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NCT05373706: Project ACE

Testing Brief Personalized Feedback Integrating EMA Alcohol Cue Information

Completed NA Results posted Last updated 4 June 2024
What this trial tests

NA trial testing Alcohol Cue Reactivity Personalized Feedback Intervention in Alcohol Drinking in 99 participants. Completed in 1 May 2023.

Timeline
29 April 2022
Primary endpoint
1 May 2023
1 May 2023

Quick facts

Lead sponsorUniversity of Washington
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment99
Start date29 April 2022
Primary completion1 May 2023
Estimated completion1 May 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Washington

Who can join

Adults 18 to 24, any sex, with Alcohol Drinking or Problem Drinking. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Daily Drinking Questionnaire Primary · Baseline, 2 week follow-up, and 3 month follow-up

Number of standard drinks consumed on each day of a typical week during the \[past 3 months for baseline and 3-month follow-up; past two weeks for 2-week follow-up\]. Participants responded on a scale from 0 (0 drinks) to 25 (25 or more drinks). Totals for each day are summed to calculate the typical number of drinks consumed per week.

Baseline
GroupValue95% CI
Assessment-only Control12.23± 11.85
Cue Reactivity Personalized Feedback Intervention (PFI)11.78± 7.24
2-Week Follow-Up
GroupValue95% CI
Assessment-only Control10.31± 10.77
Cue Reactivity Personalized Feedback Intervention (PFI)9.40± 6.28
3-Month Follow-Up
GroupValue95% CI
Assessment-only Control7.54± 7.16
Cue Reactivity Personalized Feedback Intervention (PFI)8.49± 7.16
Number of Heavy Episodic Drinking Occasions Primary · Baseline, 2 week follow-up, and 3 month follow-up

Participants were asked, "During the past two weeks, how many times did you have \[4/5 for females/males\] or more drinks at one sitting?". Participants responded on a scale from 0 (0 times) to 10 (10 or more times) and possible range was 0-10.

Baseline
GroupValue95% CI
Assessment-only Control2.46± 2.32
Cue Reactivity Personalized Feedback Intervention (PFI)2.43± 1.97
2-Week Follow-Up
GroupValue95% CI
Assessment-only Control2.46± 2.10
Cue Reactivity Personalized Feedback Intervention (PFI)2.28± 1.72
3-Month Follow-Up
GroupValue95% CI
Assessment-only Control1.63± 1.82
Cue Reactivity Personalized Feedback Intervention (PFI)1.98± 1.93
Penn Alcohol Craving Scale Primary · Baseline, 2 week follow-up, and 3 month follow-up

Self-reported subjective alcohol craving during the past week. Response options were scored from "0" to "6" with text varying across items. A sum score of the five items was calculated and the possible range was from 0-30. Higher scores reflect more craving.

Baseline
GroupValue95% CI
Assessment-only Control6.58± 5.12
Cue Reactivity Personalized Feedback Intervention (PFI)7.92± 5.07
2-Week Follow-Up
GroupValue95% CI
Assessment-only Control7.80± 4.55
Cue Reactivity Personalized Feedback Intervention (PFI)8.66± 5.81
3-Month Follow-Up
GroupValue95% CI
Assessment-only Control5.80± 4.28
Cue Reactivity Personalized Feedback Intervention (PFI)7.46± 5.01
Brief Young Adult Alcohol Consequences Questionnaire Primary · Baseline, 2 week follow-up, and 3 month follow-up

Participants responded "no" (0) or "yes" (1) to whether they experienced each of 24 consequences during the \[past 3 months for baseline and 3-month follow-up; past two weeks for 2-week follow-up\]. A sum of the number of negative alcohol-related consequences was calculated and the possible range was 0-24.

Baseline
GroupValue95% CI
Assessment-only Control7.81± 5.02
Cue Reactivity Personalized Feedback Intervention (PFI)8.78± 4.13
2-Week Follow-Up
GroupValue95% CI
Assessment-only Control4.78± 4.35
Cue Reactivity Personalized Feedback Intervention (PFI)4.52± 3.61
3-Month Follow-Up
GroupValue95% CI
Assessment-only Control6.37± 5.65
Cue Reactivity Personalized Feedback Intervention (PFI)6.04± 5.12

Sponsor's own description

This study aims to develop a brief intervention that incorporates ecological momentary assessments (EMAs; i.e., four brief surveys per day for 17 days) to create personalized feedback targeting high-risk alcohol use among young adult drinkers. The intervention mainly focuses on providing feedback on individuals' drinking desire and how it varies as a function of a number of real-world factors. Other psycho-educational alcohol-related content is also provided in the intervention including strategies for decreasing exposure to cues that increase drinking desires and how to cope with increased desire to drink. This brief intervention will be used in a randomized controlled trial (RCT) comparing young adults who receive the intervention with those who only complete identical assessments.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Alcohol Craving and Cue Exposure in Real Time: A Pilot Ecological Momentary Assessment (EMA)-Based Personalized Feedback Intervention for Young Adults.
    Fairlie AM, Lee CM, Delawalla MLM, Ramirez JJ. · · 2026 · PMID 40833915 · DOI 10.15288/jsad.24-00447

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Other recruiting trials for Alcohol Drinking

Currently open trials in the same condition.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05373706.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing