Harmful DrinkingNCT00443183
Emergency Physician Brief Interventions for Alcohol
A study testing Brief Negotiation Interview (BNI) and Discharge Instructions in people with Harmful Drinking and Hazardous Drinking, run by Yale University at 1 site in United States.
Trial summary
Patients with hazardous and harmful alcohol consumption are at increased risk for adverse health consequences and have frequent visits to the Emergency Department(ED). Despite research that has demonstrated the prevalence of alcohol problems in ED patients, there are limited data on the effectiveness of brief… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Harmful Drinking, Hazardous Drinking
- What is being tested?
- Brief Negotiation Interview (BNI) and Discharge Instructions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- May 2002to Nov 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients, 18 years or older who present to the adult ED at Yale-New Haven Hospital will be screened for the NIAAA criteria for at risk drinking( ) namely:
- Men: > 14 drinks per week or > 4 drinks per occasion
- Women \&: > 7 drinks per week or (all >65) > 3 drinks per occasion
- or will be considered to screen positive for harmful drinking, if they exhibit any current injury or medical condition occurring in the setting of acute alcohol ingestion as determined by a) self-report; b)serum or breathalyzer test with a blood alcohol concentration (BAC) > 0.02mg%;( , , ) or c) a history of any injury or medical condition involving the use of alcohol within the past year.
Who cannot join
- Patients will be excluded for the following:
- Non-English speaking;
- Pregnancy;
- Alcohol dependence;
- Current enrollment in substance abuse treatment program;
- Current cocaine or illicit opiate use;
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- Current ED visit for acute psychiatric complaint;
- History of neuroleptic prescription;
- Hospitalization for psychiatric problem in the past year;
- Condition that precludes interview i.e., life threatening injury/illness;
- In police custody; and
- Inability to provide 2 contact numbers for follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Patients with hazardous and harmful alcohol consumption are at increased risk for adverse health consequences and have frequent visits to the Emergency Department(ED). Despite research that has demonstrated the prevalence of alcohol problems in ED patients, there are limited data on the effectiveness of brief intervention (BI) strategies for patients in this setting. The purpose of the current study is to evaluate the effectiveness of a brief intervention, termed Brief Negotiation Interview (BNI), provided by emergency practitioners (EPs-emergency physicians and physician assistants), in reducing alcohol consumption in ED patients with hazardous and harmful drinking. In a controlled randomized clinical trial of 500 patients with hazardous and harmful drinking, BNI will be compared to scripted discharge instructions (DI). Three hypotheses will be tested: BNI is superior to DI in: 1) reducing alcohol consumption; 2) reducing the number of binge drinking episodes; and 3) increasing utilization of primary care or alcohol-related services. Alcohol consumption and utilization of primary care or alcohol-related services will be measured by self-report at 1,6 and 12 months. An additional benefit to changing patterns of consumption and utilization of health services may be decreased ED visits and alcohol-related hospitalizations. These will be assessed utilizing a statewide database. In order to facilitate real-world application of BNI in the ED, the project will result in a BNI manual for EPs and an adherence and competence scale. Unique features of the current project as compared to earlier studies include: 1)use of a credible control condition; 2) enrollment of a heterogeneous population; 3)use of a manual-guided intervention by existing ED staff; 4)systematic assessment of adherence and competence to ensure quality administration and discriminability of interventions; 5)monitoring of use of ancillary treatments; and 6)monitoring of repeat ED visits and alcohol-related hospitalizations.
- Conditions
- Harmful Drinking, Hazardous Drinking
- Being tested
- Brief Negotiation Interview (BNI), Discharge Instructions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Negotiation Interview (BNI)Behavioural
The Brief Negotiation Interview is a manual guided intervention using techniques based on motivational interviewing, brief advice, and behavioral contracting and is designed to be delivered in less than 10 minutes.
