Alcohol ConsumptionProject ACENCT05873556

Testing Brief Personalized Feedback Integrating Lab-based Alcohol Cue Information

A study testing Lab-based Cue Reactivity Personalized Feedback Intervention (PFI) in people with Alcohol Consumption, run by University of Washington at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 24 yearsHealthy volunteers can take part
Conditions the study is for: Alcohol Consumption
What is being tested?: Lab-based Cue Reactivity Personalized Feedback Intervention (PFI)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 93 participants
Where: 1 siteUnited States
Study dates: 8 May 2023to 25 Mar 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 24 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Between ages 18-24
Lives in Washington state
Reports drinking at least two days per week in the last six months
Reports at least one heavy drinking episode (4+/5+ drinks for women/men) in the past month
Open to changing drinking behavior
Must be willing to come to our Seattle study office for session visit
Provide an email address and phone number for study communication

Who cannot join

Actively seeking treatment for alcohol use
Currently participating in another study in our research center regarding young adult drinking behavior

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Washington
Seattle, Washington, 98195

Other trials in United States

About this study

Official title: Development and Preliminary Examination of Two Brief Personalized Feedback Interventions Focused on Lab-based and EMA Alcohol Cues to Reduce Hazardous Young Adult Alcohol Use

This study aims to develop a brief intervention that uses information from a lab-based cue reactivity protocol to create personalized feedback targeting high-risk alcohol use among young adults who drink alcohol. The intervention provides feedback on individuals' drinking desire, mood, willingness to drink, and alcohol demand by comparing scores before and after viewing and smelling an alcoholic beverage in the lab session. 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 is used in a randomized controlled trial (RCT) comparing young adults who receive the brief, online intervention to those who did not receive the brief, online intervention. Participants in both groups complete baseline, lab-based cue reactivity protocol, 2-week follow-up and 3-month follow-up.

Read the detailed description

The purpose of this study is to develop and test a brief intervention that provides personalized feedback to young adults using participants' responses from a baseline survey and from a lab-based cue reactivity protocol. The aim of the intervention is to increase young adults' awareness of how alcohol cues may affect their desire to drink, mood, willingness to drink, and alcohol demand both in relation to lab-based exposure to an alcohol beverage of their choice and also more broadly in everyday life. The intervention also aims to equip young adults with strategies for reducing exposure to factors that increase their desire to drink, how to cope with an increased desire to drink, and how to reduce potential harms from drinking.

This brief personalized feedback intervention is used in a randomized controlled trial comparing young adults who receive the intervention with those who complete the assessments and lab protocol but do not receive any personalized feedback. Online assessments include an eligibility survey, baseline assessment, and follow-up assessments occurring 2-weeks and 3-months post-intervention. Everyone has one in-person session to complete the lab-based cue reactivity protocol after the baseline assessment has been completed online. The intervention will be examined for its feasibility, acceptability, and its effects in reducing alcohol-related outcomes at the follow-up assessments.

Conditions: Alcohol Consumption
Being tested: Lab-based Cue Reactivity Personalized Feedback Intervention (PFI)
Medical subject headings: Alcohol Drinking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lab-based Cue Reactivity Personalized Feedback Intervention (PFI)Behavioural
This is an online personalized feedback intervention that contains information summarizing participants' desire to drink, mood, willingness to drink, and alcohol demand as reported before and after alcohol exposure.

Study groups in NCT05873556
Study group	Role	What they receive
Lab-based Cue Reactivity Personalized Feedback Intervention (PFI)	Experimental	Participants randomized to the Lab-based Cue Reactivity PFI condition view the online personalized feedback in the lab after completing the cue reactivity protocol. Participants view the feedback on their own during the lab session. The personalized feedback is delivered online and contains information summarizing participants' desire to drink, mood, willingness to drink, and alcohol demand as reported before and after alcohol exposure. Receives: Behavioral: Lab-based Cue Reactivity Personalized Feedback Intervention (PFI)
Assessment-only control	No intervention	Participants randomized to the control group do not receive any intervention. They complete all the survey assessments and the lab-based cue reactivity protocol without ever receiving any personalized feedback.

What is being measured

The primary outcome is the main question the study is designed to answer.

