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Enrolling by invitation NCT07451574

Acceptability and Feasibility Study of Non-alcoholic Beverages

No phase Interventional Alcohol Use Disorder (AUD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Non-alcoholic beer, Sparkling water.
Who it may be relevant to
Registry conditions: Alcohol Use Disorder (AUD). Basic parameters: 21 years — 89 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Non-alcoholic Beverages as a Therapeutic Adjunct in Alcohol Use Disorder Treatment: a Pilot Study of Acceptability and Feasibility

Overview

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

  • Other Non-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.
  • Other Sparkling 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.

Primary outcome measures

  • Participant Beverage Satisfaction (Acceptability) [Time frame: 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]
  • Participant Likelihood of Recommending Beverage (Acceptability) [Time frame: 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)]
  • Eligible Out of Screened (Feasibility) [Time frame: 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)]
  • Retention (Feasibility) [Time frame: 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]
Secondary outcome measures (8)
  • Average Blood Alcohol Content Across 6 Weeks [Time frame: Study weeks 1-6]
  • Change in Blood Alcohol Content Across 6 Weeks [Time frame: Treatment entry to week 6]
  • Average Number of Days with Breathalyzer Readings [Time frame: Assessed at 6 weeks.]
  • Median Number of Breathalyzer Readings Among Days with Readings [Time frame: Assessed at 6 weeks.]
  • Change in Reported Alcohol Use [Time frame: Baseline to 6 weeks.]
  • Perceived Change in Craving [Time frame: Assessed at 6 weeks.]
  • Perceived Change in Alcohol Use [Time frame: Assessed at 6 weeks.]
  • Perceived Impact of Beverages on Recovery [Time frame: Assessed at 6 weeks.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • Stanford Prevention Research Center — Stanford

Identifiers

NCT: NCT07451574 · 83997 · 1K99AA031716

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