Discharge InstructionsBehavioural
Used as a placebo comparator, scripted discharge instructions are to be read by emergency practitioner and designed to be less than 1 minute in length.
| Study group | Role | What they receive |
|---|---|---|
| Brief Negotiation Interview | Experimental | The Brief Negotiation Interview is a manual guided intervention using techniques based on motivational interviewing, brief advice, and behavioral contracting and is designed to be delivered in less than 10 minutes. Receives: Behavioral: Brief Negotiation Interview (BNI) |
| Discharge Instructions | Placebo comparator | Scripted discharge instructions to be read by emergency practitioner and designed to be less than 1 minute in length. Receives: Behavioral: Discharge Instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Drinks Consumed Daily for the Past 30 Days
Measured: Baseline (Before Intervention)
Number of Drinks Consumed Per Week
Measured: After 6 Months
Number of Drinks Consumed Per Week
Measured: After 12 Months
Number of Binge Episodes in the Past 30 Days
Greater than 4 drinks for women and greater than 5 drinks for men
Measured: After 6 Months
Number of Binge Episodes in the Past 30 Days
Greater than 4 drinks for women and greater than 5 drinks for men
Measured: After 12 Months
Secondary outcomes (4)
Contemplation Ladder Scores
A brief measure of motivation or readiness to change, allowing patients to indicate their motivation to change their drinking from 1 to 10, in which 2 is least motivated and 10 is most motivated.
Measured: After 6 Months
Contemplation Ladder Scores
A brief measure of motivation or readiness to change, allowing patients to indicate their motivation to change their drinking from 1 to 10, in which 2 is least motivated and 10 is most motivated.
Measured: After 12 Months
Short Form Health Survey
Assess health status in 2 domains, physical and mental, including summary measures and overall general health perceptions.
Measured: After 6 Months
Short Form Health Survey
Assess health status in 2 domains, physical and mental, including summary measures and overall general health perceptions.
Measured: After 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2007 (estimated)
- Study startMay 2002
- Primary completionNov 2004
- Study completionNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Harmful DrinkingStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Gail D'Onofrio, MD, MS, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00443183
- Sponsor's protocol ID
- 9906010726
- Other IDs
- 5R01AA012417-03
- Status last verified
- Aug 2016
- First submitted
- 1 Mar 2007
- Last updated
- 30 Mar 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Physician Brief Interventions for Alcohol
- ClinicalTrials.gov ID
- NCT00443183
- Acronym / sponsor ID
- 9906010726
- Conditions
- Harmful Drinking, Hazardous Drinking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- May 2002
- Primary completion
- Nov 2004 (actual)
- Study completion
- Nov 2004 (actual)
- First posted
- 5 Mar 2007 (estimated)
- 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.
Patients with hazardous and harmful alcohol consumption are at increased risk for adverse health consequences and have frequent visits to the Emergency Department(ED). Despite research that has demonstrated the prevalence of alcohol problems in ED patients, there are limited data on the effectiveness of brief intervention (BI) strategies for patients in this setting. The purpose of the current study is to evaluate the effectiveness of a brief intervention, termed Brief Negotiation Interview (BNI), provided by emergency practitioners (EPs-emergency physicians and physician assistants), in reducing alcohol consumption in ED patients with hazardous and harmful drinking. In a controlled randomized clinical trial of 500 patients with hazardous and harmful drinking, BNI will be compared to scripted discharge instructions (DI). Three hypotheses will be tested: BNI is superior to DI in: 1) reducing alcohol consumption; 2) reducing the number of binge drinking episodes; and 3) increasing utilization of primary care or alcohol-related services. Alcohol consumption and utilization of primary care or alcohol-related services will be measured by self-report at 1,6 and 12 months. An additional benefit to changing patterns of consumption and utilization of health services may be decreased ED visits and alcohol-related hospitalizations. These will be assessed utilizing a statewide database. In order