AlcoholD3NCT06978140

Decisions During Drinking

A study testing Personalized feedback in people with Alcohol, 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 years
Conditions the study is for: Alcohol
What is being tested?: Personalized feedback
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 1 siteUnited States
Study dates: 18 Apr 2025to 10 Sep 2025
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
No healthy volunteers
Adult

Who may be able to join

Aged 18-24
At least 1 occurrence of heavy drinking in the past month
At least 2 alcohol related consequences in the past month
Live in Washington State
Agree to be randomized to receive intervention to assessment only control
Ability to receive SMS text-messages
Complete Identification verification

Who cannot join

Not meeting inclusion criteria
Not being able to verify identification

Trial locations and contacts

1 site in 1 country.

United States1 site

Center for the Study of Health and Risk Behavior, University of Washington
Seattle, Washington, 98195

Other trials in United States

About this study

Official title: Decisions During Drinking: Phase 3 Feasibility Study

Decisions during drinking (D3) is randomized clinical feasibility trial assessing whether health-related materials created for young adults who want to have more positive experiences if they decide to drink alcohol are acceptable and usable. Enrolled participants will be randomized to receive the health-related messages in 5-7 online modules over the 20-30 days or to only receive assessments. Those randomized to receive the intervention will also receive text-messages with health message content during the 20-30 days. After completing the intervention, participants will report on the usability and acceptability of the material, which is the main outcome. For secondary outcomes, participants in both the intervention and control will report on their drinking and drinking-related consequences in the post-intervention questionnaire (or 30 days after initial questionnaire for control participants) and 1 month later.

Conditions: Alcohol
Being tested: Personalized feedback
Keywords: alcohol-related consequences

What participants receive

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

Personalized feedbackBehavioural
Also called Decisions During Drinking
Material includes feedback on alcohol-related consequences with elements from Acceptance Commitment Therapy, Relapse Prevention, Cognitive Behavioral Therapy, and Behavioral Activation. Focus of the intervention is learning about personal environmental cues.

Study groups in NCT06978140
Study group	Role	What they receive
D3 online health information and text-messages	Experimental	Participants receiver personalized health information feedback across 5-7 online modules over 20-30 days along with text-message health information Receives: Behavioral: Personalized feedback
Assessment only control	No intervention	Participants will receive questionnaires similar to intervention group but will not receive any health information modules or related text-messages

What is being measured

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

Usability of Intervention
Usability of the intervention is assessed in the intervention group only using the System Usability Scale which is a 10-item scale with response options that range from 1 "strongly disagree" to 5 "strongly agree". Total scores were computed using the standard System Usability Scale score ( https://measuringu.com/sus/). Scores can range from 0 to 100. Scores of 68 are seen as average. Higher scores indicate greater usability
Measured: From invitation to the first intervention module to end of modules being available 37 days later
Acceptability of the Intervention
Acceptability of the intervention is assessed only in the intervention group using a questionnaire of 11 items each of which is participants will provide as response between 1 "Strongly Disagree" to 7 "Strongly Agree".
Measured: From invitation to the first intervention module to end of modules being available 37 days later
Feasibility of Intervention
Feasibility will be assessed by the percentage of participants randomized to the intervention that complete the intervention and the 1 month follow-up assessment
Measured: From invitation to the first intervention module to the end of the study 2 months later

Secondary outcomes (2)

Alcohol Consumption
Alcohol consumption will be assessed using the Daily drinking questionnaire, which assesses the number of drinks consumed each day in a typical week in the past month
Measured: From completion of baseline survey to 1 month follow-up approximately 67 days later
Alcohol Related Consequences
Past month alcohol related consequences will be assessed with 49 questions from several scales including the Rutgers Alcohol Problems Index, Young Adult Alcohol Problems Scale, and the Alcohol-Related Sexual Consequences. All questions except the Alcohol-Related Sexual Consequences are answered on a scale of 0 "Never" to 4 "More than 10 times". Alcohol-Related Sexual Consequences responses are 0 "No" and 1 "Yes" to indicate any occurrence in the past month.
Measured: From completion of baseline survey to 1 month follow-up approximately 67 days later

Timeline

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

18 Apr 202510 Sep 2025

First posted18 May 2025
Study start18 Apr 2025
Primary completion10 Sep 2025
Study completion10 Sep 2025

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 AlcoholStudies 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: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06978140
Sponsor's protocol ID: STUDY00021311
Other IDs: K01AA027771-05
Acronym: D3
Status last verified: Jan 2026
First submitted: 16 Apr 2025
Last updated: 8 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Data will be uploaded to NIAAA data archive (NIAAADA).

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

RecruitingPhase 1
PET Imaging of Phosphodiesterase-4B (PDE4B) in Alcohol Use Disorder
Alcohol Use Disorder
Recruiting
Safety and Effectiveness of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) for Treatment and Reduction of Heavy Drinking in Individuals With of Alcohol Use Disorder (AUD)
Alcohol Use Disorder, Alcoholism
Not yet recruitingObservational study
Inflammatory and Neuroimmune Guided Investigation of Underlying Fatigue in Patients With Cirrhosis
Cirrhosis Alcoholic, Fatigue Symptom
RecruitingPhase 1
Role of Metal Ion Transporter ZIP8 in Alcohol-Related Behaviors
Healthy Volunteer
Not yet recruiting
Hybrid Type 1 Trial of a Parent-Based Intervention Addressing Social Media and Adolescent Alcohol Use
Adolescent Alcohol Use

All Alcohol trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Decisions During Drinking: Phase 3 Feasibility Study
ClinicalTrials.gov ID: NCT06978140
Acronym / sponsor ID: D3 / STUDY00021311
Conditions: Alcohol
Keywords: alcohol-related consequences
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: University of WashingtonUniversity, hospital or other
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study start: 18 Apr 2025 (actual)
Primary completion: 10 Sep 2025 (actual)
Study completion: 10 Sep 2025 (actual)
First posted: 18 May 2025 (actual)
Results: Posted 8 Oct 2026

