Alcohol DrinkingProject ACENCT05373706

Testing Brief Personalized Feedback Integrating EMA Alcohol Cue Information

A study testing Alcohol Cue Reactivity Personalized Feedback Intervention in people with Alcohol Drinking and Problem Drinking, 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

Search all trials

Trial summary

Who is it for?: Ages 18 to 24 yearsHealthy volunteers can take part
Conditions the study is for: Alcohol Drinking, Problem Drinking
What is being tested?: Alcohol Cue Reactivity Personalized Feedback Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 99 participants
Where: 1 siteUnited States
Study dates: 29 Apr 2022to 1 May 2023
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

1) Between ages 18-24, 2) Lives in Washington state, 3) Reports drinking at least two days per week in the last six months, 4) Reports at least one heavy drinking episode (4+/5+ drinks for women/men) in the past month, 5) Open to changing drinking behavior, 6) Schedule allows for participation in study with daily surveys, 7) Able to attend Zoom training session, 8) Must have cellphone for daily surveys.

Who cannot join

1) Actively seeking treatment for alcohol use, 2) 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, 98155

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 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.

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' own event-level, real-world experiences. The aim of the intervention is to increase young adults' awareness of their desire to drink as it varies as a function of a number of real-world factors including alcohol cues, social context, physical context, anticipation of later drinking, mood, and time of day. 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 EMAs but do not receive any personalized feedback. Assessments include an eligibility survey, baseline assessment, 17 days of EMAs (4x/day), and follow-up assessments occurring 2-weeks and 3-months post-intervention. The 2-week and 3-month follow-ups occurred 2-weeks and 3-months, respectively, from Day 17 of the EMA period, because the intervention was delivered on Day 17. The intervention will be examined for its feasibility, acceptability, and its effects in reducing alcohol-related outcomes at the follow-up assessments.

Conditions: Alcohol Drinking, Problem Drinking
Being tested: Alcohol Cue Reactivity Personalized Feedback Intervention
Keywords: Alcohol, Intervention, Young Adults, Personalized Feedback
Medical subject headings: Alcohol Drinking, Alcoholism

What participants receive

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

Alcohol Cue Reactivity Personalized Feedback InterventionBehavioural
This online brief intervention provides personalized feedback using EMA data focused on alcohol cue reactivity to reduce alcohol misuse among young adults.

Study groups in NCT05373706
Study group	Role	What they receive
Cue Reactivity Personalized Feedback Intervention (PFI)	Experimental	Participants randomized to the Cue Reactivity PFI condition will receive personalized feedback at the end of completing 17 days of ecological momentary assessments (EMAs) four times a day. The personalized feedback will be delivered online and contains information summarizing participants' desire to drink as it varied as a function of several real-world factors across the 17-day EMA period. Receives: Behavioral: Alcohol Cue Reactivity Personalized Feedback Intervention
Assessment-only control	No intervention	Participants randomized to the control group will not receive any intervention. They will be an assessment-only control group.

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
Number of Heavy Episodic Drinking Occasions
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.
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.

29 Apr 20221 May 2023

First posted13 May 2022
Study start29 Apr 2022
Primary completion1 May 2023
Study completion1 May 2023

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 DrinkingStudies 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 (Personalized feedback and assessment-only control group).
Masking: None (open label)
Enrolment: 99 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05373706
Sponsor's protocol ID: STUDY00014778
Other IDs: 1R34AA027302-01A1
Acronym: Project ACE
Status last verified: Jun 2024
First submitted: 9 May 2022
Last updated: 4 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: We 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