to facilitate real-world application of BNI in the ED, the project will result in a BNI manual for EPs and an adherence and competence scale. Unique features of the current project as compared to earlier studies include: 1)use of a credible control condition; 2) enrollment of a heterogeneous population; 3)use of a manual-guided intervention by existing ED staff; 4)systematic assessment of adherence and competence to ensure quality administration and discriminability of interventions; 5)monitoring of use of ancillary treatments; and 6)monitoring of repeat ED visits and alcohol-related hospitalizations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief Negotiation Interview | Experimental | Behavioral: Brief Negotiation Interview (BNI)The Brief Negotiation Interview is a manual guided intervention using techniques based on motivational interviewing, brief advice, and behavioral contracting and is designed to be delivered in less than 10 minutes. |
| Discharge Instructions | Placebo comparator | Behavioral: Discharge InstructionsScripted discharge instructions to be read by emergency practitioner and designed to be less than 1 minute in length. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients, 18 years or older who present to the adult ED at Yale-New Haven Hospital will be screened for the NIAAA criteria for at risk drinking( ) namely:
Key exclusion criteria (12 listed)
- Non-English speaking;
- Pregnancy;
- Alcohol dependence;
- Current enrollment in substance abuse treatment program;
- Current cocaine or illicit opiate use;
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 |
|---|---|---|
| Brief Negotiation Interview (BNI)The Brief Negotiation Interview is a manual guided intervention using techniques based on motivational interviewing, brief advice, and behavioral contracting and is designed to be delivered in less than 10 minutes. | Behavioural | Brief Negotiation Interview |
| Discharge InstructionsUsed as a placebo comparator, scripted discharge instructions are to be read by emergency practitioner and designed to be less than 1 minute in length. | Behavioural | Discharge Instructions |
Primary outcome
Number of Drinks Consumed Daily for the Past 30 Days
Time frame: Baseline (Before Intervention)
Number of Drinks Consumed Per Week
Time frame: After 6 Months
Number of Drinks Consumed Per Week
Time frame: After 12 Months
Number of Binge Episodes in the Past 30 Days
Time frame: After 6 Months
Greater than 4 drinks for women and greater than 5 drinks for men
Number of Binge Episodes in the Past 30 Days
Time frame: After 12 Months
Greater than 4 drinks for women and greater than 5 drinks for men
4 secondary outcomes
Contemplation Ladder Scores
Time frame: After 6 Months
Contemplation Ladder Scores
Time frame: After 12 Months
Short Form Health Survey
Time frame: After 6 Months
Short Form Health Survey
Time frame: After 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
Related trials for Harmful Drinking
Active, not recruiting
Improving Help-seeking Propensity Through a Micro-intervention Targeting Common Concerns Among Individuals With Alcohol Problems: A Randomized Controlled Experiment
Alcohol Abuse, Harmful Alcohol Use
Not yet recruiting
Telephone-Based Acceptance and Commitment Therapy for Young Adult Hazardous Drinkers
Hazardous Drinking, Harmful Alcohol Use
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Guided Internet-Based Treatment for Harmful Alcohol Use; eBehandling Alkohol
Harmful Alcohol Use
Active, not recruitingObservational study
Alcohol and the Social Brain: An Alcohol-Administration Hyperscanning Study
Alcohol Drinking, Alcohol Use Disorder
Recruiting
Alcohol and the Social Brain: An Alcohol-Administration Hyperscanning Study Employing a Within-Subject Design
Alcohol Drinking, Alcohol Use Disorder (AUD)
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.
Gail D'Onofrio, MD, MS principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Negotiation Interview (BNI) and Discharge Instructions in people with Harmful Drinking and Hazardous Drinking, run by Yale University 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 4 inclusion and 12 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 30 Mar 2020. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Drinks Consumed Daily for the Past 30 Days (time frame: Baseline (Before Intervention)). The study lists 5 primary outcomes in all. 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 30 Mar 2020; AzTrials last refreshed its copy on 31 Oct 2026.