Binge Drinking, Underage Drinking, Drinking and Driving, Alcohol-Related HarmsGSDGNCT03262259
Evaluation of Global Smart Drinking Goals Initiative
A study testing GSDG multi-component intervention in people with Binge Drinking, Underage Drinking, Drinking and Driving, Alcohol-Related Harms, run by HBSA at 1 site in United States.
Trial summary
This study will evaluate effects of a multi-component, population-level intervention on alcohol use and related harms in six intervention cities relative to six matched comparison cities. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Binge Drinking, Underage Drinking, Drinking and Driving, Alcohol-Related Harms
- What is being tested?
- GSDG multi-component intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2017to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- At least 12 years old
- Parental consent is be required if under 18 years old
Who cannot join
- Institutionalized individuals
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
HBSA
Calverton, Maryland, 20705
Ted Miller, Ph.D., 301-593-7471, miller@pire.org
About this study
Official title: Measurement and Evaluation of Global Smart Drinking Goals Initiative
This study will evaluate effects of a multi-component, population-level intervention on alcohol use and related harms in six intervention cities relative to six matched comparison cities. Intervention components include screening and brief interventions by health providers, other evidence-based interventions (e.g., enforcement of drink-driving or underage drinking laws), and novel or partially tested interventions that warrant further evaluation. Key outcomes of interest include alcohol-related harms such as alcohol-related motor vehicle crashes and fatalities, heavy/binge drinking, underage drinking, and drinking and driving.
Read the detailed description
This study will evaluate effects of a multi-component, population-level intervention on alcohol use and related harms in six intervention cities relative to six matched comparison cities. The trial is expected to expand to nine intervention and nine comparison cities in 2018. Intervention components include screening and brief interventions by health providers, other evidence-based interventions (e.g., enforcement of drink-driving or underage drinking laws), and novel or partially tested interventions that warrant further evaluation. Key outcomes of interest include alcohol-related harms such as alcohol-related motor vehicle crashes and fatalities, heavy/binge drinking, underage drinking, and drinking and driving.
Multiple years of pre- and post-intervention survey data will be collected from cross-sectional samples of adults and youth in each city to assess intervention effects on harmful alcohol use. Multiple years of archival data will also be collected from each city to assess intervention effects on alcohol-related harms such as motor vehicle crashes and fatalities, violence and unintentional injuries. Multi-level analyses will be conducted with data for the total sample of 18 cities and for each pair of cities to determine whether the overall goal of reducing harmful alcohol use by at least 10% is achieved.
- Being tested
- GSDG multi-component intervention
- Medical subject headings
- Binge Drinking, Underage Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSDG multi-component interventionBehavioural
Multi-component intervention, including screening and brief intervention, other evidence-based interventions, and novel or partially tested interventions that warrant further evaluation.
| Study group | Role | What they receive |
|---|---|---|
| GSDG Intervention | Experimental | Cities receiving a multi-component intervention, including screening and brief intervention, other evidence-based interventions (e.g., enforcement of drink-driving or underage drinking laws), and novel or partially tested interventions that warrant further evaluation. Receives: Behavioral: GSDG multi-component intervention |
| Comparison | No intervention | Comparison cities receiving no evidence-based interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health and social harms related to alcohol use
Self-reported problems related to alcohol use (e.g., drinking and driving, injury, unwanted sex, vandalism, property crime); alcohol-related motor vehicle crashes and fatalities
Measured: 1 year
Secondary outcomes (10)
Heavy/binge drinking
Self-reported heavy alcohol use (e.g., 5+ drinks within 2 hours)
Measured: 1 year
Underage drinking
Self-reported alcohol use
Measured: 1 year
Perceived alcohol use and alcohol-related attitudes among family and friends
Beliefs regarding alcohol use among family and friends, and acceptability of alcohol use
Measured: 1 year
Alcohol expectancies
Expectations regarding positive and negative consequences of alcohol use
Measured: 1 year
Awareness of alcohol policies
Knowledge of policies such as the minimum legal drinking age and maximum allowable blood alcohol concentration limit for driving
Measured: 1 year
Perceived enforcement of alcohol policies
Perceived likelihood of being asked for age identification, being stopped by police for drinking and driving, etc.
Measured: 1 year
Awareness of chronic health risks associated with alcohol use
Self-reported knowledge of possible chronic health-related consequences of alcohol use (e.g., liver cirrhosis, coronary heart disease)
Measured: 1 year
Awareness of alcohol health guidance labels and information
Self-reported knowledge of guidance labels and information on beer bottles, cans and elsewhere
Measured: 1 year
Consumption of no-alcohol and low-alcohol beer
Self-reported consumption (quantity and frequency) of no-alcohol and low-alcohol beer, no-alcohol and low-alcohol beer sales, underage use of no-alcohol and low-alcohol beer
Measured: 1 year
Screening and brief intervention for heavy/binge drinking
Self-reported frequency and impacts, archival medical record data
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start1 Sep 2017
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Binge Drinking, Underage Drinking, Drinking and Driving, Alcohol-Related HarmsStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Nine pairs of intervention and comparison cities followed over multiple years.
