Upstate Medical...Completed
-
University Hospital, Basel, SwitzerlandCompleted
-
Technical University of MunichCompletedHeart Failure | Inflammation | Sudden Cardiac DeathGermany
-
Balgrist University HospitalCompletedFood SensitivitySwitzerland
-
Central Institute of Mental Health, MannheimCompletedHeavy DrinkingGermany
-
Universidade do PortoUniversidade Nova de LisboaCompletedHealthy VolunteersPortugal
-
NestléCompletedAcute Response to Food Ingredient ConsumptionSwitzerland