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| ID | Type | Description | Link |
|---|---|---|---|
| 1K99AA031716 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-alcoholic beer | Experimental | Participants will receive non-alcoholic beers (volume matching alcohol volume intake prior to alcohol use disorder treatment enrollment) for 6 weeks. |
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| Sparkling water | Other | Participants will receive sparkling water (volume matching alcohol volume intake prior to alcohol use disorder treatment enrollment) for 6 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-alcoholic beer | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Beverage Satisfaction (Acceptability) | "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) | "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) | "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) | 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) | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Average Blood Alcohol Content Across 6 Weeks | 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 |
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Inclusion Criteria:
Participants will be eligible if they report on the screening survey:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Molly A Bowdring, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Prevention Research Center | Stanford | California | 94304 | United States |
Data will be uploaded to the NIAAA data archive
Analytic code, data, and data dictionary will be uploaded upon at the time of primary results submission to an academic journal.
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D061545 | Carbonated Water |
| ID | Term |
|---|---|
| D008900 | Mineral Waters |
| D014867 | Water |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 |
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| Sparkling water | Other | 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. |
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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) | 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) | 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 |
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 | 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 | Median number of breathalyzer readings among days with readings across the 6-week study. | Assessed at 6 weeks. |
| Change in Reported Alcohol Use | 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 | 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 | 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 | 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. |
| Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D002253 | Carbonated Beverages |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D060766 | Drinking Water |
| D019602 | Food and Beverages |