- Masking
- None (open label)
- Enrolment
- 36,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HBSA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ted Miller, Ph.D., Principal investigator, HBSA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03262259
- Sponsor's protocol ID
- 0881
- Acronym
- GSDG
- Status last verified
- Aug 2025
- First submitted
- 21 Aug 2017
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified survey and archival data collected for the evaluation will be made available upon completion of the study.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement and Evaluation of Global Smart Drinking Goals Initiative
- ClinicalTrials.gov ID
- NCT03262259
- Acronym / sponsor ID
- GSDG / 0881
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36,000 participants (estimated)
- Lead sponsor
- HBSAUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 25 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate effects of a multi-component, population-level intervention on alcohol use and related harms in six intervention cities relative to six matched comparison cities. Intervention components include screening and brief interventions by health providers, other evidence-based interventions (e.g., enforcement of drink-driving or underage drinking laws), and novel or partially tested interventions that warrant further evaluation. Key outcomes of interest include alcohol-related harms such as alcohol-related motor vehicle crashes and fatalities, heavy/binge drinking, underage drinking, and drinking and driving.
Detailed description
This study will evaluate effects of a multi-component, population-level intervention on alcohol use and related harms in six intervention cities relative to six matched comparison cities. The trial is expected to expand to nine intervention and nine comparison cities in 2018. Intervention components include screening and brief interventions by health providers, other evidence-based interventions (e.g., enforcement of drink-driving or underage drinking laws), and novel or partially tested interventions that warrant further evaluation. Key outcomes of interest include alcohol-related harms such as alcohol-related motor vehicle crashes and fatalities, heavy/binge drinking, underage drinking, and drinking and driving.
Multiple years of pre- and post-intervention survey data will be collected from cross-sectional samples of adults and youth in each city to assess intervention effects on harmful alcohol use. Multiple years of archival data will also be collected from each city to assess intervention effects on alcohol-related harms such as motor vehicle crashes and fatalities, violence and unintentional injuries. Multi-level analyses will be conducted with data for the total sample of 18 cities and for each pair of cities to determine whether the overall goal of reducing harmful alcohol use by at least 10% is achieved.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Nine pairs of intervention and comparison cities followed over multiple years.
| Arm | Type | Receives |
|---|---|---|
| GSDG Intervention | Experimental | Behavioral: GSDG multi-component interventionCities receiving a multi-component intervention, including screening and brief intervention, other evidence-based interventions (e.g., enforcement of drink-driving or underage drinking laws), and novel or partially tested interventions that warrant further evaluation. |
| Comparison | No intervention | –Comparison cities receiving no evidence-based interventions. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- At least 12 years old
- Parental consent is be required if under 18 years old
Key exclusion criteria (1 listed)
- Institutionalized individuals
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 |
|---|---|---|
| GSDG multi-component interventionMulti-component intervention, including screening and brief intervention, other evidence-based interventions, and novel or partially tested interventions that warrant further evaluation. | Behavioural | GSDG Intervention |
Primary outcome
Health and social harms related to alcohol use
Time frame: 1 year
Self-reported problems related to alcohol use (e.g., drinking and driving, injury, unwanted sex, vandalism, property crime); alcohol-related motor vehicle crashes and fatalities
10 secondary outcomes
Heavy/binge drinking
Time frame: 1 year
Underage drinking
Time frame: 1 year
Perceived alcohol use and alcohol-related attitudes among family and friends
Time frame: 1 year
Alcohol expectancies
Time frame: 1 year
Awareness of alcohol policies
Time frame: 1 year
Perceived enforcement of alcohol policies
Time frame: 1 year
Awareness of chronic health risks associated with alcohol use
Time frame: 1 year
Awareness of alcohol health guidance labels and information
Time frame: 1 year
Consumption of no-alcohol and low-alcohol beer
Time frame: 1 year
Screening and brief intervention for heavy/binge drinking
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Individual participant dataSharing planned: Yes. De-identified survey and archival data collected for the evaluation will be made available upon completion of the study.
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.
Ted Miller, Ph.D. principal investigator
HBSA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GSDG multi-component intervention in people with Binge Drinking, Underage Drinking, Drinking and Driving, Alcohol-Related Harms, run by HBSA 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 2 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: looking for participants now, as of the sponsor's last update on 3 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mary V Gordon (3017552752, gordon@pire.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health and social harms related to alcohol use (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Sep 2025.