Daily Drinking Questionnaire
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.
Measured: Baseline, 2 week follow-up, and 3 month follow-up
Heavy Episodic Drinking
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.
Measured: Baseline, 2 week follow-up, and 3 month follow-up
Penn Alcohol Craving Scale
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.
Measured: Baseline, 2 week follow-up, and 3 month follow-up
Brief Young Adult Alcohol Consequences Questionnaire
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. Higher values represent a worse outcome (i.e., more consequences).
Measured: Baseline, 2 week follow-up, and 3 month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 May 202325 Mar 2024

First posted24 May 2023
Study start8 May 2023
Primary completion25 Mar 2024
Study completion25 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Alcohol ConsumptionStudies of the same condition, open and under way.
More trials run by University of WashingtonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Participants will be randomly assigned to one of two conditions: (1) Personalized feedback based on reports from baseline and lab-session and (2) assessment-only control group.
Masking: None (open label)
Enrolment: 93 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05873556
Sponsor's protocol ID: STUDY00016989
Other IDs: R34AA027302
Acronym: Project ACE
Status last verified: Mar 2025
First submitted: 15 May 2023
Last updated: 25 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: The investigators plan to share limited, de-identified datasets for the purposes of data analysis and dissemination.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Alcohol Consumption trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Development and Preliminary Examination of Two Brief Personalized Feedback Interventions Focused on Lab-based and EMA Alcohol Cues to Reduce Hazardous Young Adult Alcohol Use
ClinicalTrials.gov ID: NCT05873556
Acronym / sponsor ID: Project ACE / STUDY00016989
Conditions: Alcohol Consumption
Study type: Interventional
Recruitment status: Completed
Enrolment: 93 participants (actual)
Lead sponsor: University of WashingtonUniversity, hospital or other
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study start: 8 May 2023 (actual)
Primary completion: 25 Mar 2024 (actual)
Study completion: 25 Mar 2024 (actual)
First posted: 24 May 2023 (actual)
Results: Posted 25 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Participants will be randomly assigned to one of two conditions: (1) Personalized feedback based on reports from baseline and lab-session and (2) assessment-only control group.

Arm	Type	Receives
Lab-based Cue Reactivity Personalized Feedback Intervention (PFI)	Experimental	Behavioral: Lab-based Cue Reactivity Personalized Feedback Intervention (PFI)Participants randomized to the Lab-based Cue Reactivity PFI condition view the online personalized feedback in the lab after completing the cue reactivity protocol. Participants view the feedback on their own during the lab session. The personalized feedback is delivered online and contains information summarizing participants' desire to drink, mood, willingness to drink, and alcohol demand as reported before and after alcohol exposure.
Assessment-only control	No intervention	–Participants randomized to the control group do not receive any intervention. They complete all the survey assessments and the lab-based cue reactivity protocol without ever receiving any personalized feedback.

Who may qualify

Ages: 18 to 24 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Between ages 18-24
Lives in Washington state
Reports drinking at least two days per week in the last six months
Reports at least one heavy drinking episode (4+/5+ drinks for women/men) in the past month
Open to changing drinking behavior

Key exclusion criteria (2 listed)

Actively seeking treatment for alcohol use
Currently participating in another study in our research center regarding young adult drinking behavior

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Lab-based Cue Reactivity Personalized Feedback Intervention (PFI)This is an online personalized feedback intervention that contains information summarizing participants' desire to drink, mood, willingness to drink, and alcohol demand as reported before and after alcohol exposure.	Behavioural	Lab-based Cue Reactivity Personalized Feedback Intervention (PFI)

Primary outcome

Daily Drinking Questionnaire
Time frame: 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.
Heavy Episodic Drinking
Time frame: 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.
Penn Alcohol Craving Scale
Time frame: 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.
Brief Young Adult Alcohol Consequences Questionnaire
Time frame: 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. Higher values represent a worse outcome (i.e., more consequences).

Results and safety

Results posted to the registry on 25 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Assessment-only Control	42	38
Lab-based Cue Reactivity Personalized Feedback Intervention (PFI)	51	50

Primary outcome: Daily Drinking Questionnaire

Time frame: Baseline, 2 week follow-up, and 3 month follow-up. Mean (Standard Deviation). Unit: Drinks per week

Measure	Assessment-only Control n = 42	Lab-based Cue Reactivity Personalized Feedback Intervention (PFI) n = 51
Baseline	10.24 (5.16)	12.27 (7.95)
2-Week Follow-Up	8.79 (7.25)	9.73 (6.95)
3-Month Follow-Up	6.97 (5.46)	9.14 (7.70)