Clinical summary

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

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
D3 online health information and text-messages	Experimental	Behavioral: Personalized feedbackParticipants receiver personalized health information feedback across 5-7 online modules over 20-30 days along with text-message health information
Assessment only control	No intervention	–Participants will receive questionnaires similar to intervention group but will not receive any health information modules or related text-messages

Who may qualify

Ages: 18 to 24 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Aged 18-24
At least 1 occurrence of heavy drinking in the past month
At least 2 alcohol related consequences in the past month
Live in Washington State
Agree to be randomized to receive intervention to assessment only control

Key exclusion criteria (2 listed)

Not meeting inclusion criteria
Not being able to verify identification

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
Personalized feedbackAlso: Decisions During DrinkingMaterial includes feedback on alcohol-related consequences with elements from Acceptance Commitment Therapy, Relapse Prevention, Cognitive Behavioral Therapy, and Behavioral Activation. Focus of the intervention is learning about personal environmental cues.	Behavioural	D3 online health information and text-messages

Primary outcome

Usability of Intervention
Time frame: From invitation to the first intervention module to end of modules being available 37 days later
Usability of the intervention is assessed in the intervention group only using the System Usability Scale which is a 10-item scale with response options that range from 1 "strongly disagree" to 5 "strongly agree". Total scores were computed using the standard System Usability Scale score ( https://measuringu.com/sus/). Scores can range from 0 to 100. Scores of 68 are seen as average. Higher scores indicate greater usability
Acceptability of the Intervention
Time frame: From invitation to the first intervention module to end of modules being available 37 days later
Acceptability of the intervention is assessed only in the intervention group using a questionnaire of 11 items each of which is participants will provide as response between 1 "Strongly Disagree" to 7 "Strongly Agree".
Feasibility of Intervention
Time frame: From invitation to the first intervention module to the end of the study 2 months later
Feasibility will be assessed by the percentage of participants randomized to the intervention that complete the intervention and the 1 month follow-up assessment

2 secondary outcomes

Alcohol Consumption
Time frame: From completion of baseline survey to 1 month follow-up approximately 67 days later
Alcohol Related Consequences
Time frame: From completion of baseline survey to 1 month follow-up approximately 67 days later

Results and safety

Results posted to the registry on 8 Oct 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
D3 Online Health Information and Text-messages	18	13
Assessment Only Control	17	13

Primary outcome: Usability of Intervention

Time frame: From invitation to the first intervention module to end of modules being available 37 days later. Mean (Standard Deviation). Unit: Scores on a scale

Measure	D3 Online Health Information and Text-messages n = 16
Value	66.33 (15.49)

Primary outcome: Acceptability of the Intervention

Time frame: From invitation to the first intervention module to end of modules being available 37 days later. Mean (Standard Deviation). Unit: score on a scale

Measure	D3 Online Health Information and Text-messages n = 16
I carefully read the information in the D3 Modules	4.80 (1.74)
I found the information in D3 helpful.	4.60 (1.45)
I found the information in D3 acceptable.	5.53 (1.51)
I found the way the information in D3 was displayed acceptable.	5.33 (1.63)
I found the activities in D3 helpful.	4.80 (1.74)
I found the activities in D3 acceptable.	5.60 (1.06)
The info & activities provided will cause me to change my behaviors surrounding drinking alcohol.	4.33 (1.50)
I gained important skill(s) or tool(s) from D3.	4.67 (1.23)

Primary outcome: Feasibility of Intervention

Time frame: From invitation to the first intervention module to the end of the study 2 months later. Count of participants. Unit: Participants

Measure	D3 Online Health Information and Text-messages n = 16
Completed Intervention Post Assessment	14
Completed 1 Month Follow up	16

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment to end of follow up, about 67 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
D3 Online Health Information and Text-messages	0 of 18 (0%)	0 of 18 (0%)	0 of 18
Assessment Only Control	0 of 17 (0%)	0 of 17 (0%)	0 of 17

Limitations and caveats (from the sponsor): The small sample size limits the generalizability of findings and reduces the ability to detect significant effects. As a self-guided, online intervention, engagement likely varied based on participant motivation and day-to-day circumstances, which may have influenced how consistently participants completed modules and engaged with the material. We limited access to view the intervention material for up to 1 month.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Data will be uploaded to NIAAA data archive (NIAAADA).

Related trials for Alcohol

RecruitingPhase 1
PET Imaging of Phosphodiesterase-4B (PDE4B) in Alcohol Use Disorder
Alcohol Use Disorder
Recruiting
Safety and Effectiveness of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) for Treatment and Reduction of Heavy Drinking in Individuals With of Alcohol Use Disorder (AUD)
Alcohol Use Disorder, Alcoholism
Not yet recruitingObservational study
Inflammatory and Neuroimmune Guided Investigation of Underlying Fatigue in Patients With Cirrhosis
Cirrhosis Alcoholic, Fatigue Symptom
RecruitingPhase 1
Role of Metal Ion Transporter ZIP8 in Alcohol-Related Behaviors
Healthy Volunteer
Not yet recruiting
Hybrid Type 1 Trial of a Parent-Based Intervention Addressing Social Media and Adolescent Alcohol Use
Adolescent Alcohol Use

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.

Brittney Hultgren, 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 Personalized feedback in people with Alcohol, 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 8 Oct 2026. 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 8 Oct 2026). 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?

Usability of Intervention (time frame: From invitation to the first intervention module to end of modules being available 37 days later). The study lists 3 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 NCT06978140.

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 8 Oct 2026.