CompletedNot Applicable

Project Guard: Reducing Alcohol Misuse/Abuse in the National Guard

United States850 participantsStarted 2017-03-01

Plain-language summary

The overall goal for the study is to test the efficacy of a smartphone app which includes an alcohol brief intervention (SP-BI) versus an Enhanced Usual Care (EUC) condition for National Guard members in the State of Ohio who meet criteria for at-risk drinking in the previous 4 months. The main hypothesis is that those in the SP-BI group with have reduced frequency and intensity of at-risk drinking and fewer binge drinking episodes.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Have a past 4-month AUDIT-C score of 5 or more for men and 4 or more for women indicating that they meet criteria for at-risk drinking, AND * Do not meet any of the exclusion criteria. * Must be a current or former member of the Ohio Army National Guard (OHARNG) or U.S. Army Reserve based in Ohio. Exclusion Criteria: * Those who do not have access to a smart phone with either Android or iOS operating system * Those in active treatment for substance use disorders (i.e., report addictions treatment in past 4 months) will be excluded because the proposed SBIRT intervention is focused on early brief intervention for those with at-risk drinking and on referral to treatment for those with more serious problems

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in the Number of Drinking Days as Assessed by the Audit-C

Timeframe: Change over time (Baseline, 4-, 8- and 12-months post baseline)

Change in the Number of Drinks per Day as Assessed by the Audit-C

Timeframe: Change over time (Baseline, 4-, 8- and 12-months post baseline)

Change in the Number of Binge Drinking Days as Assessed by the Audit-C

Timeframe: Change over time (Baseline, 4-, 8- and 12-months post baseline)

Trial details

NCT IDNCT02860442

SponsorKeming Gao

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-05-31

View on ClinicalTrials.gov More Alcohol Use trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in the Number of Drinking Days as Assessed by the Audit-C

Timeframe: Change over time (Baseline, 4-, 8- and 12-months post baseline)

Change in the Number of Drinks per Day as Assessed by the Audit-C

Timeframe: Change over time (Baseline, 4-, 8- and 12-months post baseline)

Change in the Number of Binge Drinking Days as Assessed by the Audit-C

Timeframe: Change over time (Baseline, 4-, 8- and 12-months post baseline)