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Combination SBIRT for Emergency Department Patients Who Drink and Smoke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01595178
Recruitment Status : Completed
First Posted : May 9, 2012
Last Update Posted : June 26, 2020
Information provided by (Responsible Party):
Yale University

Brief Summary:

Smoking and drinking are two of the three leading causes of preventable deaths in the United States today. Using both alcohol and tobacco significantly multiplies the risk of disease and death from myocardial infarction, COPD, and multiple cancers. Combined use of these substances is extremely common; people who drink are three times more likely than the general population to smoke, and tobacco dependent individuals are four times more likely than the general population to be alcohol-dependent.

Research has shown that there is a high prevalence of unmet substance abuse treatment need among adult Emergency Department (ED) patients. The current project aims to conduct a pilot feasibility study with 50 adult ED patients to develop a brief counseling intervention that is feasible and acceptable to patients who are both smokers and at-risk drinkers to help them reduce these behaviors.

The overarching aim of this line of research is to find the best treatment for ED patients who are combo smokers and at-risk drinkers. The study will focus on the development of an intervention that will be tested in a future larger scale randomized clinical trial.

Condition or disease Intervention/treatment Phase
Smoking Drinking Behavioral: Combined BNI Early Phase 1

Detailed Description:

Smoking and drinking are the most common addictions in this country and frequently co-occur. Among persons who smoke and drink, there appears to be a robust dose-response relationship, with heavier drinking associated with heavier smoking and vice versa. Additionally, smokers who are more alcohol dependent often report that smoking is a common way to cope with the urge to drink.

Research has shown that there is a high prevalence of unmet substance abuse treatment need among adult Emergency Department (ED) patients. As many as 46% of ED patients have recently consumed alcohol and a significant number of the 31.6 million ED injury related visits are alcohol related. The prevalence rate of tobacco use among ED patients is reportedly as high as 40% and contributes to significant morbidity and mortality.

For many the ED is the only place they can access medical care. Although most medically-underserved individuals never seek out specialized treatment for smoking or drinking, each year over 120 million people visit an ED. Since an ED visit may be a patient's only point of contact with the health care system, it represents an important opportunity not only to treat their emergent needs, but to screen and provide this vulnerable population with appropriate alcohol and tobacco use interventions.

The intervention, built upon the Brief Negotiated Interview (BNI) model, aims to help patients reduce harmful drinking and smoking and will be initiated during an ED visit followed by 3 follow up COMBINE counseling telephone sessions post ED visit.

The specific aims of the proposed project are to:

Aim 1: To develop an effective brief intervention for smoker- drinkers that is feasible and acceptable for patients treated in the emergency department

Aim 2: To identify barriers to treatment engagement and factors that facilitate successful engagement in alcohol and smoking cessation treatment

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Development of a Combined Screening and Intervention Program for Emergency Department Patients Who Both Drink and Smoke
Study Start Date : June 2012
Actual Primary Completion Date : May 8, 2014
Actual Study Completion Date : May 8, 2014

Intervention Details:
  • Behavioral: Combined BNI
    Combination brief negotiated interview (BNI) for patients who smoke and drink

Primary Outcome Measures :
  1. Areas in need of help [ Time Frame: 3 months ]
    Descriptive summary of patient reports of areas in need of help as reported during assessments

  2. Barriers and facilitators to accessing care [ Time Frame: 3 months ]
    Descriptive summary of patient reports of barriers and facilitators encountered in trying to access needed alcohol and smoking cessation treatments

  3. Counseling satisfaction [ Time Frame: 3 months ]
    Patient reports of satisfaction with counseling modules delivered

Secondary Outcome Measures :
  1. Treatment utilization [ Time Frame: 3 months ]
    Number of contacts with treatment resources for alcohol and tobacco cessation

  2. Reduction of consumption [ Time Frame: 3 months ]
    Patient self reported reductions in smoking and drinking

  3. Quit attempts [ Time Frame: 3 months ]
    Number of quit attempts (smoking and drinking)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Adults = or > 18 years old
  • English speaking
  • Willing and able to give informed consent
  • Current daily smoker
  • Smokes 5 or more cigarettes daily
  • Alcohol screening score =/> than 8 and =< 19

Exclusion Criteria:

  • Too ill to consent
  • Not interested in quitting drinking and smoking
  • Current use of smoking / alcohol use cessation medications / products
  • Current involvement in alcohol or smoking treatment program
  • Doe not have locator information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01595178

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United States, Connecticut
Yale New Haven Hospital Emergency Department
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
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Principal Investigator: Mary K Murphy, PhD Yale University
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Responsible Party: Yale University Identifier: NCT01595178    
Other Study ID Numbers: 1205010294
First Posted: May 9, 2012    Key Record Dates
Last Update Posted: June 26, 2020
Last Verified: June 2020
Keywords provided by Yale University:
counseling intervention
emergency department
Additional relevant MeSH terms:
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Disease Attributes
Pathologic Processes