Alcohol Use Disorder (AUD)
Conditions
Keywords
non-alcoholic beer, alcohol
Brief summary
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.
Interventions
OTHERNon-alcoholic beer
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.
OTHERSparkling water
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.
Sponsors
Stanford University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 89 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant Beverage Satisfaction (Acceptability) | 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. |
| Participant Intention to Consume Assigned Beverage in the Future (Acceptability) | 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. |
| Participant Likelihood of Recommending Beverage (Acceptability) | 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. |
| Screened Out of Contacted (Feasibility) | 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. |
| Eligible Out of Screened (Feasibility) | 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. |
| Enrolled Out of Eligible (Feasibility) | 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. |
| Retention (Feasibility) | 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. |
| Perception of Beverage Supply (Feasibility) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Blood Alcohol Content Across 6 Weeks | Study weeks 1-6 | Average blood alcohol content (measured via breathalyzer) across the 6-week period split by condition. |
| Change in Blood Alcohol Content Across 6 Weeks | 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 \[split by condition\]. |
| Average Number of Days with Breathalyzer Readings | Assessed at 6 weeks. | Average number of days with breathalyzer readings across the 6-week study. |
| Median Number of Breathalyzer Readings Among Days with Readings | Assessed at 6 weeks. | Median number of breathalyzer readings among days with readings across the 6-week study. |
| Change in Reported Alcohol Use | 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 \[split by condition\]. |
| Perceived Change in Craving | 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. |
| Perceived Change in Alcohol Use | 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." |
| Perceived Impact of Beverages on Recovery | 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 \[split by condition\]. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMolly A Bowdring, PhD
Stanford University
Outcome results
None listed