Not yet recruitingEarly Phase 1
Pain Sensitivity, Alcohol-Induced Analgesia, and Heavy Drinking in Individuals With Opioid Use Disorder
Opioid Use Disorder, Alcohol Intoxication
RecruitingPhase 1
Nicotinic Receptor Genetic Variation and Alcohol Reward
Alcohol Drinking
RecruitingPhase 2
Psilocybin-assisted Therapy for Comorbid Major Depressive Disorder and Alcohol Use Disorder
Major Depressive Disorder (MDD), Alcohol Use Disorder (AUD)
Not yet recruitingEarly Phase 1
Examining the Role of Sensitivity to Uncertain Threat and Alcohol Response in Risk for Alcohol Use Disorder Following Sexual Assault in College Women
Sexual Assault, Alcohol Intoxication
RecruitingObservational study
NIAAA Natural History Protocol
Alcohol Use Disorder

All Alcohol Drinking trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2024. 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: NCT05373706
Acronym / sponsor ID: Project ACE / STUDY00014778
Conditions: Alcohol Drinking, Problem Drinking
Keywords: Alcohol, Intervention, Young Adults, Personalized Feedback
Study type: Interventional
Recruitment status: Completed
Enrolment: 99 participants (actual)
Lead sponsor: University of WashingtonUniversity, hospital or other
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study start: 29 Apr 2022 (actual)
Primary completion: 1 May 2023 (actual)
Study completion: 1 May 2023 (actual)
First posted: 13 May 2022 (actual)
Results: Posted 4 Jun 2024

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 (Personalized feedback and assessment-only control group).

Arm	Type	Receives
Cue Reactivity Personalized Feedback Intervention (PFI)	Experimental	Behavioral: Alcohol Cue Reactivity Personalized Feedback InterventionParticipants randomized to the Cue Reactivity PFI condition will receive personalized feedback at the end of completing 17 days of ecological momentary assessments (EMAs) four times a day. The personalized feedback will be delivered online and contains information summarizing participants' desire to drink as it varied as a function of several real-world factors across the 17-day EMA period.
Assessment-only control	No intervention	–Participants randomized to the control group will not receive any intervention. They will be an assessment-only control group.

Who may qualify

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

Key inclusion criteria (1 listed)

1) Between ages 18-24, 2) Lives in Washington state, 3) Reports drinking at least two days per week in the last six months, 4) Reports at least one heavy drinking episode (4+/5+ drinks for women/men) in the past month, 5) Open to changing drinking behavior, 6) Schedule allows for participation in study with daily surveys, 7) Able to attend Zoom training session, 8) Must have cellphone for daily surveys.

Key exclusion criteria (1 listed)

1) Actively seeking treatment for alcohol use, 2) 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
Alcohol Cue Reactivity Personalized Feedback InterventionThis online brief intervention provides personalized feedback using EMA data focused on alcohol cue reactivity to reduce alcohol misuse among young adults.	Behavioural	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.
Number of Heavy Episodic Drinking Occasions
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.

Results and safety

Results posted to the registry on 4 Jun 2024, 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	48	46
Cue Reactivity Personalized Feedback Intervention (PFI)	51	49

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 = 48	Cue Reactivity Personalized Feedback Intervention (PFI) n = 51
Baseline	12.23 (11.85)	11.78 (7.24)
2-Week Follow-Up	10.31 (10.77)	9.40 (6.28)
3-Month Follow-Up	7.54 (7.16)	8.49 (7.16)

Assessment-only Control vs Cue Reactivity Personalized Feedback Intervention (PFI): Count/Rate Ratio: 0.95 (95% CI 0.76 to 1.20), p = 0.68, Generalized linear mixed model
Assessment-only Control vs Cue Reactivity Personalized Feedback Intervention (PFI): Count/Rate Ratio: 1.10 (95% CI 0.81 to 1.49), p = 0.56, Generalized linear mixed model

Population analysed: Young adults

Primary outcome: Number of Heavy Episodic Drinking Occasions

Time frame: Baseline, 2 week follow-up, and 3 month follow-up. Mean (Standard Deviation). Unit: Number heavy episodic drinking occasions

Measure	Assessment-only Control n = 48	Cue Reactivity Personalized Feedback Intervention (PFI) n = 51
Baseline	2.46 (2.32)	2.43 (1.97)
2-Week Follow-Up	2.46 (2.10)	2.28 (1.72)
3-Month Follow-Up	1.63 (1.82)	1.98 (1.93)