Assessment-only Control vs Lab-based Cue Reactivity Personalized Feedback Intervention (PFI): Count/Rate Ratio: 0.97 (95% CI 0.74 to 1.27), p = 0.83, Generalized linear mixed model
Assessment-only Control vs Lab-based Cue Reactivity Personalized Feedback Intervention (PFI): Count/Rate Ratio: 1.07 (95% CI 0.83 to 1.38), p = 0.61, Generalized linear mixed model

Primary outcome: Heavy Episodic Drinking

Time frame: Baseline, 2 week follow-up, and 3 month follow-up. Mean (Standard Deviation). Unit: Heavy Drinking Occasions

Measure	Assessment-only Control n = 42	Lab-based Cue Reactivity Personalized Feedback Intervention (PFI) n = 51
Baseline	2.45 (1.92)	2.47 (2.17)
2-Week Follow-Up	1.86 (1.78)	2.18 (1.75)
3-Month Follow-Up	1.53 (1.37)	1.86 (1.95)

Assessment-only Control vs Lab-based Cue Reactivity Personalized Feedback Intervention (PFI): Count/Rate Ratio: 1.16 (95% CI 0.79 to 1.72), p = 0.45, Generalized linear mixed model
Assessment-only Control vs Lab-based Cue Reactivity Personalized Feedback Intervention (PFI): Count/Rate Ratio: 1.17 (95% CI 0.77 to 1.79), p = 0.46, Generalized linear mixed model

Primary outcome: Penn Alcohol Craving Scale

Time frame: Baseline, 2 week follow-up, and 3 month follow-up. Mean (Standard Deviation). Unit: Score on a scale

Measure	Assessment-only Control n = 42	Lab-based Cue Reactivity Personalized Feedback Intervention (PFI) n = 51
Baseline	6.93 (3.96)	8.04 (4.11)
2-Week Follow-Up	7.31 (4.81)	8.04 (5.44)
3-Month Follow-Up	5.74 (4.23)	7.24 (5.09)

Assessment-only Control vs Lab-based Cue Reactivity Personalized Feedback Intervention (PFI): Count/Rate Ratio: 0.95 (95% CI 0.77 to 1.17), p = 0.62, Generalized linear mixed model
Assessment-only Control vs Lab-based Cue Reactivity Personalized Feedback Intervention (PFI): Count/Rate Ratio: 1.14 (95% CI 0.87 to 1.48), p = 0.34, Generalized linear mixed model

Primary outcome: Brief Young Adult Alcohol Consequences Questionnaire

Time frame: Baseline, 2 week follow-up, and 3 month follow-up. Mean (Standard Deviation). Unit: Score on a scale

Measure	Assessment-only Control n = 42	Lab-based Cue Reactivity Personalized Feedback Intervention (PFI) n = 51
Baseline	8.74 (5.18)	9.92 (5.02)
2-Week Follow-Up	4.88 (4.80)	5.78 (5.11)
3-Month Follow-Up	6.11 (5.26)	7.06 (5.37)

Assessment-only Control vs Lab-based Cue Reactivity Personalized Feedback Intervention (PFI): Count/Rate Ratio: 1.08 (95% CI 0.76 to 1.54), p = 0.66, Generalized linear mixed model
Assessment-only Control vs Lab-based Cue Reactivity Personalized Feedback Intervention (PFI): Count/Rate Ratio: 1.02 (95% CI 0.75 to 1.38), p = 0.92, Generalized linear mixed model

Adverse events

Time frame: Adverse event data were collected between initial screening and final follow-up for each participant, a period of approximately 4 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Assessment-only Control	0 of 42 (0%)	0 of 42 (0%)	0 of 42
Lab-based Cue Reactivity Personalized Feedback Intervention (PFI)	0 of 51 (0%)	0 of 51 (0%)	0 of 51

Limitations and caveats (from the sponsor): This is a small pilot trial designed to collect feasibility and acceptability information. The study (enrollment through 3-month) went from May 2023 to March 2024; the COVID-19 pandemic may have impacted alcohol use and contexts of alcohol use. All findings are based on self-report of alcohol use. Analyses reported here restrict the sample to 93 to account for a programming error (subsequently fixed) where control participants were initially being incorrectly emailed a link to the feedback.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. The investigators plan to share limited, de-identified datasets for the purposes of data analysis and dissemination.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jason Ramirez, PhD principal investigator

University of Washington

Anne Fairlie, PhD principal investigator

University of Washington

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Lab-based Cue Reactivity Personalized Feedback Intervention (PFI) in people with Alcohol Consumption, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Daily Drinking Questionnaire (time frame: Baseline, 2 week follow-up, and 3 month follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05873556.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.