NCT01595178

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 9, 2012

Completed
23 days until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2014

Completed
Last Updated

June 26, 2020

Status Verified

June 1, 2020

Enrollment Period

1.9 years

First QC Date

May 7, 2012

Last Update Submit

June 24, 2020

Conditions

Keywords

smokingdrinkingSBIRTBNIcounseling interventionemergency departmentadults

Outcome Measures

Primary Outcomes (3)

  • Areas in need of help

    Descriptive summary of patient reports of areas in need of help as reported during assessments

    3 months

  • Barriers and facilitators to accessing care

    Descriptive summary of patient reports of barriers and facilitators encountered in trying to access needed alcohol and smoking cessation treatments

    3 months

  • Counseling satisfaction

    Patient reports of satisfaction with counseling modules delivered

    3 months

Secondary Outcomes (3)

  • Treatment utilization

    3 months

  • Reduction of consumption

    3 months

  • Quit attempts

    3 months

Interventions

Combined BNIBEHAVIORAL

Combination brief negotiated interview (BNI) for patients who smoke and drink

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale New Haven Hospital Emergency Department

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

SmokingEmergencies

Condition Hierarchy (Ancestors)

BehaviorDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mary K Murphy, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2012

First Posted

May 9, 2012

Study Start

June 1, 2012

Primary Completion

May 8, 2014

Study Completion

May 8, 2014

Last Updated

June 26, 2020

Record last verified: 2020-06

Locations