Assessment-only Control vs Cue Reactivity Personalized Feedback Intervention (PFI): Count/Rate Ratio: 0.93 (95% CI 0.64 to 1.33), p = 0.68, Generalized linear mixed model
Assessment-only Control vs Cue Reactivity Personalized Feedback Intervention (PFI): Count/Rate Ratio: 1.24 (95% CI 0.82 to 1.88), p = 0.30, Generalized linear mixed model

Population analysed: Young adults

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 = 48	Cue Reactivity Personalized Feedback Intervention (PFI) n = 51
Baseline	6.58 (5.12)	7.92 (5.07)
2-Week Follow-Up	7.80 (4.55)	8.66 (5.81)
3-Month Follow-Up	5.80 (4.28)	7.46 (5.01)

Assessment-only Control vs Cue Reactivity Personalized Feedback Intervention (PFI): Count/Rate Ratio: 0.89 (95% CI 0.69 to 1.15), p = 0.36, Generalized linear mixed model
Assessment-only Control vs Cue Reactivity Personalized Feedback Intervention (PFI): Count/Rate Ratio: 1.05 (95% CI 0.80 to 1.38), p = 0.73, Generalized linear mixed model

Population analysed: Young adults

Primary outcome: Brief Young Adult Alcohol Consequences Questionnaire

Time frame: Baseline, 2 week follow-up, and 3 month follow-up. Mean (Standard Deviation). Unit: Number of consequences (range 0-24)

Measure	Assessment-only Control n = 48	Cue Reactivity Personalized Feedback Intervention (PFI) n = 51
Baseline	7.81 (5.02)	8.78 (4.13)
2-Week Follow-Up	4.78 (4.35)	4.52 (3.61)
3-Month Follow-Up	6.37 (5.65)	6.04 (5.12)

Assessment-only Control vs Cue Reactivity Personalized Feedback Intervention (PFI): Count/Rate Ratio: 0.83 (95% CI 0.66 to 1.04), p = 0.11, Generalized linear mixed model
Assessment-only Control vs Cue Reactivity Personalized Feedback Intervention (PFI): Count/Rate Ratio: 0.88 (95% CI 0.66 to 1.17), p = 0.38, Generalized linear mixed model

Population analysed: Young adults

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 48 (0%)	0 of 48 (0%)	0 of 48
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. Study data were collected during the COVID-19 pandemic from April 2022 through May 2023, which may have impacted alcohol use and contexts of alcohol use among young adult participants. All findings are based on self-report of alcohol use.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. We plan to share limited, de-identified datasets for the purposes of data analysis and dissemination.

Related trials for Alcohol Drinking

Not yet recruitingEarly Phase 1
Pain Sensitivity, Alcohol-Induced Analgesia, and Heavy Drinking in Individuals With Opioid Use Disorder
Opioid Use Disorder, Alcohol Intoxication
RecruitingPhase 1
Nicotinic Receptor Genetic Variation and Alcohol Reward
Alcohol Drinking
RecruitingPhase 2
Psilocybin-assisted Therapy for Comorbid Major Depressive Disorder and Alcohol Use Disorder
Major Depressive Disorder (MDD), Alcohol Use Disorder (AUD)
Not yet recruitingEarly Phase 1
Examining the Role of Sensitivity to Uncertain Threat and Alcohol Response in Risk for Alcohol Use Disorder Following Sexual Assault in College Women
Sexual Assault, Alcohol Intoxication
RecruitingObservational study
NIAAA Natural History Protocol
Alcohol Use Disorder

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 Alcohol Cue Reactivity Personalized Feedback Intervention in people with Alcohol Drinking and Problem Drinking, 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 1 inclusion and 1 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 4 Jun 2024. 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 4 Jun 2024). 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 NCT05373706.

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 4 Jun 2024.